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: 2021-02-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal disease, delegated legislation, disease prevention, health risk, powers of the institutions (EU), protection of animal life, transfer of competence, veterinary medicine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 12.2.2021  COM(2021) 57 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 shall apply from 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. 

According the 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,  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. 

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 OJ L 084 31.3.2016, p. 1 

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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 

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

  Commission Delegated Regulation (EU) 2018/1629 of 25 July 2018 amending the list of 
diseases set out in Annex II to Regulation (EU) 2016/429 of the European Parliament and 
of the Council on transmissible animal diseases and amending and repealing certain acts 
in the area of animal health (‘Animal Health Law’)2 

  Commission  Delegated  Regulation  (EU)  2019/2035  of  28  June  2019  supplementing 
Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules 
for  establishments  keeping  terrestrial  animals  and  hatcheries,  and  the  traceability  of 
certain kept terrestrial animals and hatching eggs3 

  Commission  Delegated  Regulation  (EU)  2020/686  of  17  December  2019  supplementing 
Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the 
approval  of  germinal  product  establishments  and  the  traceability  and  animal  health 
requirements  for  movements  within  the  Union  of  germinal  products  of  certain  kept 
terrestrial animals4 

  Commission  Delegated  Regulation  (EU)  2020/688  of  17  December  2019  supplementing 
Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council,  as  regards 
animal  health  requirements  for  movements  within  the  Union  of  terrestrial  animals  and 
hatching eggs5 

  Commission  Delegated  Regulation  (EU)  2020/689  of  17  December  2019  supplementing 
Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules 
for  surveillance,  eradication  programmes,  and  disease-free  status  for  certain  listed  and 
emerging diseases6 

  Commission  Delegated  Regulation  (EU)  2020/687  of  17  December  2019  supplementing 
Regulation (EU) 2016/429 of the European Parliament and the Council, as regards rules 
for the prevention and control of certain listed diseases7 

  Commission  Delegated  Regulation  (EU)  2020/691  of  30  January  2020  supplementing 
Regulation (EU) 2016/429 of the European Parliament and of Council as regards rules for 
aquaculture establishments and transporters of aquatic animals8,  

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3  
4  
5  
6  
7  
8  

OJ L 272, 31.10.2018, p. 11 
OJ L 314, 5.12.2019, p. 115 
OJ L 174, 3.6.2020, p. 1 
OJ L 174, 3.6.2020, p. 140 
OJ L 174, 3.6.2020, p. 211 
OJ L 174, 3.6.2020, p. 64 
OJ L 174, 3.6.2020, p. 345 

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  Commission  Delegated  Regulation  (EU)  2020/692  of  30  January  2020  supplementing 
Regulation (EU) 2016/429 of 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 origin9 

  Commission  Delegated  Regulation  (EU)  2020/990  of  28  April  2020  supplementing 
Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council,  as  regards 
animal  health and  certification requirements for  movements  within the Union  of aquatic 
animals and products of animal origin from aquatic animals10 

  Commission  Delegated  Regulation  (EU)  2020/2154  of  14  October  2020  supplementing 
Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council  as  regards 
animal health, certification and notification requirements for movements within the Union 
of products of animal origin from terrestrial animals11. 

By  now  the  Commission  has  used  83  of  the  110  empowerments  to  adopt  delegated  acts  as 
provided  in  Regulation  (EU)  2016/429.  Some  of  these  delegated  powers  were  bundled  in  a 
single  delegated  act  where  the  rules  are  substantively  linked.  The  bundling  in  a  single  act 
rather than a number of cross-referenced separate acts was considered necessary in the interest 
of  simplicity,  transparency,  to  facilitate  the  effective  application  of  the  rules  and  to  avoid 
duplication. 

The below table shows which acts contain the specific measures adopted under the relevant 
empowerments in Regulation (EU) 2016/429. 

Delegated Act 

Commission  Delegated  Regulation 
(EU) 
2018/1629 of 25 July 2018 amending the list of 
diseases set out in Annex II to Regulation (EU) 
2016/429 of the European Parliament and of the 
Council  on  transmissible  animal  diseases  and 
amending  and  repealing  certain  acts  in  the  area 
of animal health (‘Animal Health Law’) 
Commission  Delegated  Regulation 
(EU) 
2019/2035  of  28  June  2019  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament  and  of  the  Council  as  regards  rules 
for  establishments  keeping  terrestrial  animals 
and  hatcheries,  and  the  traceability  of  certain 
kept terrestrial animals and hatching eggs 
(EU) 
Commission  Delegated  Regulation 
2020/686  of  17  December  2019  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament  and  of  the  Council  as  regards  the 
approval of germinal product establishments and 
the  traceability  and  animal  health  requirements 

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10  
11  

OJ L 174, 3.6.2020, p. 379 
OJ L 221, 10.7.2020, p. 42 
OJ L 431, 21.12.2020, p. 5 

Empowerments in Regulation (EU) 
2016/429 
Article 5(2) and (4) 

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

Articles 94(3), Article 97(2), Article 
101(3), Article 106(1), Article 122(1) and 
(2), Article 131(1), Article 160(1) and 
(2), Article 161(6), Article 162(3) and 
(4), Article 163(5), Article 164(2), 
Article 165(3) and Article 279(2) 

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for  movements  within  the  Union  of  germinal 
products of certain kept terrestrial animals 
Commission  Delegated  Regulation 
(EU) 
2020/688  of  17  December  2019  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament and of the Council, as regards animal 
health  requirements  for  movements  within  the 
Union of terrestrial animals and hatching eggs 

Commission  Delegated  Regulation 
(EU) 
2020/687  of  17  December  2019  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament and the Council, as regards rules for 
the  prevention  and  control  of  certain  listed 
diseases 

(EU) 
Commission  Delegated  Regulation 
2020/689  of  17  December  2019  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament  and  of  the  Council  as  regards  rules 
for  surveillance,  eradication  programmes,  and 
disease-free  status 
listed  and 
emerging diseases 
(EU) 
Commission  Delegated  Regulation 
2020/691  of  30  January  2020  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament  and  of  Council  as  regards  rules  for 
aquaculture  establishments  and  transporters  of 
aquatic animals  

for  certain 

Commission  Delegated  Regulation 
(EU) 
2020/692  of  30  January  2020  supplementing 
Regulation  (EU)  2016/429  of  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 
(EU) 
Commission  Delegated  Regulation 
2020/990  of  28  April  2020  supplementing 
Regulation  (EU)  2016/429  of  the  European 
Parliament and of the Council, as regards animal 
for 
health  and 
movements within the Union of aquatic animals 
and  products  of  animal  origin  from  aquatic 
animals 
Commission  Delegated  Regulation 
(EU) 
2020/2154  of  14  October  2020  supplementing 

requirements 

certification 

Article 3(5), Article 125(2), Article 
131(1), Article 132(2), Article 135, 
Article 136(2), Article 137(2), Article 
140, Article 144(1), Article 146(1), 
Article 147, Article 149(4), Article 
154(1), Article 156(1), Article 160, 
Article 162(3) and (4), Article 163(5)(b) 
and (c) and Article 164(2) 
Articles47(1), Article 53(2), Article 
54(3), Article 55(2), Article 58(2), the 
first paragraph of Article 63, Article 
64(4), the first paragraph of Article 67, 
Article 68(3), Article 70(3), Article 
72(2), Article 73(3), Article 74(4), 
Article 76(5), Article 77(2) and Article 
272(2) 
Article 29, Article 31(5), 32(2), 37(5), 
Article 39, Article 41(3), Article 42(6) 
and Article 280(4) 

Articles 176(4), 181(2), 185(5), 189(1) 
and 279(2) 

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

Articles 192(2), 197(3), 201(3), 202(3), 
205(2), 211(1), 213(1), 216(4), 218(3), 
221(1), 222(3), 223(6), and 224(3) 

Articles 166(3), 168(3) and 169(5) 

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Regulation  (EU)  2016/429  of  the  European 
Parliament and of the Council as regards animal 
health, 
notification 
requirements for movements within the Union of 
terrestrial 
products  of  animal  origin  from 
animals 

certification 

and 

Certain empowerments of Regulation (EU) 2016/429 have not been used during the reporting 
period 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.  However,  the  Commission  is  assessing  the  need  to 
proceed with the preparation of specific acts to cover those aspects, especially in light of 
experience on the practical application of the new rules. 

  The  empowerments  in  Articles  18(3)  and  20(3)  related  to  disease  notification  and 
reporting were not used so far. Once Regulation (EU) 2016/429 becomes applicable, rules 
on their basis might be needed to address any implementation problem that may arise in 
Member States, or for the Commission. 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  of Article 68(3) concerning the restoration of disease free status 
for  certain  animal  diseases,  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.  

  A  delegated  act  on  Union  antigen,  vaccine  and  diagnostic  reagent  banks  using  the 
empowerment of Article 48(3) is in development and its adoption is planned in 2021. 

  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. 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  on  specific  types  of  movements  of  terrestrial  animals  laid  down  in 
Articles 138 and 139 were not used. Nevertheless, such rules providing further details may 
be  needed  after  the  date  of  application  of  Regulation  (EU)  2016/429  in  case  difficulties 
arise  in  the  implementation  of  those  provisions.  Similar  conditions  apply  for  the 
empowerments of Articles 200 and Article 204 on certain types of movements of aquatic 
animals and Article 214 as 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 so far, but it should be in a 
position to lay down animal health rules for such animals (e.g. reptiles, amphibians) when 

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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 need to gather more experience on the practical application of the new 
rules before deciding to develop such acts.  

  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. 

  The empowerments of Part VI (Articles 245 to 254) of Regulation (EU) 2016/429 on non-
commercial movements of pet animals were not used. In accordance with Article 277 the 
rules laid down in Part VI will only apply after 21 April 2026. The Commission will use 
those powers once Part VI starts applying. 

  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 is not yet applicable, 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 need to develop rules based on the empowerments 
will  remain  in  the  future.  This  will  be  particularly  important  to  provide  the  necessary 
flexibility  in  the  implementation  of  the  new  rules,  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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