EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11090/2021 CIS 
(POOL/G4/2021/11090/11090 -EN 
CIS.docx)  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes VIII and IX to Regulation (EC) No 999/2001 of the European 
Parliament and of the Council as regards Chronic Wasting Disease  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes VIII and IX to Regulation (EC) No 999/2001 of the European 
Parliament and of the Council as regards chronic wasting disease  in live cervids  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning o f 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 spongiform encephalopathies1, and in part icular Article 23a , points (j) 
and (m) , thereof,  
Whereas:  
(1) Regulation (EC) No 999/2001 lays down rules for the prevention, control and 
eradication of transmissible spongiform encephalopathies in the Union. It applies to 
the production and placing on the mar ket of live animals and products of animal origin 
and in certain specific cases to exports thereof. Annex VIII to Regulation (EC) No 
999/2001 sets out the rules for intra -Union trade and Annex IX to that Regulation sets 
out the rules relating to imports into the Union.  It also provides, inter alia, for the 
adoption of safeguard measures in the event of outbreaks of TSEs.  
(2) Chronic wasting disease  is a transmissible spongiform encephalopathy  of cervids 
which is infectious and thus can cause disturbance to tr ade within the Union, imports 
into the Union and exports to third countries.  
(3) Norway informed the Commission, on 1 April 2016, of the first case  of chronic 
wasting disease  confirmed in its territory , in a wild reindeer . That was the first time 
that chronic wasting disease  had been detected in Europe and the first natural case in a 
reindeer in the world.  From this first case until October  2021, Norway confirmed at 
least one case each year, with a total of thirty  one cases: twenty in wild reindeer, two 
in red deer and nine in moose.  
(4) Norway adopted on 11 July 2016 a measure to prohibit the export from Norway of live 
cervids, without prejudice to specific derogations.  
(5) Since chronic wasting disease  is an infectious disease , there is a risk that it can spre ad 
to other cervid populations and to other regions in the Union and in the European Free 
Trade Association States.  Commission Implementing Decision (EU) 2016/19182 was 
therefore adopted. It prohibited the movement of live cervids from Norway into the 
Union  and provided for  specific derogations.  
                                                 
1 OJ L 147, 31.5.2001, p. 1.  
2 Commission Implementing Decision (EU) 2016/1918 of 28 October 2010 concerning certain safeguard 
measures in relation to chronic wasting disease  (OJ L 296, 1.11.2016, p. 21 ). EN 2  EN (6) On 2 December 2016, the European Food Safety Authority (EFSA) adopted a 
scientific opinion on chronic wasting disease in cervids (the 2016 EFSA Opinion)3. 
This opinion recommended the implementation of a 3 -year surveillance programme 
for chronic wasting disease  in cervids in Estonia, Finland, Iceland, Latvia, Lithuania, 
Norway, Poland and Sweden, which are the Member States and the EFTA States with 
a reindeer or a moose population, or with both populations, in or der to detect and to 
estimate the prevalence and geographical spread of chronic wasting disease . The 2016 
EFSA Opinion also concluded that the most likely pathway of introduction and spread 
of chronic wasting disease  was the movement of live cervids and hi ghlighted that  the 
use of natural cervid urine  hunting  lures increase d the probability of introduction of 
chronic wasting disease . It therefore recommended minimising the movements of live 
cervids and discontinuing the use of cervid urine hunting lures.  
(7) Following the adoption of the 2016 EFSA Opinion, Annex III to Regulation (EC) No 
999/2001 was amended by Commis sion Regulation (EU) 2017/19724 in order to 
provide for a 3 -year monitoring programme for chronic wasting disease  in cervids , 
while  Commission Im plementing Decision (EU) 2017/21815 extended the validity of 
Implementing Decision (EU) 2016/1918 until the end of 2020  to allow for the 
safeguard measures to remain applicable until the end of that 3-year monitoring 
programme . Implementing Decision (EU) 2 017/2181 also added prohibitions and 
restrictions regarding cervid urine hunting lures  to the safeguard measures . 
(8) In 2018, Finland detected the first case of chronic wasting disease  in the Union and an 
additional case in November 2020. Sweden detected three cases  of chronic wasting 
disease  in 2019 and an additional case in September 2020. All cases of chronic 
wasting disease detected in Finland and Sweden were  confirmed in the context of the 
3-year monitoring programme for chronic wasting disease  in cer vids and were found 
in wild moose.  
(9) On 11 November 2019, the EFSA  published the Scientific Opinion “Update on 
chronic wasting disease (CWD) III ”6 (the 2019 EFSA Opini on) with various 
recommendations to the Commission , including in relation to the risk facto rs that can 
facilitate the spread of chronic wasting disease in the Union . 
(10) Taking into account the detection of new cases of chronic wasting disease in Norway, 
Finland and Sweden, pending the scientific assessment of the results of the monitoring 
programme, and considering that additional time was needed to reflect on the 
recommendations of the 2019 EFSA Opinion, the period of application of  
Implement ing Decision (EU) 2016/1918 was again extended by Commission 
Implementing Decision (EU) 2020/21677, until 31 December 2022 , to reflect the more 
recent confirmation s of chronic wasting disease  in Finland and Sweden . 
                                                 
3 EFSA Journal 2017 ;15(1): 4667.  
4 Commission Regulation (EU) 2017/1972 of 30 October 2017 amending Annexes I and III to Regulation 
(EC) No 999/2001 of the European Parliament and of the Council as regards a surveillance programme 
for chronic wasting disease in cervids in Estonia, Finland, Latvia, Lithuania, Pol and and Sweden and 
repealing Commission Decision 2007/182/EC  (OJ L 281, 31.10.2017, p. 14 ). 
5 Commission Implementing Decision (EU) 2017/2181 of 21 November 2017 amending Implementing 
Decision (EU) 2016/1918 concerning certain safeguard measures in relatio n to chronic wasting disease  
(OJ L 307, 23.11.2017, p. 58 ). 
6 EFSA Journal 2019;17(11)5863 .  
7 Commission Implementing Decision (EU) 2020/2167 of 17 December 2020 amending Implementing 
Decision (EU) 2016/1918 concerning certain safeguard measures in relati on to chronic wasting disease 
by extending its period of application  (OJ L 431, 21.12.2020, p. 70 ). EN 3  EN (11) Considering that the safeguard measures o f Implementing Decision (EU) 2016/1918 
have been appl ied since 2016, that the latest epidemiological situation regarding 
chronic wasting disease  does not allow to envisage its eradication anytime soon , that it 
would be legally inappropriate to extend again the application of the safeguard 
measures based on article 4 of Regulation (EC) No 999/2001 , and that measures 
should nevertheless  remain applicable to keep on preventing chronic wasting disease 
from spread ing further in the U nion and the EFTA States, Annexes VIII and IX to 
Regulation (EC) No 999/2001 should be amended to include the measures currently 
laid down in Implementing Decision (EU) 2016/1918 , adjusted as necessary to take 
into account the confirmat ion of chronic wasting disease  in Finland and Sweden .  
(12) Consequently, based on conclusions from the 2016 and 2019 EFSA opinions, it is 
necessary to maintain  the prohibition of the movement of live cervids from Norway 
into the Union. For practical reasons, that prohibition should continue to apply to live 
cervids moved in conjunction with human activity, but not to movements of wild 
cervids crossing the border  of Norway without any human intervention. Specific 
derogations from  that prohibition should be laid down to allow certain movements of 
live cervids from Norway into the Union , including the cross -border seasonal grazing 
of semi -domesticated reindeer , and the movements of semi -domesticated reindeer to 
be used in cultural or sportive events in Sweden. However, due to the animal health 
risk that the movements allowed by th ose derogations represent s, notably in terms of 
environmental contamination with chronic  wasting disease  prions in the areas of 
destination, such movements should remain  restricted to defined areas in Finland and 
Sweden, and movements of live cervids from those areas should remain  prohibited, 
without prejudice to specific derogations . 
(13) Conside ring that chronic wasting disease has now been confirmed in two Member 
States , and based on conclusions from the 2016 and 2019 EFSA opinions on the risk 
factors that can facilitate the spread of chronic wasting disease  in the Union , it is 
necessary to provide for a prohibition of the movement of live cervids from a Member 
State concerned by that disease to the rest of the Union. For practical reasons, that 
prohibition should apply to live cervids moved in conjunction with human activity, but 
not to movements of wild cervids without any human intervention.  Specific 
derogations to that prohibition should be laid down to allow certain movements of live 
cervids from the Member States  concerned by the chronic wasting disease , including 
with the purpose to  ensure safe access to, and valorisation of, valuable cervid genetic 
resources  between Member States  concerned . 
(14) The prohibition of import of urine hunting lures derived from cervids  and the 
prohibition of movement of urine hunting lures  derived from cervid s originating in 
Norway  should be maintained . In addition, the movements of cervid urine hunting 
lures derived from cervids originating in Member States where cases of chronic 
wasting disease have been confirmed should be prohibited .  
(15) Annexes VIII and IX t o Regulation (EC) No 999/2001 should therefore be amended 
accordingly.  
(16) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  EN 4  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Annex es VIII 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 following that of its publication in 
the Official Journal of the European Union . 
 
It shall apply from 1 January 2023.  
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