EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX   
SANCO/13001/2011 Rev. 5 (POOL/G4/2011/13001/13001R5-EN 
CIS.doc) 
[…](2012) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amendin g the Annexes to Re gulation (EC) No 999/2001 of th e European Parliament and 
of the Council laying down rules for the prevention, control and eradication of certain 
transmissible spongiform encephalopathies 
(Text with EEA relevance) 
 EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending the Annexes to Regulation (EC) No 999/2001 of the European Parliament and 
of the Council laying down rules for the p revention, control and eradication of certain 
transmissible spongiform encephalopathies 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the 
Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible sp ongiform encephalopathies
1, and in particular the first paragraph of 
Article 23 thereof, 
Whereas: (1) Regulation (EC) No 999/2001 lays down ru les for the preven tion, control and 
eradication of transmissible spongiform en cephalopathies (TSEs) in bovine, ovine and 
caprine animals. It applies to the producti on and placing on the market of live animals 
and products of animal origin and in cer tain specific cases to exports thereof. 
(2) On 19 January 2011, the European Food Safe ty Authority (EFSA) published a joint 
opinion prepared with the European Centre for Disease Prevention and Control (ECDC) on any possible epidemiological or molecular association between TSEs in 
animals and humans ('the joint EFSA and ECDC Opinion')
2. In the joint EFSA and 
ECDC opinion, the EFSA and ECDC confirmed the identification of atypical forms of 
bovine spongiform encephalopathy (BSE) in cattle and made the distinction between 
classical BSE, L-type atypical BSE and H-type atypical BSE. It is therefore 
appropriate to insert definitions for cla ssical BSE cases and atypical BSE cases in 
Annex I to Regulation (EC) No 999/2001. 
(3) Part I of Chapter A of Annex III to Regul ation (EC) No 999/2001 lays down rules for 
monitoring BSE in bovine animals slaughtered  for human consumption. It refers to 
animals slaughtered in accordance with 'special emergency slaughter' as defined in Article 2(n) of Council Dir ective 64/433/EEC of 26 June 1964 on health conditions for 
the production and marketing of fresh meat
3. That Directive has since been repealed 
                                                 
1 OJ L 147, 31.5.2001, p. 1. 
2 EFSA Journal 2011;9(1):1945 
3 OJ 121, 29.7.1964, p. 2012. EN 3   EN by Directive 2004/41/EC of the Europ ean Parliament and of the Council4. This has led 
to legal uncertainty and caused reduced test ing in animals that should have been 
tested. It is therefore necessary to clearly define emergency slaughter in the framework 
of the rules for monitoring BSE in bovine animals slaughtered for human consumption in Annex III to Regulation (EC) No 999/2001. 
(4) Part II of Chapter A of Anne x III to Regulation (EC) No  999/2001 lays down rules for 
monitoring in ovine and caprine animals.  The annual reports carried out by the 
Member States on the monitoring and tes ting of ruminants for the presence of 
Transmissible Spongiform Encephalopathy (T SE) in the Union has shown in recent 
years that the testing of ovine and caprine animals not slaughtered for human 
consumption is usually more efficient to identify cases of TSE than the testing of animals slaughtered for human consumption. More flexibility s hould therefore be 
given to the Member States to focus a la rger part of the limited number of tests 
required by that Annex in the subpopulations where there is a greater chance to 
identify such cases. 
(5) Annex VII to Regulation (EC) No 999/2001 la ys down the eradication measures to be 
carried out following the conf irmation of the presence of TSE in bovine, ovine and 
caprine animals and the minimum requi rements for breeding programmes for 
resistance to TSEs in sheep. That Annex ha s been amended several times, including by 
Commission Regulations (EC) No 727/2007
5 and (EC) No 746/20086.  
(6) On 17 July 2007, in Case T-257/07, France br ought an action agai nst the Commission 
before the General Court, applying for the suspension of the operation of point (3) of 
the Annex to Regulation (EC) No 727/2007 in sofar as it introduces point 2.3(b)(iii), 
point 2.3(d) and point 4 into Chapter A of Annex VII to Regulation (EC) No 
999/2001, or alternatively the entire annulme nt of that Regulation. According to 
France, those points would authorise less restrictive measures of surveillance and 
eradication than those earlier prescribed for sheep and goats. In its Order of 28 
September 20077, the Court suspended the applica tion of those provisions until 
judgment would be given in the main action. 
(7) The Commission subsequently asked the EFSA to assist it in clarifying the main 
premises on which Regulation (EC) No 727/2007 was based. In view of the EFSA clarifications, Regulation (EC) No 999/ 2001 was amended by Regulation (EC) No 
746/2008, which reinstated provisions the applic ation of which had been suspended by 
the General Court. In its Order of 30 October 2008
8, the General Court suspended the 
application of point 2.3(b)(iii ), point 2.3(d) and point 4 of  Chapter A of Annex VII to 
Regulation (EC) No 999/2001, as amende d by Regulation (EC) No 746/2008, until 
judgment would be given in th e main action in Case T-257/07. 
(8) In its judgment of 9 September 2011 in Case T-257/079, the General Court dismissed 
the application by France for the annul ment of Regulation (EC) No 746/2008, and 
                                                 
4 OJ L 157, 30.4.2004, p. 33. 
5 OJ L 165, 27.6.2007, p. 8.  
6 OJ L 202, 31.7.2008, p. 11. 
7 OJ C 283, 24.11.2007, p. 28. 
8 OJ C 327, 20.12.2008, p. 26. 
9 OJ C 311, 22.10.2011, p. 33. EN 4   EN lifted the suspension of the application of those provisions of Ch apter A of Annex VII 
to Regulation (EC) No 999/2001. 
(9) On 28 November 2011, in Case C-601/11 P10, an appeal was brought by France 
against the judgment of the General court in Case T-257/07, requesting the Court to 
set aside the judgment of the General Court in Case T-257/07 and to give final judgment in the dispute by annulling Regulat ion (EC) No 746/2008 or  to refer the case 
back to the General Court. 
(10) It is appropriate to clarify the very co mplex construct of management options and 
derogations for the control and eradication of classical scrapie in ovine and caprine 
animals set out in Annex VII to Regulat ion (EC) No 999/2001. Annex VII should only 
provide for three options in infected flocks  or herds of ovine and caprine animals, 
namely: option 1 for the elimination of all an imals; option 2 for the elimination of the 
susceptible animals only; and option 3 for no mandatory elimination of animals.  
(11) The measures to be applied in each of those three options should be re-drafted in order 
to facilitate comparison between the options and improve awareness of the consequences for the individual holding. As  option 1 and option 2 include stringent 
eradication measures which improve diseas e control, the post-eradication measures 
enforced under option 1 and option 2 shoul d be more flexible than under option 3. 
(12) It is necessary to clarify th e conditions under which the elim ination measures set out in 
option 2 may be delayed. It is appropriate  to allow for a short term delay not 
exceeding three months linked to lambing season considerations. However, a long 
term delay can only be justified by the need of  additional time to increase the level of 
genetic resistance to classical scrapie in a holding. Since genetic resistance to classical 
scrapie has so far been prove n only in ovine animals, the long term delay should not 
be permitted for herds comprising only caprine animals. When permitted, it should be limited to a period of three y ears under certain conditions. 
(13) Where classical scrapie is confirmed in hol dings keeping a local ovine breed in danger 
of being lost to farming, the post-eradica tion measures laid down in Annex VII to 
Regulation (EC) No 999/2001 sh ould take into consider ation the difficulty of 
introducing and using only resistant ovine an imals or ovine germinal products of the 
same endangered breed. In this particular case, Member States should be permitted to apply more flexible rules regarding the genotype of breeders a nd germinal products 
introduced and used in the holdings. 
(14) The joint EFSA and ECDC Opinion suggests that  atypical scrapie coul d be little or not 
contagious at all. That finding mainly relies  on the lack of statis tical difference of the 
observed Atypical/Nor98 frequencies between  the general population and the flocks 
where a positive case had been identified. Therefore, restriction measures on the movement of ovine and caprine animals where a case of atypical scrapie has been confirmed are no longer justif ied. Increased surveillance in  those flocks or herds 
should, however, be maintained in order to gather more scientific data on atypical 
scrapie. This amendment to Annex VII to Regulation (EC) No 999/2001 is in line with 
the future policy options envisaged by pa ragraph 2.4.3 of the Communication from the 
                                                
 
10 OJ C 80, 17.3.2012, p. 5. EN 5   EN Commission to the European Parliament and the Council - The TSE Road map 2 - A 
Strategy paper on Transmissible S pongiform Encephalopathies for 2010-201511. 
(15) The participation in breeding programmes has been so far limited to ovine flocks of 
high genetic merit. Where they have been  applied, the breeding programmes have 
been effective in increasing the resistance to  classical scrapie in the high genetic merit 
sheep population. But the diffusion in the ordinary production population of the 
hereditary factor (allele) carrying the resist ance appears to have been limited so far. 
Chapter C of Annex VII to Regulation (E C) No 999/2001 should allow the genotyping 
of the breeding rams of flocks  not participating in the br eeding programme in order to 
facilitate a broader diffusion of the resist ance factor to clas sical scrapie in the 
production population. 
(16) Chapter A of Annex VIII to Regulation (EC) No 999/2001 lays down rules governing 
intra-Union trade in live animals, semen a nd embryos. As referred to in recital 14, the 
joint EFSA and ECDC Opinion suggests that  atypical scrapie coul d be little or not 
contagious at all. The lifting of all restri ction measures on the m ovement of ovine and 
caprine animals where a case of atypical sc rapie has been confirmed should therefore 
apply to intra-Union trade. This position is also supported by the fact that the 
Terrestrial Animal Health Code, as voted in 2010 at the 78th General Session of the 
World Organisation for Animal Health  (OIE), does not recommend any trade 
restriction with regards to atypical scrapie. 
(17) The rules set out in Annex VIII to Regulation (EC) No 999/2001 relating to intra-
Union trade in ovine and caprine animal s and their semen and embryos should be 
made as consistent as possible with the OIE standards, so that they do not preclude a Member States with an approved national control programme fo r classical scrapie 
from claiming the country freedom status  for classical scrapie according to the 
conditions laid out in the OIE code. The am ended intra-Union trade provisions should 
however not adversely impact existing intr a-Union trade flows among Member States 
where no national control programme for classical scrapie has been approved. 
(18) For that purpose, and as proposed in paragraph 2.4.3 of the TSE Roadmap 2, a 
framework enabling the Member States to establish an official scheme for the 
recognition of classical scrapie status in holdings should be set out in Annex VIII to 
Regulation (EC) No 999/2001. The possibility fo r a holding to engage in intra-Union 
trade of ovine and caprine animals, with regards to classical scrapie, should be 
determined by its classical scrapie status.  
(19) A two tiered system for classical scrapie st atus in holdings shoul d be established in 
Annex VIII to Regulation (EC) No 999/2001. A ne gligible risk status, equivalent in 
technical terms to the scrapie free status in a holding, as laid down in Article 14.9.5. of 
the OIE Terrestrial Animal Health code and based on compliance with the full list of 
the OIE requirements for at least seven years (in line with the rule laid down in article 
6a and Annex VII to Regulation (EC) No 999/2001 favouring the development of the resistant genotypes in ovines, the pr oposal however recognises the ARR/ARR 
genotype as a valid option), should be requi red for transporting animals for breeding 
and rearing to the Member States with an  approved national c ontrol programme for 
                                                
 
11 COM(2010)384 final. EN 6   EN classical scrapie. Animals for breeding in tended to other Member States should only 
be required to come from holdings with a c ontrolled risk of classical scrapie based on 
compliance with a shorter list of requirements for at least three years, as is presently the case. 
(20) Considering the difficulty to demonstrate freedom in the territory of part of the 
territory of a Member State for a disease as  complex as classical scrapie, which is 
characterised by a long incubation delay, the absence of any in-v ivo diagnostic method 
and a variable individual susceptibility of the animals depending on their genetic 
profile, the concept of 'classical scrapie free Member State' should be replaced in 
Annex VIII to Regulation (EC) No 999/2001 by that of 'Member St ate or zone of a 
Member State with a negligible risk of classical scrapie'. The conditions for the 
recognition of a Member State or zone of a Member State with a negligible risk of 
classical scrapie should also be update d and largely brought in line with the 
recommendations laid down in Article 14.9.3 of the OIE Terrestrial Animal Health 
code. 
(21) As Annex VIII to Regulation (EC) No 999/ 2001 should cover all trade aspects related 
to classical scrapie, and cons idering that the proposed creation of an official scheme 
for the recognition of classical scrapie status in holdings constitutes an appropriate basis for establishing differentiated guaranties for animals to be traded with Member States with an approved national control pl an for classical scrapie and with other 
Member States, that Annex s hould also include the list of  Member States with an 
approved national control plan  for classical scrapie. 
 
(22) Chapter C of Annex IX to Regulation (E C) No 999/2001 lays dow n rules relating to 
imports into the Union of products of anim al origin from bovine, ovine and caprine 
animals, in particular gela tine intended for human consumption. Section A of Chapter 
D of Annex IX to Regulation (EC) No 999/2001 lays down rules related to imports 
into the Union of animal by-products and derived products from bovine, ovine and 
caprine origin, in particular gelatine intend ed to be used as feed ingredient. Since 
collagen intended to be used for food or f eed is produced from the same raw materials 
as gelatine, import conditions for collagen to be used for food or feed should be 
aligned with those laid down for ge latine intended for the same usage. 
(23) Section B of Chapter D of Annex IX to Regulation (EC) No 999/2001 provides 
specific attestations which are to accompany imports into the Union of certain animal 
by-products and derived products of bovi ne, ovine and caprine origin. Those 
attestations should be amended in order to al so apply to products processed in a third 
country classified as posing a controlled or  undetermined BSE risk and made from 
mixed material originating from this third c ountry as well as from a third country with 
a negligible BSE risk. The specific attest ation regarding the importation of products 
containing milk of ovine and caprine origin  and intended for feeding farmed animals 
should also be amended to better reflect the restrictions applicable  to intra-Union trade 
in these products. 
(24) Chapters E and H of Annex IX to Regulat ion (EC) No 999/2001 lay down rules for the 
importation in the Union of ovine and caprine animals, and ovine and caprine semen 
and embryos. Those import rules should be updat ed to reflect the conditions for intra-
Union trade laid down in Annex VIII to Regulation (EC) No 999/2001, including the general pre-requisites in  terms of monitoring and eradicat ion of classical scrapie laid EN 7   EN down in Annexes III and V II to Regulation (EC) No 999/2001, as well as feed ban 
provisions laid down in Annex IV  to Regulation (EC) No 999/2001. 
(25) Annex X to Regulation (EC) No 999/2001 lays down the methods of analysis 
applicable to TSE testing in bovine, ovine and caprine animals. The joint EFSA and 
ECDC Opinion indicated that the L-type  Atypical BSE agent has a significant 
zoonotic potential (transmission from animals to humans), which appears similar or 
even higher than that of the Classical BSE agent. L-type and H-t ype cases of atypical 
BSE have been identified in several countries throughout the world and EFSA 
indicated that the unusually old age of all H-BSE and L-BSE identif ied cases and their 
apparent low prevalence in the populati on could suggest that these Atypical BSE 
forms are arising spontaneously. In order to gain more knowledge on atypical BSE, 
more relevant data n eed to be gathered.  
(26) For that purpose, it is necessary to require that material from all future cases of BSE 
confirmed in the Union is submitted to discriminatory tests that allow the precise identification of the agent, namely classical BSE, L-type atypical BSE and H-type atypical BSE. As certain Member States and third countries ha ve already published 
details of the phenotype of th eir recent BSE cases, discrimi natory testing of future 
BSE cases confirmed in the Union should be  made mandatory in Chapter C of Annex 
X to Regulation (EC) No 999/2001. 
(27) As Member States need sufficient time to adapt their national instructions to the new 
requirements introduced by this Regulation, this Regulation should apply on 1 July 
2013. 
(28) Regulation (EC) No 999/2001 should therefore be amended accordingly. 
(29) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The Annexes to Regulation (EC) No 999/2001 ar e amended in accordance with the Annex to 
this Regulation. 
Article 2 
This Regulation shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union . 
It shall apply from 1 July 2013. This Regulation shall be binding in  its entirety and directly applicable in all Member States. EN 8   EN Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO EN 9   EN ANNEX  
The Annexes to Regulation (EC) No 999/2001 are amended as follows: 
(1) In Annex I, point 2 is replaced by the following: 
'2. For the purpose of this Regulation, the following definitions shall also apply: 
(a) ‘BSE indigenous case’ means a case of bovine spongiform 
encephalopathy which has not been cl early demonstrated to be due to 
infection prior to importation as a live animal; 
(b) ‘cohort’ means a group of bovine animals which includes both: 
(i) animals born in the same herd as the affected bovine animal, and 
within 12 months preceding or foll owing the date of birth of the 
affected bovine animal; and 
(ii) animals which at any time during the first year of their lives were 
reared together with the affected bovine animal duri ng the first year 
of its life; 
(c) ‘index case’ means the first animal on a holding, or in an 
epidemiologically defined group, in wh ich a TSE infection is confirmed; 
(d) ‘TSE in small ruminants’ me ans a transmissible spongiform 
encephalopathy case detected in an ovine or caprine animal following a 
confirmatory test for abnormal PrP protein; 
(e) ‘scrapie case’ means a transmissible spongiform encephalopathy 
confirmed case in an ovine or caprine  animal where a diagnosis of BSE 
has been excluded in accordance with  the criteria laid down in the 
Community reference laboratory' s technical handbook on TSE strain 
characterisation in small ruminants (*); 
(f) ‘classical scrapie case’ means a sc rapie confirmed case classified as 
classical in accordance with the criteria laid down in the European Union 
reference laboratory's technical han dbook on TSE strain characterisation 
in small ruminants; 
(g) ‘atypical scrapie case’ means a sc rapie confirmed case which is 
distinguishable from classical scrapi e in accordance with the criteria laid 
down in the European Union refere nce laboratory's technical handbook 
on TSE strain characterisation in small ruminants; 
(h) 'Prion protein genotype' in ovine animals means a combination of two 
alleles as described in point 1 of  Annex I to Commission Decision 
2002/1003/EC (**). 
(i) 'BSE case' means a case of BSE c onfirmed in a national reference 
laboratory according to the methods a nd protocols in point 3.1.(a) and (b) 
of Chapter C of Annex X; EN 10   EN (j) ‘classical BSE case’ means a BSE case classified as such in accordance 
with the criteria laid down in the European Union reference laboratory's 
method for the classification of  bovine TSE isolates (***); 
(k) ‘atypical BSE case’ means a BSE case which cannot be classified as a 
classical BSE case in accordance with  the criteria la id down in the 
European Union reference laboratory 's method for the classification of 
bovine TSE isolates; 
(l) 'ovine and caprine animals over 18 months of age' means ovine and 
caprine animals:  
(i) whose age is confirmed by the registers or movement documents 
referred to in point 1(b), (c) and (d) of Article 3 of Council 
Regulation (EC) No 21/2004 (****) , or  
(ii) which have more than two perm anent incisors erupted through the 
gum.  
(*) http://vla.defra.gov.uk/science/ docs/sci_tse_rl_handbookv4jan10.pdf  
(**) OJ L 349, 24.12.2002, p. 105. (***) http://vla.defra.gov.uk/scienc e/docs/sci_tse_rl_2blot.pdf
 
(****) OJ L 5, 9.1.2004, p. 8.’ EN 11   EN (2) In Annex III, Chapter A is amended as follows: 
(a) In Part 1, point 2 is replaced by the following: 
'2. Monitoring in animals slaughtered for human consumption 
2.1. All bovine animals over 24 months of age shall be tested for BSE 
where they have undergone:  
– emergency slaughter in accordance with point I of Chapter VI 
of Annex III to Regulation (EC) No 853/2004 (*), or 
– an ante mortem inspection w ith observations concerning 
accidents, or serious physiological and functional problems, or signs in accordance with point  2 of Part B of Chapter II of 
Section I of Annex I to Regul ation (EC) No 854/2004 (**).  
2.2. All healthy bovine animals over 30 months of age slaughtered 
normally for human consumption shall be tested for BSE. 
(*) OJ L 139, 30.4.2004, p. 55. 
(**) OJ L 139, 30.4.2004, p. 206.' 
(b) Part II is amended as follows: 
(i) Point 2 is replaced by the following: 
'2. Monitoring in ovine and caprine  animals slaughtered for human 
consumption 
(a) Member States in which the population of ewes and ewe 
lambs put to the ram exceeds 750 000 animals shall test, in accordance with the sampling ru les set out in point 4, a 
minimum annual sample of 10 000 ovine animals slaughtered for human consumption;  
(b) Member States in which th e population of goats which have 
already kidded and goats mated exceeds 750 000 animals 
shall test, in accordance with the sampling rules set out in 
point 4, a minimum annual samp le of 10 000 caprine animals 
slaughtered for human consumption; 
(c) A Member State may choose to replace a maximum of: 
– 50 % of its minimum sample size of ovine and caprine 
animals slaughtered for human consumption set out in points (a) and (b) by testing dead ovine or caprine animals over the age of 18 months at the ratio of one to one and in addition to the minimum sample size set out 
in point 3; 
– 10 % of its minimum sample size set out in points (a) EN 12   EN and (b) by testing ovine or caprine animals killed in the 
framework of a disease eradication campaign over the age of 18 months at the ratio of one to one.' 
(ii) Point 5 is replaced by the following: 
'5. Monitoring in holdings unde r TSE control and eradication 
measures 
Animals over 18 months of age which are killed for destruction in 
accordance with Annex VII, Chap ter B, Part 2, point 2.2.1. and 
point 2.2.2.(b) or (c), shall be test ed for the presence of TSE in 
accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.(b), based on the selection of 
a simple random sample, in accordance with the sample size set out in the following table. 
Number of animals over 18 months 
of age killed for destruction in the 
herd or flock Minimum sample size 
70 or less All eligible animals 
80 68 
90 73 
100 78 
120 86 
140 92 
160 97 
180 101 
200 105 
250 112 
300 117 
350 121 
400 124 
450 127 
500 or more 150 
' EN 13   EN (3) Annex VII is replaced by the following: 
'ANNEX VII 
CONTROL AND ERADICATION OF TRANSMISSIBLE SPONGIFORM 
ENCEPHALOPATHIES 
CHAPTER A 
MEASURES FOLLOWING THE SUSPICION OF THE PRESENCE OF A 
TSE IN OVINE AND CAPRINE ANIMALS 
If a TSE is suspected in an ovine or capri ne animal on a holding in a Member State 
and until the results of the confirmatory examinations ar e available, all other ovine 
and caprine animals on that holding shal l be placed under an official movement 
restriction.  
If there is evidence that the holding where the animal was present when the TSE was 
suspected is unlikely to be the holding wher e the animal could have been exposed to 
the TSE, the Member State may decide th at other holdings or only the holding of 
exposure shall be placed under official control, dependi ng on the epidemiological 
information available.  
The milk and the milk products derived fr om the ovine and caprine animals of a 
holding placed under official control, which are present on that holding from the date 
when the presence of the TSE is suspect ed until the results of the confirmatory 
examinations are available, shall only be used within that holding.  
CHAPTER B 
MEASURES FOLLOWING CONFIRMATION OF THE PRESENCE OF A 
TSE IN BOVINE, OVINE AND CAPRINE ANIMALS 
1. The inquiry referred to in Ar ticle 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 a period of two years prior to, or after, the 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 EN 14   EN by the TSE agent or been exposed to the same feed or 
contamination source, 
– the movement of potentially contaminated feedingstuffs, of other 
material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question; 
(b) in the case of ovine and caprine animals: 
– all ruminants other than ovine and caprine animals on the holding 
of the animal in which th e disease was confirmed, 
– insofar as they are identifiable, the parents, and in the case of 
females all embryos, ova and the last progeny of the female animal in which the disease was confirmed, 
– all other ovine and caprine animal s on the holding of the animal in 
which the disease was confirmed in addition to those referred to in the second indent, 
– the possible origin of the disease and the identification of other 
holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source, 
– the movement of potentially cont aminated feedingstuffs, other 
material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question. 
2. The measures laid down in Article 13(1)(c) shall comprise at least the 
following: 
2.1. In the case of confirmation of BSE in a bovine animal, the killing and 
complete destruction of bovine animal s identified by the inquiry referred 
to in the second and third indents of point 1(a); however, the Member 
State may decide: 
– not to kill and destroy animals of the cohort referred to in the third 
indent of point 1(a) if  evidence has been provided that such animals 
did not have access to the same feed as the affected animal, 
– to defer the killing and destructio n of animals of the cohort referred 
to in the third indent of point 1( a) until the end of their productive 
life, provided that they are bu lls continuously kept at a semen 
collection centre and it can be ensured that they are completely destroyed following death. EN 15   EN 2.2. In the case of confirmation of TSE in an ovine or caprine animal: 
2.2.1. In cases where BSE cannot be excluded  
If BSE cannot be excluded after th e results of a ring trial carried 
out in accordance with the methods  and protocols set out in Annex 
X, Chapter C, Part 3, point 3.2(c), the killing and complete destruction, without delay, of all animals, embryos and ova 
identified by the inquiry referred to in the second to fifth indents of 
point 1(b). 
The animals over 18 months of age killed for destru ction shall be 
tested for the presence of TSE in  accordance with the laboratory 
methods and protocols set out in An nex X, Chapter C, Part 3, point 
3.2, as laid down in Annex III, Chapter A, Part II , point 5. 
The prion protein genotype of all ovine animals, up to a maximum 
of 50, shall be determined. 
The milk and the milk products derived from the animals to be 
destroyed, which were present on the holding between the date of 
confirmation that BSE cannot be ex cluded and the date of complete 
destruction of the animals, shall be  disposed of in accordance with 
Article 12 of Regulation (EC) No 1069/2009 of the European 
Parliament and of the Council (*). 
Following the killing and complete de struction of all animals, the 
conditions set out in point 3 shall apply to the holding. 
2.2.2. In cases where BSE and atypical scrapie can be excluded
 
If BSE and atypical scrapie are excluded in accordance with the 
laboratory methods and protocols se t out in Annex X, Chapter C, 
Part 3, point 3.2(c), the holding shall be subject to the conditions 
set out in point (a) and, pursuan t to the decision of the Member 
State responsible for the holding, to  the conditions of either option 
1 set out at point (b), or option 2 se t out at point (c), or option 3 set 
out at point (d) : 
(a) The milk and milk products derived from the animals to be 
destroyed or slaughtered and which were present on the 
holding between the date of c onfirmation of the case of TSE 
and the date of the completion of the measures to be applied in the holding as laid down in point (b) and (c), or derived from the infected flock/herd until all the restrictions laid down in point (d) and point 4 ar e lifted, shall not be used for 
the feeding of ruminants, excep t for the feeding of ruminants 
within that holding. EN 16   EN  The placing on the market of su ch milk and milk products as 
feed for non-ruminants shall be limited to the territory of the Member State responsible for the holding.  
 The commercial document accompanying consignments of 
such milk and milk products and any packaging containing such consignments shall be cl early marked with the words: 
‘shall not be fed to ruminants’.  
 The use and the storage of feedingstuffs containing such milk 
and milk products shall be prohibited on holdings where 
ruminants are kept.  
 Bulk feedingstuffs containing such milk and milk products 
shall be transported by mean s of vehicles which do not 
transport feedingstuffs for ruminants at the same time.  
 If those vehicles are subsequently used for the transport of 
feedingstuffs intended for rumina nts, they shall be thoroughly 
cleaned in order to avoid cross- contamination, in accordance with a procedure approved by the Member State responsible 
for the holding. 
(b) Option 1 – killing and comple te destruction of all animals 
 The killing and complete dest ruction, without delay, of all 
animals, embryos and ova identified by the inquiry referred to in the second and thir d indents of point 1(b). 
 The animals over 18 months of  age killed for destruction 
shall be tested for the presence of TSE in accordance with the laboratory methods and protoc ols set out in  Annex X, 
Chapter C, Part 3, point 3.2, as laid down in Annex III, 
Chapter A, Part II, point 5. 
 The prion protein genotype of  all ovine animals, up to a 
maximum of 50, shall be determined.  
 By way of derogation from the conditions set out in the first 
paragraph of option 1, Member St ates may decide instead to 
carry out the measures listed in (i) or (ii): 
(i) to replace the killing and complete destruction of all 
animals, without delay, by their slaughtering for 
human consumption, without delay, provided that: 
– the animals are slaughtered for human 
consumption within the territory of the 
Member State responsible for the holding; 
– all animals which are over 18 months of age 
slaughtered for human consumption shall be 
tested for the presence  of TSE in accordance 
with the laboratory methods and protocols set EN 17   EN out in Annex X, Chapter C, Part 3, point 3.2. 
(ii) to exempt the lambs and kids less than three months 
old from killing and complete destruction without delay, provided that they are slaughtered for human consumption not later than when they are three 
months of age. 
 Pending the killing and complete  destruction or slaughtering 
for human consumption of all animals, the measures set out in point 2.2.2.(a) and point 3.4.(b)  third and fourth indents 
shall apply on the holding where it has been decided to apply option 1. 
 Following the killing and complete destruction or 
slaughtering for human consumption of all animals the conditions set out in point 3 shall apply to the holding where it has been decided to apply option 1. 
(c) Option 2 – killing and complete destruction of the susceptible 
animals only 
 The prion protein genotyping of all ovine animals present on 
the holding followed by the killin g and complete destruction, 
without delay, of all animals, embryos and ova identified by 
the inquiry referred to in th e second and third indents of 
point 1(b), with the exception of: 
– breeding rams of the ARR/ARR genotype, 
– breeding ewes carrying at least one ARR allele and 
no VRQ allele and, where such breeding ewes are pregnant at the time of  the inquiry, the lambs 
subsequently born, if their genotype meets the 
requirements of this subparagraph, 
– ovine animals carrying at least one ARR allele 
which are intended solely for slaughter for human 
consumption, 
– if the Member State res ponsible for the holding so 
decides, lambs and kids le ss than three months old 
provided that they are slaughtered for human 
consumption not later than when they are three months of age. These lambs and kids shall be 
exempted from the genotyping. 
 The animals over 18 months of  age killed for destruction 
shall be tested for the presence of TSE in accordance with the laboratory methods and protoc ols set out in  Annex X, 
Chapter C, Part 3, point 3.2, as laid down in Annex III, Chapter A, Part II, point 5. EN 18   EN  By way of derogation from the conditions set out in the first 
paragraph of option 2, Member St ates may decide instead to 
carry out the measures listed in (i), (ii) and (iii): 
(i) to replace the killing a nd complete destruction of 
the animals referred to in the first paragraph of 
option 2 by their slaughtering for human 
consumption, provided that: 
– the animals are slaughtered for human 
consumption within the territory of the 
Member State responsible for the holding; 
– all animals which are over 18 months of age 
slaughtered for human consumption shall be 
tested for the presence of TSE in accordance with the laboratory methods and protocols set 
out in Annex X, Chapter C, Part 3, point 3.2. 
(ii) to delay the genotyping and subsequent killing and 
complete destruction or slaughtering for human 
consumption of the animals referred to in the first paragraph of option 2 for a period not exceeding three months in situations where the index case is confirmed close to the commencement of the lambing season, provided that the ewes, goats and their new-born are kept isolated from ovine and caprine animals of other holdings during the whole 
period; 
(iii) to delay the killing and complete destruction or 
slaughtering for human consumption of the animals 
referred to in the first paragraph of option 2 for a maximum period of three years from the date of confirmation of the index cas e, in ovine flocks and 
holdings where ovine and caprine animals are kept together. The application of  the derogation set out in 
the present paragraph shall be limited to cases where the Member States responsible for the holding consider that the epidemiological situation cannot be handled without  killing the relevant 
animals, but that this cannot be carried out immediately due to the low level of resistance in the ovine population of the holding coupled with other considerations, including economic factors. Breeding rams other than those of the ARR/ARR genotype shall be killed or  castrated without delay 
and all possible measures  to quickly build up 
genetic resistance in the ovine population of the 
holding, including by reasoned breeding and culling of ewes to increase the frequency of the ARR allele and eliminate the VRQ allele, shall be implemented. The Member States responsible for the holding shall ensure that the number of animals to be killed at the EN 19   EN end of the period of de lay is not greater than 
immediately after the index case was confirmed. 
 Pending the killing and complete  destruction or slaughtering 
for human consumption of the animals referred to in the first paragraph of option 2, the follo wing measures shall apply on 
the holding where it has been deci ded to apply option 2: point 
2.2.2.(a), point 3.1., point 3.2.(a) and (b), point 3.3. and point 3.4.(a) first and second indents, (b) first, third and fourth 
indents, and (c). However,  where the Member States 
responsible for the ho lding decide to de lay the killing and 
complete destruction or slaughtering for human consumption of the animals in accordance with  point (iii), the following 
measures shall instead apply on the holding: point 2.2.2.(a) and points 4.1. to 4.6. 
 Following the killing and complete destruction, or 
slaughtering for human consumption of the animals referred to in the first paragraph of option 2 the conditions set out in point 3 shall apply to the hol ding where it has been decided 
to apply option 2. 
(d) Option 3 – no mandatory killing and complete destruction of 
animals 
 A Member State may decide not to kill and completely 
destroy the animals identified by the inquiry referred to in the 
second and third indents of point 1(b) where the criteria laid 
down in at least one of the following four indents are met: 
– it is difficult to obtain replacement ovine animals of 
genotypes allowed under point 3.2.(a) and (b), 
– the frequency of the ARR allele within the breed or 
holding is low, 
– it is deemed necessary in  order to avoid inbreeding, 
– it is deemed necessary by the Member State based on 
a reasoned consideration of  all the epidemiological 
factors. 
 The Member States allowing recourse to opt ion 3 in the 
management of classical scrapie outbreaks shall keep records of the reasons and criteria founding each individual application decision.  
 When additional classical scrapie cases are detected in a 
holding where option 3 is being applied, the relevance of the reasons and criteria founding the decision to apply option 3 to 
this holding shall be reassessed by the Member State. If it is concluded that applying opti on 3 does not ensure a proper EN 20   EN control of the outbreak, the Member State shall switch the 
management of this holding from option 3 to either option 1 or option 2, as laid down in points (b) and (c). 
 The prion protein genotype of  all ovine animals, up to a 
maximum of 50, shall be determined within a period of three months from the date of conf irmation of the index case of 
classical scrapie. 
 The conditions set out in point 2.2.2.(a) and point 4 shall 
immediately apply to a holding where it has been decided to 
apply option 3. 
2.2.3. In cases where atypical scrapie is confirmed 
Where the TSE case confirmed on a holding is an atypical scrapie 
case, the holding shall be subject to the following intensified TSE monitoring protocol for a period of two years from the date of the 
detection of the last atypical sc rapie case: all ovine and caprine 
animals which are over the age of  18 months and slaughtered for 
human consumption and all ovine and caprine animals over the age 
of 18 months which have died or been killed on the holding shall 
be tested for the presence of TSE in accordance with the laboratory 
methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. 
If a case of TSE other than atypical  scrapie is confirmed during the 
intensified TSE monitoring period of  two years referred to in the 
first paragraph, the holding sha ll be subject to the measures 
referred to in point 2.2.1 or point 2.2.2. 
2.3. If an animal infected with TS E has been introduced from another 
holding:  
(a) a Member State may decide, based on the history of the infected 
animal, to apply eradication measur es in the holding of origin in 
addition to, or instead of, the hol ding in which the infection was 
confirmed;  
(b) in the case of land used for common grazing by more than one 
flock or herd, Member States may decide to limit the application of 
eradication measures to a single flock or herd, based on a reasoned 
consideration of all the ep idemiological factors;  
(c) where more than one flock or he rd is kept on a single holding, 
Member States may decide to limit the application of the eradication measures to the flock or herd in which the TSE has been confirmed, provided it has been  verified that the flocks or 
herds have been kept isolated fr om each other and that the spread 
of infection between the flocks or  herds through either direct or 
indirect contact is unlikely. EN 21   EN 3. Following the killing and complete de struction or slaughtering for human 
consumption of all animals identified on  a holding, in accordance with point 
2.2.1., point 2.2.2.(b) or  point 2.2.2.(c): 
3.1. The holding shall be subjected to an  intensified TSE monitoring protocol 
including the testing for the presen ce of TSE, in accordance with the 
laboratory methods and prot ocols set out in Annex X, Chapter C, Part 3, 
point 3.2, of all of the following animals which are over the age of 18 months, except ovine animal s of the ARR/ARR genotype: 
(a) animals which were kept in the holding at the time when the TSE 
case was confirmed, in accordance with point 2.2.2.(c), and which have been slaughtered for human consumption;  
(b) animals which have died or been killed on the holding but which 
were not killed in the framework of a disease eradication campaign. 
3.2. Only the following animals ma y be introduced to the holding: 
(a) male ovine animals of the ARR/ARR genotype; (b) female ovine animals carrying at least one ARR allele and no VRQ 
allele; 
(c) caprine animals, provided that a cleaning and disi nfection of all 
animal housing on the premises ha s been carried out following 
destocking. 
3.3. Only the following breeding rams and ovine germinal products may be 
used in the holding: 
(a) male ovine animals of the ARR/ARR genotype;  (b) semen from rams of the ARR/ARR genotype; (c) embryos carrying at least one  ARR allele and no VRQ allele. 
3.4. Movement of animals from the holdi ng shall either be allowed for the 
purposes of destruction, or shall be  subject to the following conditions: 
(a) the following animals may be moved from the holding for all 
purposes, including breeding: 
– ARR/ARR ovine animals ; 
– ewes carrying one ARR allele  and no VRQ allele, provided 
that they are moved to other holdings which are restricted 
following the application of measures in accordance with point 2.2.2.(c) or 2.2.2.(d); 
– caprine animals, provided that they are moved to other 
holdings which are restricted following the application of 
measures in accordance with point 2.2.2.(c) or 2.2.2.(d); EN 22   EN (b) the following animals may be moved from the holding to go 
directly for slaughter for human consumption: 
– ovine animals carrying at least one ARR allele; 
– caprine animals; 
– if the Member State so decide s, lambs and kids less than 
three months old on the date of slaughter; 
– all animals when the Member State has decided to apply the 
derogations laid down in point 2.2.2.(b)(i) and point 
2.2.2.(c)(i); 
(c) if the Member State so decides,  lambs and kids may be moved to 
one other holding located within its territory solely for the purposes 
of fattening prior to slaughter subject to compliance with the 
following conditions:  
– the holding of destination doe s not contain any ovine or 
caprine animals other than t hose being fattened prior to 
slaughter;  
– at the end of the fattening period, the lambs and kids 
originating from the holdings  subject to the eradication 
measures shall be transporte d directly to a slaughterhouse 
located within the territory of the same Member State to be 
slaughtered not later than when  they are twelve months of 
age.  
3.5. The restrictions set out in points 3.1 to 3.4 shall c ontinue to apply to the 
holding: 
(a) until the date of attainment of ARR/ARR status by all ovine 
animals on the holding, provided th at no caprine animals are kept 
on the holding; or 
(b) for a period of two years from the date when all the measures 
referred to in point 2.2.1., point 2.2.2.(b) or point 2.2.2.(c) have 
been completed, provided that no TSE case other than atypical scrapie is detected during this tw o-year period. If a case of atypical 
scrapie is confirmed du ring this two-year period the holding shall 
also be subject to the measur es referred to in point 2.2.3. 
4. Following the decision to implement option 3  laid down in point 2.2.2.(d) or 
the derogation provided for in point 2.2.2.( c)(iii), the following measures shall 
immediately apply to the holding: 
4.1. The holding shall be subjected to an  intensified TSE monitoring protocol 
including the testing for the presence of TSE in accordance with the laboratory methods and prot ocols set out in Annex X, Chapter C, Part 3, EN 23   EN point 3.2, of all of the following animals which are over the age of 18 
months, except ovine animal s of the ARR/ARR genotype: 
(a) animals which have been slaughtered for human consumption;  (b) animals which have died or been killed on the holding but which 
were not killed in the framework of a disease eradication campaign. 
4.2. Only the following ovine animals may be introduced to the holding: 
(a) male ovine animals of the ARR/ARR genotype; (b) female ovine animals carrying at least one ARR allele and no VRQ 
allele. 
However, by way of derogation from points (a) and (b), a Member State 
may allow the animals referred to in points (c) and (d) to be introduced to the holding where the breed reared in the holding is listed by the Member State as a local breed in danger of being lost to farming in accordance 
with Annex IV to Commission Re gulation (EC) No 1974/2006 (**), and 
where the frequency of the ARR allele within the breed is low: 
(c) male ovine animals carrying at least one ARR allele and no VRQ 
allele; 
(d) female ovine animals carrying no VRQ allele. 
4.3. Only the following breeding rams and ovine germinal products may be 
used in the holding: 
(a) male ovine animals of the ARR/ARR genotype; (b) semen from rams of the ARR/ARR genotype; (c) embryos carrying at least one  ARR allele and no VRQ allele. 
However, by way of derogation from points (a), (b) and (c), a Member 
State may allow the breeding rams and ovine germinal products referred to in points (d), (e) and (f) to be  used in the holdi ng where the breed 
reared in the holding is listed by the Member State as a local breed in 
danger of being lost to farming in accordance with Annex IV to 
Commission Regulation (E C) No 1974/2006, and wher e the frequency of 
the ARR allele within the breed is low: 
(d) male ovine animals carrying at least one ARR allele and no VRQ 
allele; 
(e) semen from male ovine animals carrying at least one ARR allele 
and no VRQ allele; 
(f) embryos carrying no VRQ allele. EN 24   EN 4.4. Movement of animals from the holding shall be allowed for the purposes 
of destruction, or shall be subj ect to the following conditions: 
(a) rams and ewes of the ARR/ARR genotype may be moved from the 
holding for all purposes, including br eeding, provided that they are 
moved to other holdings which are subject to the application of 
measures in accordance with point 2.2.2.(c) or 2.2.2.(d); 
(b) the following animals may be moved from the holding to go 
directly for slaughter for human consumption: 
– either ovine animals carrying at  least one ARR allele and, if 
the Member State so decides, lambs and kids less than three 
months old on the da te of slaughter; 
– or all animals when the Member State has decided to apply 
the derogation from option 2 laid down in point 2.2.2.(c)(iii) or option 3 laid down in point 2.2.2.(d). 
(c) if the Member State so decides,  lambs and kids may be moved to 
one other holding located within its territory solely for the purposes 
of fattening prior to slaughter subject to compliance with the 
following conditions:  
– the holding of destination sh all not contain any ovine or 
caprine animals other than t hose being fattened prior to 
slaughter;  
– at the end of the fattening period, the lambs and kids 
originating from the holdings  subject to the eradication 
measures shall be transporte d directly to a slaughterhouse 
located within the territory of the same Member State to be 
slaughtered not later than when  they are twelve months of 
age. 
4.5. Movement of germinal products from  the holding shall be subject to the 
following conditions: the Member Stat e shall ensure that no semen, 
embryo and ova are dispat ched from the holding. 
4.6. Common grazing of all ovine and cap rine animals in the holding with 
ovine and caprine animals of other holdings shall be prohibited during 
the lambing and kidding period.  
Outside of the lambing and kidding  period, common grazing shall be 
subject to restrictions to be determ ined by the Member State, based on a 
reasoned consideration of all the epidemiological factors. 
4.7. The restrictions set ou t in point 2.2.2.(a) and in points 4.1 to 4.6 shall 
continue to apply for a period of tw o years following the detection of the 
last TSE case, other than atypical sc rapie, on the holdi ngs where option 3 
laid down in point 2.2.2.(d) has been implemented. If a case of atypical EN 25   EN scrapie is confirmed during this two- year period the holding shall also be 
subject to the measures referred to in point 2.2.3. 
In holdings where the derogation fr om option 2 provided for in point 
2.2.2.(c)(iii) has been implemented, th e restrictions set out in point 
2.2.2.(a) and in points 4.1 to 4.6 shall apply until the complete 
destruction or slaughtering for hum an consumption of the animals 
identified for killing in accordance with point 2.2.2.(c), after which the 
restrictions laid out in po int 3 shall be applicable. 
CHAPTER C 
MINIMUM REQUIREMENTS FOR A BREEDING PROGRAMME FOR 
RESISTANCE TO TSES IN OVIN E ANIMALS IN AC CORDANCE WITH 
ARTICLE 6A 
PART 1  
General requirements  
1. The breeding programme sha ll concentrate on flocks of  high genetic merit, as 
defined in point 3 of Annex I of Commission Decision 2002/1003/EC (12). 
However, Member States where a breeding programme is in place may decide 
to allow sampling and genotyping of breeding rams only, in flocks not participating in the breeding programme. 
2. A database shall be established containi ng at least the following information:  
(a) the identity, breed and number of animals in all flocks participating in the 
breeding programme; 
(b) the identification of the indivi dual animals sampled under the breeding 
programme, including breeding rams samp led in flocks not participating 
in the breeding programme;  
(c) the results of any genotyping tests.  
3. A system of uniform certification shall be established in which the genotype of 
each animal sampled under the breeding programme, including breeding rams sampled in flocks not participating in  the breeding programme, is certified by 
reference to its individual  identification number.  
4. A system for the identification of animals and samples, the processing of 
samples and the delivery of results sh all be established which minimises the 
possibility of human error. The effectiven ess of that system shall be subject to 
regular random checking.  
5. Genotyping of blood or other tissues coll ected for the purposes of the breeding 
programme, including from breeding rams sampled in flocks not participating 
                                                
 
12 OJ L 349, 24.12.2002, p. 105. EN 26   EN in the breeding programme, shall be carried  out in laboratories that have been 
approved under the breeding programme.  
6. The competent authority of the Member State may assist breed societies, to 
establish genetic banks consisting of se men, ova and embryos representative of 
prion protein genotypes whic h are likely to become rare as a result of the 
breeding programme.  
7. Breeding programmes shall be drawn up for each breed, taking account of:  
(a) frequencies of the different  alleles within the breed;  
(b) rarity of the breed;  (c) avoidance of inbreedi ng or genetic drift.  
PART 2  
Specific rules for participating flocks  
1. The breeding programme shall be aime d at increasing the frequency of the 
ARR allele within the flock, while reduc ing the prevalence of those alleles 
which have been shown to contri bute to susceptibility to TSEs.  
2. The minimum requirements for participat ing flocks shall be the following:  
(a) all animals in the flock that are to  be genotyped shal l be individually 
identified using secure means;  
(b) all rams intended for breeding within the flock shall be genotyped before 
being used for breeding;  
(c) any male animal carrying the VR Q allele shall be slaughtered or 
castrated, within six months following the determination of its genotype; any such animal shall not leave the holding except for slaughter;  
(d) female animals that are known to ca rry the VRQ allele shall not leave the 
holding except for slaughter;  
(e) male animals, including semen don ors used for artificial insemination, 
other than those certified under the breeding programme, shall not be 
used for breeding within the flock.  
3. Member States may decide to grant de rogations from the requirements set out 
in point 2(c) and (d) for the purposes of  the protection of breeds and production 
traits.  
4. Member States shall inform the Co mmission of any derogation granted under 
point 3 and of the criteria used. 
PART 3  EN 27   EN Specific rules for breeding rams sampled in  flocks not participating in the breeding 
programme 
1. Rams to be sampled shall be individu ally identified using secure means. 
2. Any ram found to carry the VRQ allele shall not leave the holding except for 
slaughter.  
PART 4  
The framework for the recognition of the TS E-resistant status of flocks of ovine 
animals  
1. The framework for the recognition of th e TSE-resistant status of flocks of 
ovine animals shall recognise the TSE-re sistant status of flocks of ovine 
animals that as a result of participation in the br eeding programme as provided 
for in Article 6a, satisfy the crite ria required in that programme.  
That recognition shall be granted on at least the following two levels:  
(a) level I flocks shall be flocks comp osed entirely of ovi ne animals of the 
ARR/ARR genotype;  
(b) level II flocks shall be flocks whose progeny have been sired exclusively 
by rams of the ARR/ARR genotype. 
Member States may decide to grant recognition on further levels to suit 
national requirements.  
2. Regular random sampling of ovine animal s from TSE-resistant flocks shall be 
carried out:  
(a) on the holding or at the slaughter house to verify their genotype;  
(b) in the case of level I flocks, in animals over 18 months of age at the 
slaughterhouse, for TSE testing in accordance with Annex III.  
PART 5  
Reports to be provided to the Commission by the Member States  
Member States introducing national breeding programmes to select for resistance to 
TSE in their ovine populations shall: 
1. notify to the Commission the requ irements for such programmes;  
2. submit to the Commission an a nnual report on their progress.  
The report for each calendar year shall be s ubmitted at the latest by 31 March of the 
following year. 
(*) OJ L 300, 14.11.2009, p. 1. EN 28   EN (**) OJ L 368, 23.12.2006, p. 15.' EN 29   EN (4) In Annex VIII, Chapter A is replaced by the following: 
'CHAPTER A 
Conditions for intra-Union trade in live animals, semen and embryos 
SECTION A  
Conditions which apply to ovine and caprine animals and semen and embryos 
thereof 
1. Holdings with a negligible risk of cl assical scrapie and a controlled risk of 
classical scrapie: 
1.1. Member States may establish or supervise an official scheme for the 
recognition of holdings with  a negligible risk of  classical scrapie and 
holdings with a controlled risk  of classical scrapie.  
When they do so, they shall maintain a list of holdings of ovine and 
caprine animals with a negligible risk  and holdings with a controlled risk 
of classical scrapie. 
1.2. A holding of ovine animals having the TSE-resistance level I status, as 
laid down in Annex VII, Chapter C, Part 4, point 1.(a), and where no case 
of classical scrapie has been confir med for at least seven years may be 
recognised as having a negligible  risk of classical scrapie. 
A holding of ovine animals, caprine animals, or ovine and caprine 
animals may also be recognised as havi ng a negligible ri sk of classical 
scrapie provided that it has complied with the following conditions for at 
least seven years: 
(a) ovine and caprine animals are permanently identified and records 
are maintained, to enable them to be traced back to their holding of birth;  
(b) records of movements of ovine a nd caprine animals in and out of 
the holding are maintained;  
(c) only the following ovine and capri ne animals may be introduced: 
(i) ovine and caprine animals from  holdings with a negligible 
risk of classical scrapie; 
(ii) ovine and caprine animals fr om holdings which have met the 
conditions laid down in points (a) to (i) for a minimum of 
seven years or for at least th e same period of time as the 
holding where they are to be introduced; 
(iii) ovine animals of the A RR/ARR prion protein genotype. EN 30   EN (d) the holding is subject to regular ch ecks to verify compliance with 
the provisions set out in point (a) to (i) by an official veterinarian or 
a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an a nnual basis from 
1 January 2014;  
(e) no case of classical scrapi e has been confirmed;  
(f) all ovine and caprine animals over 18 months of age slaughtered 
for human consumption are inspected  by an official veterinarian, 
and all those exhibiting wasting sign s, neurological signs or sent 
for emergency slaughter are tested in a laboratory for classical scrapie in accordance with the la boratory methods and protocols set 
out in Annex X, Chapter C, Part 3, point 3.2. 
Until 31 December 2013, all ovine and caprine animals referred to 
in Annex III, Chapter A, Part II, poi nt 3 over 18 months of age that 
have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie 
in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.  
From 1 January 2014, all ovine and caprine animals over 18 
months of age that have died or have been killed for reasons other 
than slaughter for human consum ption shall be tested in a 
laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. 
In addition to the condi tions set out in points (a) to (f), the following 
conditions shall be complied with from 1 January 2014: 
(g) only the following ovine and capri ne embryos/oocytes may be 
introduced: 
(i) embryos/oocytes from donor an imals which have been kept 
since birth in a Member State with a negligible risk of 
classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which meet the 
following requirements: 
− 
 
− 
 
 
− they are permanently identifie d to enable trace back to 
their holding of birth; 
they have been kept since bi rth in holdings  in which no 
case of classical scrapie has been confirmed during 
their residency; 
they showed no clinical sign of classical scrapie at the 
time of embryo/oocyte collection; EN 31   EN (ii) ovine embryos/oocytes of  the ARR/ARR prion protein 
genotype.  
(h) only the following ovine and cap rine semen may be introduced: 
(i) semen from donor animals which have been kept since birth 
in a Member State with a negligib le risk of classical scrapie, 
or in a holding with a negligible  risk or a controlled risk of 
classical scrapie, or which meet the following requirements: 
− 
 
− they are permanently identifie d to enable trace back to 
their holding of birth; 
they showed no clinical sign of classical scrapie at the 
time of semen collection; 
(ii) ovine semen from a ram of the ARR/ARR prion protein 
genotype; 
(i) ovine and caprine animals on the hold ing have no direct or indirect 
contact, including sharing grazing, with ovine and caprine animals 
from holdings of a lower status. 
1.3. A holding of ovine and/or caprine an imals may be recognised as having a 
controlled risk of classical scrapie pr ovided that it has complied with the 
following conditions for a period of at least three years: 
(a) ovine and caprine animals are permanently identified and records 
are maintained, to enable them to be traced back to their holding of birth;  
(b) records of movements of ovine a nd caprine animals in and out of 
the holding are maintained;  
(c) only the following ovine and capri ne animals may be introduced: 
(i) ovine and caprine animals from  holdings with a negligible or 
a controlled risk of classical scrapie; 
(ii) ovine and caprine animals fr om holdings which have met the 
conditions laid down in points (a) to (i) for a minimum of 
three years or for at least th e same period of time as the 
holding where they are to be introduced; 
(iii) ovine animals of the A RR/ARR prion protein genotype. 
(d) the holding is subject to regular ch ecks to verify compliance with 
the provisions set out in point (a) to (i) by an official veterinarian or 
a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an a nnual basis from 
1 January 2014;  EN 32   EN (e) no case of classical scrapi e has been confirmed;  
(f) all ovine and caprine animals over 18 months of age slaughtered 
for human consumption are inspected  by an official veterinarian, 
and all those exhibiting wasting sign s, neurological signs or sent 
for emergency slaughter are tested in a laboratory for classical scrapie in accordance with the la boratory methods and protocols set 
out in Annex X, Chapter C, Part 3, point 3.2. 
Until 31 December 2013, all ovine and caprine animals referred to 
in Annex III, Chapter A, Part II, poi nt 3 over 18 months of age that 
have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie 
in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2.  
From 1 January 2014, all ovine and caprine animals over 18 
months of age that have died or have been killed for reasons other 
than slaughter for human consum ption shall be tested in a 
laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, Part 3, point 3.2. 
In addition to the condi tions set out in points (a) to (f), the following 
conditions shall be complied with from 1 January 2014: 
(g) only the following ovine and capri ne embryos/oocytes may be 
introduced: 
(i) embryos/oocytes from donor an imals which have been kept 
since birth in a Member State with a negligible risk of 
classical scrapie, or in a holding with a negligible risk or with 
a controlled risk of classica l scrapie, or which meet the 
following requirements: 
− 
 
− 
 
 
− they are permanently identifie d to enable trace back to 
their holding of birth; 
they have been kept since bi rth in holdings  in which no 
case of classical scrapie has been confirmed during 
their residency; 
they showed no clinical sign of classical scrapie at the 
time of embryo/oocyte collection; 
(ii) ovine embryos/oocytes of  the ARR/ARR prion protein 
genotype. 
(h) only the following ovine and cap rine semen may be introduced: 
(i) semen from donor animals which have been kept since birth 
in a Member State with a negligib le risk of classical scrapie, EN 33   EN or in a holding with a negligible risk or with a controlled risk 
of classical scrapie, or which meet the following requirements: 
− 
 
− they are permanently identifie d to enable trace back to 
their holding of birth; 
they showed no clinical sign of classical scrapie at the 
time of semen collection; 
(ii) ovine semen from a ram of the ARR/ARR prion protein 
genotype;  
(i) ovine and caprine animals of the hold ing have no direct or indirect 
contact, including sharing grazing, with ovine and caprine animals 
from holdings of lower status. 
1.4. If a case of classical scrapie is conf irmed in a holding with a negligible 
risk or a controlled risk of classica l scrapie, or in a holding found to have 
an epidemiological link to a holding with  a negligible risk or a controlled 
risk of classical scrapie as  a result of an inquiry referred to in Part 1 of 
Chapter A of Annex VII, the holdi ng with a negligib l e  r i s k  o r  a  
controlled risk of classi cal scrapie shall be imme diately deleted from the 
list referred to in point 1.1.  
The Member State shall immediately inform the other Member States 
which have imported ovine and caprine  animals originating from that 
holding during the last seven years in  the case of a holding with a 
negligible risk or during the last thre e years in the case of a holding with 
a controlled risk. 
2. Member States or zones of a Member St ate with a negligible risk of classical 
scrapie 
2.1. Where a Member State considers that its  territory or part  of its territory 
poses a negligible risk of classical scrapie, it shall submit to the Commission appropriate  supporting documentation, setting out in 
particular that: 
(a) a risk assessment has been conducte d, and it has demonstrated that 
appropriate measures are currently in place and have been taken for 
the relevant period of time to manage any risk identified. This risk assessment shall identify all potenti al factors for classical scrapie 
occurrence and their historic pers pective, in particular the: 
(i) importation or introduction of ovine and caprine animals or 
their semen and embryos potentia lly infected with classical 
scrapie; 
(ii) extent of knowledge of the population structure and 
husbandry practices of ovine and caprine animals; EN 34   EN (iii) feeding practices, including consumption of meat-and-bone 
meal  or greaves  derived from ruminants; 
(iv) importation of milk and milk products  of ovine and caprine 
animals origin intended for use in feeding of ovine and caprine animals; 
(b) for a period of at least seven years, ovine and caprine animals 
displaying clinical signs compatible with classical scrapie have been tested; 
(c) for a period of at least seven ye ars, a sufficient number of ovine 
and caprine animals over 18 months  of age, representative of 
slaughtered, culled or found dead  on farm, have been tested 
annually, to provide a 95 percent level of confidence of detecting 
classical scrapie if it is present in that population at a prevalence 
rate exceeding 0,1 percent and no case of classical scrapie has been reported during that period;  
(d) the feeding to ovine and caprine animals of meat-and-bone meal or 
greaves of ruminant origin ha s been banned and effectively 
enforced in the whole Member Stat e for a period of at least seven 
years;  
(e) introductions from other Member  States of ovine and caprine 
animals and semen and embryos thereof are carried out in accordance with point 4.1.(b) or point 4.2.;  
(f) introductions from third countries of ovine and caprine animals and 
semen and embryos thereof are carried out in accordance with Chapter E or Chapter H of Annex IX. 
2.2. The negligible risk status for classi cal scrapie of the Member State or of 
the zone of the Member State may be approved in accordance with the 
procedure referred to in Article 24(2).  
The Member State is to notify the Commission of any change in the 
information submitted according to point 2.1. relating to the disease. 
The negligible risk status approved in accordance with point 2.2. may, in 
the light of such notification, be withdrawn in accordance with the 
procedure referred to in Article 24(2).  
3. National control programme  for classical scrapie: 
3.1. a Member State which has a nationa l control programme for classical 
scrapie covering all of its territory: 
(a) may submit its national control programme to the Commission, 
outlining in particular: 
– the distribution of classical sc rapie in the Member State, EN 35   EN – the reasons for national control programme, taking into 
consideration the importance of the disease and the cost/benefit ratio, 
– the status categories defined fo r holdings and the standards 
which must be attained in each such category, 
– the test procedures to be used, 
– the national control progra mme 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 national control programme programme are positive, 
(b) the programme referred to in point (a) 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); amendments or 
additions to the programmes sub mitted by Member States may be 
approved in accordance with the pr ocedure referred to in Article 
24(2). 
3.2. The national scrapie control programm es of following Member States are 
hereby approved: 
– Denmark 
– Austria 
– Finland 
– Sweden. 
4. Intra-Union trade in ovine  and caprine animals and semen and embryos thereof 
The following conditions shall apply: 
4.1. ovine and caprine animals: 
(a) ovine and caprine animals for br eeding intended for Member States 
other than those with a negligible risk of classical scrapie or with 
an approved national scrapie control programme shall: 
(i) come from a holding or holdings  with a negligible risk or a 
controlled risk of classical scrapie; however ovine and 
caprine animals for breeding coming from a holding or holdings which have complied with all the requirements laid down in point 1.3. (a) to (f), for a period of at least three 
years may be subject to intr a-Union trade until 31 December 
2014; or EN 36   EN (ii) come from a Member State or  zone of a Member State with a 
negligible risk of classical scrapie; or 
(iii) in the case of ovine anim als, be of the ARR/ARR prion 
protein genotype, provided they do not come from a holding 
subject to the restrictions laid  down in Annex VII, Chapter B, 
points 3 and 4. 
(b) ovine and caprine animals for all intended use except immediate 
slaughter intended for the Member St ates with a negligible risk of 
classical scrapie or with an approved national scrapie control 
programme shall: 
(i) come from a holding or holdings  with a negligible risk of 
classical scrapie; however ovi ne and caprine animals for 
breeding coming from a holding or holdings which complied with all the requirement s laid down in point 1.2. (a) to (i), for 
a period of at least seven years may be subject to intra-Union 
trade until 31 December 2014; or 
(ii) come from a Member State or  zone of a Member State with a 
negligible risk of classical scrapie; or 
(iii) in the case of ovine anim als, be of the ARR/ARR prion 
protein genotype, provided they do not come from a holding 
subject to the restrictions laid  down in Annex VII, Chapter B, 
points 3 and 4. 
4.2. semen and embryos of ovine and caprine animals shall: 
(a) be collected from animals which have been kept continuously since 
birth on a holding or holdings with a negligible risk or a controlled 
risk of classical  scrapie; or 
(b) be collected from animals which have been kept continuously for 
the last three years before the co llection on a holding or holdings 
which have complied with all the requirements laid down in Part 1, point 1.3. (a) to (f) for three years; or 
(c) be collected from animals which have been kept continuously since 
birth in a country or zone with a negligible risk of classical scrapie; or  
(d) in the case of ovine semen, be collected from male animals of the 
ARR/ARR prion prot ein genotype; or 
(e) in the case of ovine embryos, be of the ARR/ARR prion protein 
genotype. EN 37   EN SECTION B  
Conditions which apply to bovine animals 
The United Kingdom shall ensure that bovine animals born or reared on its territory 
before 1 August 1996 are not dispatched from its territory to other Member States or 
third countries.' EN 38   EN (5) Annex IX is amended as follows: 
(a) In Chapter C, Section A is  replaced by the following:  
'SECTION A 
Products  
The following products of bovine, ovine and caprine origin, as defined by 
points 1.10, 1.13, 1.15, 7.1, 7.5, 7.6, 7.7, 7.8 and 7.9 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council, shall be subject to the conditions laid down in Sections B, C and D of this Chapter depending on the BSE risk category of the country of origin: 
– fresh meat, 
– minced meat,  
– meat preparations, 
– meat products, 
– rendered animal fat, 
– greaves, 
– gelatine and collagen other than derived from hides and skins, 
– treated intestines.' 
(b) Chapters D and E are replaced by the following: 
'CHAPTER D  
Imports of animal by-products and d erived products from bovine, ovine 
and caprine origin 
SECTION A 
Animal by-products 
This Chapter shall apply to the following animal by-products and derived 
products, as defined in points (1) and (2) of Article 3 of Regulation (EC) 
No 1069/2009 of the European Parliament and of the Council, provided that 
those products are of bovine, ovine  and caprine animal origin: 
(a) Rendered fats derived from Category 2 material, which are intended to be 
used as organic fertilisers or soil improvers, as defined in point 22 of 
Article 3 of Regulation (EC) No 1069/ 2009, or their starting materials or 
intermediate products; 
(b) Bones and bone products deri ved from Category 2 material; EN 39   EN (c) Rendered fats derived from Category 3 material which are intended to be 
used as organic fertilisers or soil imp rovers or as feed, as defined in 
points 22 and 25 of Article 3 of Re gulation (EC) No 1069/2009, or their 
starting materials or intermediate products; 
(d) Pet food including dog chews; (e) Blood products; (f) Processed animal protein; (g) Bones and bone products deri ved from Category 3 material; 
(h) Gelatine and collagen derived from ma terials other than hides and skins; 
(i) Category 3 material and derived products other th an those referred to in 
points (c) to (h) excluding: 
(i) fresh hides and skins, treated hides and skins;  (ii) gelatine and collagen de rived from hides and skins; 
(iii) fat derivatives. 
SECTION B 
Health certificate requirements 
Imports of the animal by-products a nd derived products of  bovine, ovine and 
caprine origin referred to in Section A shall be subject to the presentation of a health certificate which has been comple ted with the following attestation: 
(a) the animal by-product or derived product does not contain and is not 
derived from specified risk material or mechanically separated meat obtained from bones of bovine, ovine or  caprine animals and, except for 
animals born, continuously reared and slaughtered in a country or region 
classified as posing a negligible BS E risk by a decision in accordance 
with Article 5(2), the animals from  which this animal by-product or 
derived product is derived, have not been slaughtered after stunning by 
means of gas injected into the cran ial cavity or killed by the same method 
or slaughtered by laceration of cent ral nervous tissue by means of an 
elongated rod-shaped instrument intr oduced into the cranial cavity; or 
(b) the animal by-product or derived product does not contain and is not 
derived from bovine, ovine and capri ne materials other than those 
derived from animals born, continuous ly reared and slaughtered in a 
country or region classified as posing a negligible BSE risk by a decision 
in accordance with Article 5(2). 
In addition to points (a) and (b), imports  of the animal by-products and derived 
products referred to in Section A, contai ning milk or milk products of ovine or EN 40   EN caprine animal and intended for feed, sha ll be subject to the presentation of a 
health certificate which has been comple ted with the following attestation: 
(c) the ovine and caprine animals fr om which those products are derived 
have been kept continuously since birth in a country where the following conditions are fulfilled: 
(i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) official restrictions apply to ho ldings of ovine or caprine animals in 
case of a suspicion of TSE or a c onfirmation of classical scrapie; 
(iv) ovine and caprine animals affected  with classical scrapie are killed 
and completely destroyed; 
(v) the feeding to ovine and caprine  animals of meat-and-bone meal or 
greaves of ruminant origin ha s been banned and effectively 
enforced in the whole country for a period at least seven years; 
(d) the milk and milk products of ov ine or caprine animals derive from 
holdings where no official restrictio n is imposed due to a suspicion of 
TSE; 
(e) the milk and milk products of ov ine or caprine animals derive from 
holdings where no case of classical scrapie has been diagnosed for the 
last seven years or, following the c onfirmation of a case of classical 
scrapie: 
(i) all ovine and caprine animals on the holding have been killed and 
destroyed or slaughtered, excep t for breeding rams of the 
ARR/ARR genotype, breeding ewes  carrying at least one ARR 
allele and no VRQ allele and othe r ovine animals carrying at least 
one ARR allele; or 
(ii) all animals in which classica l scrapie was conf irmed have been 
killed and destroyed, and the ho lding has been s ubjected for two 
years at least since the confirmation of the last classical scrapie case to intensified TSE monitoring, including testing with negative 
results for the presence of TSE in accordance with the laboratory 
methods set out in Annex X, Chapter C, point 3.2, of all of the following animals which are over the age of 18 months, except ovine animals of the ARR/ARR genotype: 
– animals which have been slaughtered for human 
consumption; and 
– animals which have died or been killed on the holding but 
which were not killed in the framework of a disease eradication campaign. EN 41   EN CHAPTER E 
Imports of ovine and caprine animals  
Ovine and caprine animals imported into the Union are to be subject to the 
presentation of an animal health certificate attesting that they have been kept 
continuously since birth in a country  where the following conditions are 
fulfilled: 
1. classical scrapie is compulsorily notifiable; 2. an awareness, surveillance and monitoring system is in place; 3. ovine and caprine animals affected w ith classical scrapie are killed and 
completely destroyed; 
4. the feeding to ovine and caprine animals of meat-and-bone meal or 
greaves of ruminant origin has been  banned and effectively enforced in 
the whole country for a period of at least seven years; 
In addition to the conditions set out in Pa rts 1 to 4, the animal health certificate 
shall attest that: 
5. For ovine and caprine animals for breeding imported into the Union and 
intended for Member States other than those with a negligible risk of classical scrapie or those with an  approved national scrapie control 
programme listed in point 3.2 of Sec tion A of Chapter A of Annex VIII, 
the following conditions shall be complied with:  
– the imported ovine and caprine an imals come from a holding or 
holdings that have complied with  the conditions of point 1.3 of 
Section A of Chapter A of Annex VIII; or  
– they are ovine animals of the ARR/ARR prion protein genotype 
and they come from a holding where no official movement 
restriction has been imposed due to  BSE or classical scrapie during 
the last two years. 
6. For ovine and caprine animals for a ll uses except immediate slaughter 
imported into the Union and intended for a Member State with a negligible risk of classical scrapie or with an approved national scrapie 
control programme listed in point 3.2 of Section A of Chapter A of 
Annex VIII, the following conditions shall be complied with:  
– they come from a holding or holdings that have complied with the 
conditions of point 1.2 of Section A of Chapter A of Annex VIII; or  
– they are ovine animals of the ARR/ARR prion protein genotype 
and they come from a holding where no official movement 
restriction has been imposed due to  BSE or classical scrapie during 
the last two years.' EN 42   EN (c) Chapter H is replaced by the following: 
'CHAPTER H 
Import of ovine and caprine semen and embryos  
Ovine and caprine semen and embryos imported into the Union are to be 
subject to the presentation of an animal health certificate attesting that the donor animals: 
1. have been kept continuously since birth in a country where the following 
conditions are fulfilled: 
(i) classical scrapie is compulsorily notifiable; (ii) an awareness, surveillance and monitoring system is in place; (iii) ovine and caprine animals affected  with classical sc rapie are killed 
and completely destroyed; 
(iv) the feeding to ovine and caprine  animals of meat-and-bone meal, or 
greaves of ruminant origin ha s been banned and effectively 
enforced in the whole country for a period of at least seven years; 
2. have been kept continuously for the last three years before the collection 
of the exported semen or embryos in  a holding or holdings which have 
been satisfying for the last three year s at least all the requirements laid 
down in point 1.3. (a) to (f) of Sectio n A of Chapter A of Annex VIII, or: 
(i) in the case of ovine semen, the se men has been collected from male 
animals of the ARR/ARR prion protein genotype. 
(ii) in the case of ovine embryos , the embryos are of the ARR/ARR 
prion protein genotype.' EN 43   EN (6) In Annex X, in Chapter C, in Part 3, in  point 3.1, the following point 3.1(c) is added: 
'(c) Further examination of positive BSE cases 
Samples from all positive BSE cases shall be forwarded to a laboratory, 
appointed by the competent authority, wh ich has participated  successfully in 
proficiency testing organised by the Eur opean Union reference laboratory for 
discriminatory testing of confirmed BS E cases, where they shall be further 
tested in accordance with the methods a nd protocols laid down in the European 
Union reference laboratory's method for the classification of bovine TSE 
isolates (*). 
(*) http://vla.defra.gov.uk/scienc e/docs/sci_tse_rl_2blot.pdf'.