EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11906/2020  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III, V, VII and IX to Regulation (EC) No 999/2001 of the European 
Parliament and of the Council as regards genotyping of positive TSE cases in goats, the 
determination of age in ovine and caprine animals, the measures applicable in a herd or 
flock with atypical scrapie and the conditions for imports of products of bovine, ovine 
and caprine origin  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III, V, VII and IX to Regulation (EC) No 999/2001 of the European 
Parliament and of the Council  as regards genotyping of positive TSE cases in goats, the 
determination of age in ovine and caprine animals, the measures applicable in a herd or 
flock with atypical scrapie and the conditions for imports of products of bovine, ovine 
and caprine origin  
(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 preve ntion, control and eradication of 
certain transmissible spongiform encephalopathies1, and in particular the first paragraph of 
Article 23 and the introductory 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 spongiform encephalopathies (TSEs)  in animals . It 
categorises Member States, third countries or regions thereof, depending on their 
bovine spongiform (BSE) risk, into those with a negligible BSE  risk, a controlled BSE 
risk or an undetermined BSE risk.  
(2) Annex III to Regulation (EC) No 999/2001 lays down rules concerning a monitoring 
system for the prevention of TSEs, including the monitoring of ovine and caprine 
animals. Point 8 of Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 
provides for the compulsory genotyping of positive TSE cases in sheep, and an 
obligation to immediately report 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 therefore any case of the disease in such a sheep is an 
unexpected  finding  which requires attention . For this reason it should be immediately 
notified so that it can be subject to f urther investigation .  
(3) Regulation (EC) No 999/2001 was amended by Commission Regulation (EU) 
2020/7722, in accordance with the recommendations of the Scientific Opinion of the 
European Food Safety Authority (EFSA) of 5 July 2017  on Genetic resistance to 
transmissible spongiform encephalopathies (TSE) in goats3, 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 
                                                 
1 OJ L 147, 31.5.2001, p. 1. 
2  Commission Regulation (EU) 2020/772 of 11 June 2020 amending Annexes I, VII and VIII to 
Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication 
measures for transmissible spongiform encephalopathies in goat s and endangered breeds  (OJ L 184, 
14.06.2020, p. 43)  
3  EFSA Journal 2017;15(8):4962.  EN 2  EN alleles. Regulation (EU) 2020/772 amended Annex VII to Regulation (EC) No 
999/2001 by introducing rules restricting the killing and destruction of caprine 
animals , in a herd where a case of classical scrapie has been confirmed , to only those 
which are susceptible 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 Chapter A of Annex III 
and point 8 of Part I.A of Chapter B  of Annex III should therefore be amended to 
provide for an appropriate monitoring and reporting of the genotype of positive TSE 
cases in goats.  
(4) In addition, Regulation (EC) No 999/2001 lays down rules concerning spe cified risk 
material, and provides, inter alia, that specified risk material is to be removed and 
disposed of in accordance with Annex V thereto and with Regulation (EC) No 
1069/2009 of the European Parliament and of the Council4. More particularly, point 
1(b) of Annex V to Regulation (EC) 999/2001 defines  specified risk material, in ovine 
and caprine 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 spec ificity of the farming of ovine and caprine animals, the determination 
of the exact date of birth of ovine and caprine animals is rarely feasible and thus such 
data is not included in the holding register required in accordance with Council 
Regulation (EC)  No 21/20045. Therefore, prior to the amendment of Annex V to 
Regulation (EC) No 999/2001 by Commission Regulation (EU) 2018/9696, the 
removal of specified risk material was required in  ovine and caprine  animals aged over 
12 months or in ovine and caprine 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 approved by the competent authority of the 
Member State of slaughter to identify ovine and caprine 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 intended to be only applied in the Member 
States and not to be extended to third countries. Accordingly, in the interests of legal 
certainty and clarity, it is now appropriate to delete it. Therefore, the possibility to use 
a method approved by the com petent authority of the Member State of slaughter to 
identify ovine and caprine 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 con trol and 
eradication of TSEs, including atypical scrapie.  In particular, Chapter B of that Annex 
lays down the measures to be applied following confirmation of the presence of a TSE 
in bovine, ovine and caprine animals.  Commission Regulation (EU) No 630/20 137 
                                                 
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 produ cts not intended for human 
consumption and repealing Regulation (EC) No  1774/2002 (Animal by -products Regulation) (OJ L 
300, 14.11.2009, p. 1).  
5  Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification 
and regis tration of ovine and caprine 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 regards the requirements for the removal of 
specified risk materials 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 (E C) 
No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, EN 3  EN amended Annex VII to Regulation (EC) No 999/2001 in order to lift all restriction 
measures on the movement of ovine and caprine animals where a case of atypical 
scrapie has been confirmed, 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 adoption of Regulation (EU) No 630/2013 a significant amount of data has 
been collected. The measure laid down in point 2.2.3 of Chapter B of Annex VII to 
Regul ation (EC) No 999/2001, which is not related to public health concerns, should 
therefore now be deleted  
(8) Chapter C of Annex IX to Regulation (EC) No 999/2001 lays down the requirements 
for the importation into the Union of products of bovine, ovine and cap rine animals. 
These requirements  vary according to the BSE status of the country or region of origin 
of the products, as well as according to the BSE status of the country or region of 
origin of the animals from which the products were derived. The BSE sta tus of 
countries or regions according to their BSE risk is set out in Commission Decision 
2007/4538, which lists the countries or regions with a negligible BSE risk and with a 
controlled BSE risk, and provides that all other countries or regions are to be regarded 
as having an undetermined BSE risk.  
(9) Specific requirements are laid down in points (g) and (h) of Section B of Chapter C  of 
Annex IX to Regulation (EC) No 999/2001 , to address the case of the importation of 
products from a country or region with a negligible BSE risk derived from animals 
originating from a country or region with an undetermined 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.  
(10) The specific requirements  laid down in points (g) and (h) of Section B of C hapter 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 Chapter , for the direct importation 
into the Union from a country or region with an undetermined BSE risk.   However, 
those specific requirements are not currently laid down in  Section C of Chapter C of 
Annex IX to Regulation (EC) No 999/2001, which lays down the requirements for 
imports from a country 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 country or region with a controlled BSE risk, products derived from animals 
originating from a country or region with an undetermined BSE risk which do not 
compl y with those specific requirements. The specific requirements laid down in 
points (g) and (h) of Section B of Chapter C of Annex IX to Regulation (EC) No 
999/2001 should therefore be inserted in Section C of Chapter C of that Annex.  
(11) Annexes III, V, VII and  IX to Regulation (EC) No 999/2001 should therefore be 
amended accordingly.  
(12) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing  Committee on Plants, Animals, Food and Feed,    
                                                                                                                                                         
control and eradication of certain transmissible spongiform encephalopathies (OJ L 179, 29 .6.20 13, p. 
60) 
8  Commission Decision (EU) No 2007/453 of 29 June 2007 establishing the BSE status of Member States 
or third countries or regions thereof according to their BSE risk  (OJ L 172, 30.6.2007, p. 84 ) EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1 
Annexes 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 on the twentieth  day following 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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN