COMMI SSION REGUL ATION (EU) 2021/1176 
of 16 July 2021
amending Annex es III, V, VII and IX to Regulation (EC) No 999/2001 of the European Parliament and 
of the Council as regards genotyping of positiv e TSE cases in goats, the deter mination of age in ovine 
and capr ine animals, the measures applicable in a herd or flock with atypical scrapie and the 
conditions for impor ts of products of bovine, ovine and capr ine origin 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng regar d 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 spongif orm encephalopathies (1), and in 
particular the first paragraph of Article 23 and the introduct ory phrase and point (m) of Article 23a thereof,
Whereas:
(1) Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible 
spongif orm encephalopathies (TSEs) in animals. It categor ises Member States, third countr ies or regions thereof, 
depending on their bovine spongif orm encephalopathy (BSE) risk, into those with a negligible BSE risk, a controlled 
BSE risk or an undete rmined BSE risk.
(2) Annex III to Regulation (EC) No 999/2001 lays down rules concer ning a monitori ng system for the prevention of 
TSEs, including the monitor ing of ovine and capr ine animals. Point 8 of Part II of Chapt er A of Annex III to 
Regulation (EC) No 999/2001 provid es for the compul sory genotyping of positive TSE cases in sheep, and an 
oblig ation to immediately repor t to the Commission any TSE case found in a sheep of the ARR/ARR genotype. 
Sheep of the ARR/ARR genotype are considered to be resistant to classical scrapie, and theref ore any case of the 
disease in such a sheep is an unexpected finding whic h requires attention. For this reason it should be immediately 
notified so that it can be subject to further investigat ion.
(3) Regulation (EC) No 999/2001 was amended by Commission Regulation (EU) 2020/772 (2), in accordance with the 
recommendations of the Scientific Opinion of the European Food Safety Author ity (EFSA) of 5 July 2017 on 
Genetic resistance to transmissible spongif orm encephalopathies (TSE) in goats (3), in order to recognise that goats 
can also be genetically resistant to classical scrapie strains known to occur naturally in the Union’s goat population, 
when they have the K222, D146 or S146 alleles. Regulation (EU) 2020/772 amended Annex VII to Regulation (EC) 
No 999/2001 by introducing rules restr icting the killing and destr uction of capr ine animals, in a herd where a case 
of classical scrapie has been conf irmed, to only those whic h are suscept ible to this disease. However , the 
amendments made to Annex VII to Regulation (EC) No 999/2001 by Regulation (EU) 2020/772 did not cover the 
genotyping of positive TSE cases in goats. Point 8 of Part II of Chapt er A of Annex III and point 8 of Part I.A of 
Chapt er B of Annex III should theref ore be amended to provide for an appropr iate monitoring and repor ting of the 
genotype of positive TSE cases in goats.
(4) In addition, Regulation (EC) No 999/2001 lays down rules concer ning specified risk mater ial, and provid es, inter 
alia, that specified risk mate rial is to be removed and disposed of in accordance with Annex V theret o and with 
Regulation (EC) No 1069/2009 of the European Parliament and of the Council (4). More particularly , point 1(b) of 
(1)OJ L 147, 31.5.2001, p. 1.
(2)Commission Regulation (EU) 2020/772 of 11 June 2020 amending Annex es I, VII and VIII to Regulation (EC) No 999/2001 of the 
European Parliament and of the Council as regar ds eradication measures for transmissible spongif orm encephalopathies in goats and 
endang ered breeds (OJ L 184, 12.6.2020, p. 43).
(3)EFSA Journal 2017;15(8):4962.
(4)Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards 
animal by-products and derived products not intended for human consump tion and repealing Regulation (EC) No 1774/2002 (Animal 
by-products Regulation) (OJ L 300, 14.11.2009, p. 1).EN Offi cial Jour nal of the European Union L 256/56                                                                                                                                         19.7.2021  Annex V to Regulation (EC) No 999/2001 defines specified risk mater ial, in ovine and capr ine animals over 12 
months of age, that is to be removed and disposed of in accordance with Annex V thereto and with Regulation (EC) 
No 1069/2009.
(5) Due to the specificity of the farming of ovine and capr ine animals, the determination of the exact date of birth of 
ovine and capr ine animals is rarely feasible and thus such data is not included in the holding register required in 
accordance with Council Regulation (EC) No 21/2004 (5). Theref ore, prior to the amendment of Annex V to 
Regulation (EC) No 999/2001 by Commission Regulation (EU) 2018/969 (6), the remo val of specified risk mat erial 
was required in ovine and capr ine animals aged over 12 months or in ovine and capr ine animals with a permanent 
incisor erupted through the gum.
(6) Regulation (EU) 2018/969 amended Annex V to Regulation (EC) No 999/2001 by adding the possibility to use a 
method appro ved by the compet ent author ity of the Member State of slaughter to identify ovine and capr ine 
animals aged over 12 months. That possibility was added in 2018 but since that amendment no Member State has 
availed of it. Also, that possibility was intende d to be only applied in the Member States and not to be extended to 
third countr ies. According ly, in the interests of legal certainty and clarity, it is now appropr iate to delete it. 
Theref ore, the possibility to use a method approved by the compet ent author ity of the Member State of slaughter to 
identify ovine and capr ine animals aged over 12 months should be deleted from point 1(b) of Annex V to Regulation 
(EC) No 999/2001.
(7) Annex VII to Regulation (EC) No 999/2001 lays down measures for the control and eradication of TSEs, including 
atypical scrapie. In particular , Chapt er B of that Annex lays down the measures to be applied follo wing 
conf irmation of the presence of a TSE in bovine, ovine and capr ine animals. Commission Regulation (EU) 
No 630/2013 (7)amended Annex VII to Regulation (EC) No 999/2001 in order to lift all restr iction measures on 
the mov ement of ovine and capr ine animals where a case of atypical scrapie has been confir med, but maintained an 
increased surveillance for two years in those flocks or herds in order to gather more scientific data on atypical 
scrapie. Since the date of adoptio n of Regulation (EU) No 630/2013 a signif icant amount of data has been collected. 
The measure laid down in point 2.2.3 of Chapt er B of Annex VII to Regulation (EC) No 999/2001, which is not 
relat ed to public health concer ns, should theref ore now be delet ed.
(8) Chapt er C of Annex IX to Regulation (EC) No 999/2001 lays down the requirements for the importation into the 
Union of products of bovin e, ovine and capr ine animals. These requirements vary according to the BSE status of the 
countr y or region of origin of the products, as well as according to the BSE status of the countr y or region of origin 
of the animals from which the products were derived. The BSE status of countr ies or regions according to their BSE 
risk is set out in Commission Decision 2007/453/EC (8), whic h lists the countr ies or regions with a negligible BSE 
risk and with a controlled BSE risk, and provid es that all other countr ies or regions are to be rega rded as having an 
undeterm ined BSE risk.
(9) Specifi c requirements are laid down in points (g) and (h) of Section B of Chapt er C of Annex IX to Regulation (EC) 
No 999/2001, to address the case of the impor tation of products from a countr y or region with a negligible BSE 
risk derived from animals originating from a countr y or region with an undete rmined BSE risk: point (g) establishes 
that the animals must not have been fed with meat-and-bone meal or greaves; and point (h) establishes that the 
products must have been produced and handled in a manner which ensures that they did not contain and were not 
contaminated with nervous and lymphatic tissues exposed during the deboning process.
(5)Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identif ication and registration of ovine and 
capr ine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).
(6)Commission Regulation (EU) 2018/969 of 9 July 2018 amending Annex V to Regulation (EC) No 999/2001 of the European 
Parliament and of the Council as regar ds the requirements for the removal of specified risk mat erials from small ruminants (OJ L 174, 
10.7.2018, p. 12).
(7)Commission Regulation (EU) No 630/2013 of 28 June 2013 amending the Annexes to Regulation (EC) No 999/2001 of the European 
Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongif orm 
encephalopathies (OJ L 179, 29.6.2013, p. 60).
(8)Commission Decision 2007/453/EC of 29 June 2007 establishing the BSE status of Member States or third countr ies or regions 
thereof according to their BSE risk (OJ L 172, 30.6.2007, p. 84).EN Offi cial Jour nal of the European Union 19.7.2021                                                                                                                                         L 256/57  (10) The specific requirements laid down in points (g) and (h) of Section B of Chapt er C of Annex IX to Regulation (EC) 
No 999/2001 are consistent with the requirements laid down in points 1(a) and 1(c)(ii) of Section D of that Chapt er, 
for the direct importation into the Union from a countr y or region with an undeterm ined BSE risk. Howe ver, those 
specifi c requirements are not currently laid down in Section C of Chapt er C of Annex IX to Regulation (EC) 
No 999/2001, whic h lays down the requirements for impor ts from a countr y or region with a controlled BSE risk. 
Consequently , it is currently permitted, by reason of that unintentional omission, to import into the Union, from a 
countr y or region with a controlled BSE risk, products derived from animals originating from a countr y or region 
with an undeterm ined BSE risk which do not compl y with those specific requirements. The specifi c requirements 
laid down in points (g) and (h) of Section B of Chapt er C of Annex IX to Regulation (EC) No 999/2001 should 
theref ore be inser ted in Section C of Chapt er C of that Annex.
(11) Annex es III, V, VII and IX to Regulation (EC) No 999/2001 should theref ore be amended according ly.
(12) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGUL ATION:
Article 1
Annex es III, V, VII and IX to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 July 2021 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 256/58                                                                                                                                         19.7.2021  ANNEX 
Annex es III, V, VII and IX to Regulation (EC) No 999/2001 are amended as follows:
(1) Annex III is amended as follows :
(a) in Chapt er A, in Part II, point 8 is replaced by the followi ng:
‘8. Genotyping
8.1. The prion prot ein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE 
case in sheep. TSE cases found in sheep of genotypes whic h encode alanine (A) on both alleles at codon 
136, arginine (R) on both alleles at codon 154 and arginine (R) on both alleles at codon 171 shall 
immediately be repor ted to the Commission. Where the positive TSE case is an atypical scrapie case the 
prion protein genotype for the codon 141 shall also be determined.
8.2. The prion prote in genotype for the codons 146 and 222 shall be deter mined for each positive TSE case in 
goats. TSE cases found in goats of genotypes which encode serine (S) or aspar tic acid (D) on at least one 
allele at codon 146 and/or lysine (K) on at least one allele at codon 222, shall immediately be repor ted to 
the Commission.’;
(b) in Chapt er B, in Part I.A., point 8 is replaced by the follo wing:
‘8. The genotype, and, where possible, the breed, of each ovine and capr ine animal found positive to TSE and 
sampled in accordance with Chapt er A, Part II, point 8.’;
(2) in Annex V, point 1(b) is replaced by the followi ng:
‘(b) as regards ovine and capr ine animals: the skull, including the brain and eyes, and the spinal cord of animals aged 
over 12 months or which have a permanent incisor erupted through the gum.’;
(3) in Annex VII, Chapt er B is amended as follo ws:
(a) point 2.2.3 is delet ed;
(b) in point 3.5, sub-point (d) is replaced by the followi ng:
‘(d) for a period of two years from the date when all the measures refer red to in point 2.2.1, point 2.2.2(b), or 
point 2.2.2(c) have been compl eted, provi ded that no TSE case other than atypical scrapie is detected during 
this two- year period.’;
(c) point 4.6 is replaced by the following:
‘4.6. The restr ictions set out in points 4.1 to 4.5 shall apply for a period of two years follo wing the detection of the 
last TSE case, other than atypical scrapie, on the holdings where option 3 laid down in point 2.2.2(d) has 
been implemented .’;
(4) in Annex IX, in Chapt er C, in Section C, in point 1, the followi ng sub-points are added:
‘(e) if the animals, from which the products of bovine, ovine and capr ine animal origin were derived, originate from a 
countr y or region classified in accordance with Decision 2007/453/EC as a countr y or region posing an 
undeterm ined BSE risk, the animals have not been fed with meat-and-bone meal or greav es, as defined in the OIE 
Terrestr ial Animal Health Code;
(f) if the animals, from which the products of bovine, ovine and capr ine animal origin were derived, originate from a 
countr y or region classified in accordance with Decision 2007/453/EC as a countr y or region posing an 
undeterm ined BSE risk, the products were produced and handled in a manner which ensures that they did not 
contain and were not contaminated with nervous and lymph atic tissues exposed during the deboning process.’EN Offi cial Jour nal of the European Union 19.7.2021                                                                                                                                         L 256/59  