REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal Health Law’)
Date: 2025-06-19
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, animal disease, delegated legislation, disease prevention, health risk, powers of the institutions (EU), protection of animal life, transfer of competence, veterinary inspection

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 19.6.2025  COM(2025) 316 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal Health Law’)  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 

on the exercise of the power to adopt delegated acts conferred on the Commission 
pursuant to Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal 
Health Law’) 

1.  INTRODUCTION 

Regulation (EU) 2016/429 on transmissible animal diseases ('Animal Health Law')(1) was 
adopted  in  2016.  This  Regulation  entered  into  force  on  21  April  2016,  and  it  has  been 
applicable since 21 April 2021.  

The Regulation replaces the entire body of fully harmonised animal health legislation (39 
Directives  and  Regulations)  and  provides  for  a  simpler  and  more  flexible  regulatory 
framework  while  ensuring  a  more  risk-based  approach  to  set  out  animal  health 
requirements,  enhanced  disease  preparedness,  prevention  and  control  for  listed 
transmissible diseases. 

In  addition,  it  clarifies  the  role  of  the  different  actors  in  animal  health  and  opens 
possibilities to reduce administrative burden for farmers, other operators and competent 
authorities without compromising the animal health status in the Union. Furthermore, it 
provides more suitable tools to deal with crisis situations (e.g. emerging  diseases) or to 
address  specific  risks  (e.g.  antimicrobial  resistance)  and  contributes  to  fewer  economic 
losses due to disease outbreaks. 

According to  its provisions, the Commission  is  empowered to  adopt  a large number of 
implementing  and  delegated  acts.  It  also  imposes  on  the  Commission  the  obligation  to 
report to the co-legislator on the exercise of the delegated powers it contains.  

2.  LEGAL BASIS 

This report is required under Article 264(3) of Regulation (EU) 2016/429. Pursuant to this 
provision,  the  power  to  adopt  delegated  acts  concerning  the  matters  listed  therein  is 
conferred  on  the  Commission  for  a  period  of  five  years  from  20  April  2016  and  the 
Commission is required to prepare a report in respect of the delegated power at the latest 
nine months before the end of the five-year period. The previous report was published on 
12 February 2021(2). 

According  to  Article  264(3),  the  Commission  is  empowered    to  adopt  delegated  acts 
referred to in Articles 3(5), 5(2) 5(4), 14(3), 16(2), 18(3), 20(3), 29, 31(5), 32(2), 37(5), 
39, 41(3), 42(6), 47(1), 48(3), 53(2), 54(3), 55(2), 58(2), 63, 64(4), 67, 68(2), 68(3), 70(3), 
72(2),  73(3),  74(4),  76(5),  77(2),  87(3),  94(3),  97(2),  101(3),  106(1),  109(2),  118(1), 
118(2), 119(1), 122(1), 122(2), 125(2), 131(1), 132(2), 135, 136(2), 137(2), 138(3), 139(4), 
140, 144(1), 146(1), 147, 149(4), 151(3), 154(1), 156(1), 160(1), 160(2), 161(6), 162(3), 
162(4),  163(5),  164(2),  165(3),  166(3),  167(5),  168(3),  169(5),  176(4),  181(2),  185(5), 
189(1), 192(2), 197(3), 200(3), 201(3), 202(3), 203(2), 204(3), 205(2), 211(1), 213(1), 214, 

(1)   OJ L 084 31.3.2016, p. 1 

(2)  COM/2021/57 final 

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216(4),  218(3),  221(1),  222(3),  223(6),  224(3),  228(1),  230(3),  234(2),  237(4),  239(2), 
240(2), 241(2), 242(2), 245(3), 246(3), 249(3), 252(1), 254, 263, 271(2), 272(2), 279(2), 
and 280(4) of Regulation (EU) 2016/429. 

Article 264(3) of that Regulation lays down that the delegation of power shall be tacitly 
extended  for  periods  of  an  identical  duration,  unless  the  European  Parliament  or  the 
Council opposes such extension not later than three months before the end of each period, 
while Article 264(4) states that the delegation of power may be revoked at any time by the 
European Parliament or by the Council. 

3.  EXERCISE OF THE DELEGATION 

The Commission exercised the delegation based on Regulation (EU) 2016/429 as from 
2018 onwards and drew up a report on the exercised powers for the period from 2016 to 
2021 in 2021 (3).  

This is the second report on the exercised powers under the cited regulation and it covers 
a five-year period as from the last report, from 2021 onwards.  

During the reporting period, the Commission exercised its delegated powers, by adopting 
the following delegated acts: 

•  Commission  Delegated  Regulation  (EU)  2022/139  of  16  November  2021 
supplementing Regulation (EU) 2016/429 of the European Parliament and of the 
Council as regards the management, storage and replacement of stocks of the Union 
antigen, vaccine and diagnostic reagent banks and the biosecurity, biosafety and 
bio-containment requirements for the operation of those banks (4); 

•  Commission  Delegated  Regulation  (EU)  2023/361  of  28  November  2022 
supplementing  Regulation  (EU)  2016/429  of  the  European  Parliament  and  the 
Council as regards rules for the use of certain veterinary medicinal products for the 
purpose of prevention and control of certain listed diseases (5); 

•  Commission Delegated Regulation (EU) 2024/2623 of 30 July 2024 supplementing 
Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council  as 
regards rules for approval and recognition of disease-free status of compartments 
keeping terrestrial animals (6). 

By now the Commission has used 85 of the 110 empowerments to adopt delegated acts 
as provided in Regulation (EU) 2016/429. 

The below table shows the additional acts adopted since the previous report was published 
and the relevant empowerments in Regulation (EU) 2016/429. 

(3)  COM/2021/57 final 

(4)  OJ L 23, 2.2.2022, p. 1–10 

(5)  OJ L 52, 20.2.2023, p. 1–42 

(6)  OJ L, 2024/2623, 4.10.2024 

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Empowerments  in  Regulation  (EU) 
2016/429 

Article 48(3) 

Article 47(1) 

Delegated Act 

of 

16  November 

(EU) 
Commission  Delegated  Regulation 
2022/139 
2021 
supplementing  Regulation (EU) 2016/429  of 
the European Parliament and of the Council as 
regards 
storage  and 
replacement  of  stocks  of  the  Union  antigen, 
vaccine and diagnostic reagent banks and the 
biosecurity,  biosafety  and  bio-containment 
requirements for the operation of those banks 

the  management, 

of 

28  November 

(EU) 
Commission  Delegated  Regulation 
2023/361 
2022 
supplementing  Regulation (EU) 2016/429  of 
the  European  Parliament  and  the  Council  as 
regards rules for the use of certain veterinary 
medicinal  products  for 
the  purpose  of 
prevention  and  control  of  certain  listed 
diseases 

Article 37(5) 

Commission  Delegated  Regulation 
(EU) 
2024/2623  of  30  July  2024  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament and of the Council as regards rules 
for  approval  and  recognition  of  disease-free 
status  of  compartments  keeping  terrestrial 
animals 

Moreover,  several  Delegated  Regulations  adopted  before  2021  and  included  in  the 
previous report, were amended as follows:  

Delegated Regulation: 

Amended by: 

Empowerments 
Regulation 
2016/429 

in 
(EU) 

Delegated 
Commission 
Regulation 
(EU) 
2019/2035 of  28  June  2019 
supplementing  Regulation 
(EU) 
the 
European  Parliament  and  of 
the  Council  as  regards  rules 
for  establishments  keeping 
and 
terrestrial 

2016/429 

animals 

of 

Commission 
Delegated 
Regulation (EU) 2020/1625 of 
25 August 2020 (8) 

Articles 
118(2) 

118(1), 

Commission 
Delegated 
Regulation (EU) 2021/2168 of 
21 September 2021 (9) 

Articles 
94(3),97(2),118(1), 
118(2), 122(2) 

(8)  OJ L 366, 4.11.2020, p. 1 

(9)  OJ L 438, 8.12.2021, p. 38 

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and 

hatcheries, 
the 
traceability  of  certain  kept 
terrestrial 
and 
hatching eggs (7) 

animals 

of 

2016/429 

December 

Commission 
Delegated 
Regulation (EU) 2020/686 of 
17 
2019 
supplementing  Regulation 
(EU) 
the 
European  Parliament  and  of 
the  Council  as  regards  the 
approval of germinal product 
establishments 
the 
traceability and animal health 
requirements  for  movements 
within the Union of germinal 
products  of  certain  kept 
terrestrial animals (11) 

and 

December 

Commission 
Delegated 
Regulation (EU) 2020/687 of 
2019 
17 
supplementing  Regulation 
(EU) 
the 
European Parliament and the 
Council,  as  regards  rules  for 
the prevention and control of 
certain listed diseases (14) 

2016/429 

of 

Commission 
Delegated 
Regulation  (EU)  2023/590 of 
12 January 2023 (10) 

Commission 
Delegated 
Regulation (EU) 2021/880 of 5 
March 2021 (12) 

Articles  3(5),  87(3), 
94(3),  97(2),  101(3), 
118(1), 
106(1), 
118(2), 
119(1), 
122(2), 271(2), 279(2) 

Articles 
122(1), 
122(2), 160(1), 160(2) 
162(4), 
162(3), 
164(2), 
163(5), 
165(3), 279(2) 

Commission 
Delegated 
Regulation  (EU)  2023/647 of 
13 January 2023 (13) 

Articles 160(1), 
160(2), 
and 164(2) 

162(4) 

Commission 
Delegated 
Regulation (EU) 2021/1140 of 
5 May 2021 (15) 

The first  paragraph of 
Articles 67,  
Article 272(2) 

Commission 
Delegated 
Regulation  (EU)  2023/751  of 
30 January 2023 (16) 

Article 67 

Delegated 
Commission 
Regulation (EU) 2020/688 of 
17 
2019 
supplementing  Regulation 

December 

Delegated 
Commission 
Regulation (EU) 2021/1706 of 
14 July 2021 (18) 

Articles 
131(1), 135, 136(2), 
140, 
144(1), 
156(1) 

147, 

(7)  OJ L 314, 5.12.2019, p. 115 

(10)  OJ L 79, 17.3.2023, p. 46 

(11)  OJ L 174, 3.6.2020, p. 1 

(12)  OJ L 194, 2.6.2021, p. 1 

(13)  OJ L 81, 21.3.2023, p. 1 

(14)  OJ L 174, 3.6.2020, p. 64 

(15)  OJ L 247, 13.7.2021, p. 50 

(16)  OJ L 100, 13.4.2023, p. 7 

(18)  OJ L 339, 24.9.2021, p. 56 

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of 

2016/429 

(EU) 
the 
European  Parliament  and  of 
the  Council,  as 
regards 
animal  health  requirements 
for  movements  within  the 
Union  of  terrestrial  animals 
and hatching eggs (17) 

2016/429 

December 

Commission 
Delegated 
Regulation (EU) 2020/689 of 
17 
2019 
supplementing  Regulation 
(EU) 
the 
European  Parliament  and  of 
the  Council  as  regards  rules 
for  surveillance,  eradication 
programmes,  and  disease-
free  status  for  certain  listed 
and emerging diseases (22) 

of 

Commission 
Delegated 
Regulation  (EU)  2023/118  of 
23 September 2022 (19) 

Articles 
149(4) 

140(b), 

Commission 
Delegated 
Regulation (EU) 2023/2515 of 
8 September 2023 (20) 

Commission 
Delegated 
Regulation (EU) 2024/3160 of 
9 October 2024 (21) 

Commission 
Delegated 
Regulation  (EU)  2021/881 of 
23 March 2021 (23) 

Articles 131(1), points 
(c)  and  (d),  132(2), 
140(b),  144(1),  points 
(a) 
(b), 
and 
Article 146(1), 
Article 149(4)  

Article 131(1),  points 
(c) and (d), 

the 
introductory 
phrase  and  points  (a) 
and  (d)  of  Article  29, 
the 
introductory 
phrase  and  points  (a) 
of 
(b) 
and 
the 
Article 31(5), 
phrase 
introductory 
(c)  of 
and  point 
the 
Article 32(2), 
introductory 
phrase 
and  points  (a)  and  (b) 
Article 41(3), 
of 
Article 42(6) 

Commission 
Delegated 
Regulation (EU) 2023/1570 of 
23 May 2023 (24) 

Article 42(6) 

Delegated 
Commission 
Regulation (EU) 2023/1798 of 
10 July 2023 (25) 

Articles 29,  points  (a) 
and 
(d),  37(5), 39, 
41(3) 

(17)  OJ L 174, 3.6.2020, p. 140 

(19)  OJ L 16, 18.1.2023, p. 1 

(20)  OJ L 2023/2515, 14.11.2023 

(21)  OJ L 2024/3160, 20.12.2024 

(22)  OJ L 174, 3.6.2020, p. 211 

(23)  OJ L 194, 2.6.2021, p. 10 

(24)  OJ L 192, 31.7.2023, p. 9 

(25)  OJ L 233, 21.9.2023, p. 24 

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of 

January 

2016/429 

Commission 
Delegated 
Regulation (EU) 2020/692 of 
30 
2020 
supplementing  Regulation 
(EU) 
the 
European  Parliament  and  of 
the  Council  as  regards  rules 
for entry into the Union, and 
the  movement  and  handling 
after entry of consignments of 
certain  animals,  germinal 
products  and  products  of 
animal origin (26) 

Commission 
Delegated 
Regulation (EU) 2021/1703 of 
13 July 2021 (27)  

Articles 
237(4), 239(2) 

234(2), 

Commission 
Delegated 
Regulation (EU) 2021/1705 of 
14 July 2021 (28) 

Articles 
234(2), 
237(4), 239(2), 279(2) 

Delegated 
Commission 
Regulation  (EU)  2022/54 of 
21 October 2021 (29) 

Article 239(2) 

Commission 
Delegated 
Regulation  (EU)  2023/119 of 
9 November 2022 (30) 

Articles  3(5),  234(2), 
237(4), 239(2) 

Certain empowerments of Regulation (EU) 2016/429 have not been used to date, for the 
reasons explained below. 

•  The empowerments of Article 14(3) on tasks that competent authorities can delegate 
to veterinarians other than official veterinarians and of Article 16(2) on safety measures 
in laboratories were not used so far. The Commission is continuing to assess the need 
to prepare specific acts relating to both these empowerments. 

•  The  empowerments  of  Articles  18(3)  and  20(3)  related  to  disease  notification  and 
reporting  were  not  used  so  far.  The  Commission  will  assess  the  need  to  act  in  this 
respect in the light of experience on the practical application of the new rules. The same 
is true for empowerments Article 151(3) on self-declaration documents for terrestrial 
animals and Article 167(5) with regard to derogations from the certification obligation 
for the movements of products of animal origin.  

•  The  empowerment  of  Article  109(2)  concerning  the  recording  of  information  in 
computer database of kept terrestrial animals of animal species other than those set out 
in the basic regulation was not used so far. Nevertheless, it has to be extended to enable 
the Commission to lay down requirements for the computer database for those animal 
species if, or when, such need arises in the future. In accordance with this provision, 
the Commission continuously assesses the need to proceed with the preparation of a 
delegated act to lay down such requirements. 

•  The empowerments of Article 138(3) and 139(4) as regards the rules for the granting 
of derogations by competent authorities for certain movements of terrestrial animals 
were not used so far. Similar conditions apply for the empowerments of Articles 200 
and Article 204 on certain types of movements of aquatic animals and Article 214 as 

(26)  OJ L 174, 3.6.2020, p. 379 

(27)  OJ L 339, 24.9.2021, p. 29 

(28)  OJ L 339, 24.9.2021, p. 40 

(29)  OJ L 10, 17.1.2022, p. 1 

(30)  OJ L 16, 18.1.2023, p. 5 

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regards rules for animal health certification for specific types of movements of aquatic 
animals. The Commission will continuously assess the need to act in this respect in the 
light of experience on the practical application of the new rules. 

•  The empowerment of Article 228 enabling the Commission to lay down animal health 
requirements  for “other  animals”, i.e. animals  that are neither terrestrial  nor aquatic 
animals, was not used so far. The Commission has not acted to date, but it should be 
in  a  position  to  lay  down  animal  health  rules  for  such  animals  (e.g.  reptiles, 
amphibians)  when  the  health  risk  involved  requires  more  detailed  or  specific 
traceability, disease prevention or control rules for such species. 

•  The  empowerment  of  Article  230(3)  as  regards  limiting  the  possibility  for  Member 
States  to  draw  lists  of  third  countries  from  which  they  can  allow  entry  of  certain 
commodities in the Union in the absence of the lists to be drawn up in Union legislation 
was not used so far. The lists of third countries for all commodities are not drawn up 
in Union legislation. The Commission follows closely the evolvement of the lists and 
assesses  the  need  for  the  rules  to  be  adopted  based  on  this  empowerment.  The 
Commission therefore considers it prudent to keep this empowerment for the future. 

•  The empowerments of Articles 240 to 242 give powers to the Commission to lay down 
at  Union  level  specific  protective  and  preventive  measures,  including  biosecurity, 
related  to  entry  into  the  Union  of  certain  products  and  means  of  transport.  These 
empowerments  are  important  as  they  provide  for  a  possibility  for  such  rules  to  be 
developed in the future in order to prevent the spread of animal diseases into the EU 
and contribute to reinforce biosecurity at the EU external borders. 

•  A  delegated  act  on  non-commercial  movements  of  pet  animals  using  the 
empowerments  of  Part  VI  (Articles  245  to  254)  of  Regulation  (EU)  2016/429  is  in 
development and its adoption is planned in 2025. 

•  The empowerment of Article 263 to amend Annex III to Regulation (EU) 2016/429 
was not used during the reporting period, as there were no taxonomical changes giving 
the reason for such amendment. Such taxonomical changes may happen at any time 
and  the  Commission  may  need  to  react  accordingly  and  introduce  necessary 
amendments. 

4.  CONCLUSION 

Given the fact that Regulation (EU) 2016/429 has been in force since 21 April 2021 and 
that the empowerments have been used so far extensively and for the benefit of Member 
States and the agriculture and aquaculture sectors in the Union, the Commission sees the 
need to extend all empowerments to adopt delegated acts as provided for in that Regulation 
beyond  the  current  five-year  period.  The  possibility  to  develop  rules  based  on  the 
empowerments remains of importance in order to provide the necessary flexibility in the 
implementation of the rules, their simplification and clarification, to adjust them regularly 
to  the latest  scientific standards and to  give possibility  to the Commission to  act  in  the 
areas where it did not to this moment, but it may need to do so in the future. 

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