COMMISSION STAFF WORKING DOCUMENT EVALUATION of Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) Accompanying the document REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the evaluation of Regulation (EU) 2016/429 on transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law')
Date: 2026-07-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal disease, disease prevention, epidemic, health risk, protection of animal life, veterinary inspection, veterinary medicine

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 6.7.2026  SWD(2026) 179 final  COMMISSION STAFF WORKING DOCUMENT  EVALUATION  of Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law)  Accompanying the document REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT on the evaluation of Regulation (EU) 2016/429 on transmissible animal diseases and amending and repealing certain acts in the area of animal health ('Animal Health Law') {COM(2026) 352 final}  
 
 
Table of contents 

Contents 
1. 

INTRODUCTION ................................................................................................................. 5 

1.1Scope…………. ..................................................................................................................... 5 

1.2 Methodology ........................................................................................................................ 6 

1.3 Limitations ........................................................................................................................... 7 

2. WHAT WAS THE EXPECTED OUTCOME OF THE INTERVENTION? ........................ 8 

2.1 Problem definition ............................................................................................................... 8 

2.2 Objectives ............................................................................................................................. 9 

2.3 AHL in practice ................................................................................................................. 12 

2.4 Interfaces with overlapping policy domains ................................................................... 17 

2.5 Point(s) of comparison ...................................................................................................... 20 

3.HOW HAS THE SITUATION EVOLVED?........................................................................... 22 

3.1 Sectoral background ......................................................................................................... 23 

3.2 Legal evolution and transitional phase (2016–2021) ...................................................... 24 

3.3 Implementation by the European Commission (2021 - 2024) ....................................... 25 

3.4 Implementation by Member States (2021–2024) ............................................................ 27 

3.5 Adaptation by operators ................................................................................................... 30 

3.6 Epidemiological context .................................................................................................... 31 

4.EVALUATION FINDINGS ...................................................................................................... 35 

4.1To what extent was the intervention successful and why? ............................................. 35 

4.1.1. Effectiveness .................................................................................................. 35 

4.1.2. Efficiency ...................................................................................................... 48 

4.1.3 Coherence ...................................................................................................... 59 

4.2 How did the EU intervention make a difference and to whom? ................................... 63 

4.3 Is the intervention still relevant? ..................................................................................... 66 

5.2 Lessons learned .................................................................................................................. 71 

ANNEX I. PROCEDURAL INFORMATION ........................................................................... 73 
ANNEX II. METHODOLOGY AND ANALYTICAL MODELS USED ................................ 75 

ANNEX  III.  EVALUATION  MATRIX  AND,  WHERE  RELEVANT,  DETAILS  ON 
ANSWERS TO THE EVALUATION QUESTIONS (BY CRITERION) ...................... 76 
ANNEX IV. OVERVIEW OF BENEFITS AND COSTS ....................................................... 118 
ANNEX V. STAKEHOLDER CONSULTATION - SYNOPSIS REPORT .......................... 126 

ANNEX  VI  ANIMAL  HEALTH  LAW  LEGAL  EVOLUTION  AND  TRANSITIONAL 
PHASE (2016-2021) .......................................................................................................... 141 

 
 
 
 
Glossary 

Term or acronym 

Meaning or definition 

ADIS 

AHL 

AMR 

ASF 

BSE 

BRG 

Animal Disease Information System 

Animal Health Law 

Antimicrobial Resistance 

African Swine Fever 

Bovine spongiform encephalopathy 

Better Regulation Guidelines 

BT/BTV 

Bluetongue (Bluetongue virus) 

BTSF 

BVD 

CBA 

CfE 

CPs 

CSF 

Better Training for Safer Food  

Bovine Viral Diarrhoea 

Cost-Benefit Analysis 

Call for Evidence 

Control Programmes  

Classical swine fever 

COMEXT 

External Trade Database 

CVO 

Chief Veterinary Officer 

DG SANTE 

Directorate General for Health and Food Safety 

 
 
EBL 

EC 

EEA 

EFSA 

EFTA 

EHD 

EMA 

EU 

Enzootic Bovine Leukosis  

European Commission 

European Economic Area 

European Food Safety Authority 

European Free Trade Association 

Epizootic Haemorrhagic Disease 

European Medicines Agency 

European Union 

EUROSTAT 

Statistical Office of the European Communities 

EUVET 

EU Veterinary Emergency Team 

FMD 

FVE 

HPAI 

Foot-and-mouth disease  

Federation of Veterinarians of Europe 

Highly Pathogenic Avian Influenza 

IA and DA 

Implementing and Delegated Act 

IBR 

IHN 

IT 

Infectious Bovine Rhinotracheitis  

Infectious Haematopoietic Necrosis 

Information Technology  

 
 
MS 

NCA 

NGO 

OCR 

PPR 

SPGP 

SME 

SPS 

Member State 

National Competent Authority 

Non-Governmental Organisation 

Official Control Regulation 

Peste des Petits Ruminants 

Sheep Pox and Goat Pox  

Small and Medium-sized Enterprise 

Sanitary and Phytosanitary Measures 

TRACES 

Trade Control and Expert System 

TSE 

WAHIS 

WOAH 

WTO 

Transmissible Spongiform Encephalopathies 

World Animal Health Information System  

World Organisation for Animal Health 

World Trade Organisation 

 
 
1. 

Introduction 

Transmissible animal diseases do not respect national borders. While they primarily affect 
animal  health,  agricultural  and  aquaculture  production,  some  also  pose  risks  to  human 
health and can generate significant economic and societal costs. For decades, the European 
Union has established harmonised rules to prevent and control such diseases. The first EU 
acts in the field date back to 1964, and the development of the Single Market in the 1990s 
further expanded and reinforced this regulatory framework. 

Regulation (EU) 2016/4291 on transmissible animal diseases, the ‘Animal Health Law’ or 
AHL,  adopted  in  2016,  fundamentally  modernised  this  framework.  It  replaced  39 
Directives and Regulations and established a single, coherent legal basis for EU animal 
health  policy.  Building  on  the  EU  Animal  Health  Strategy  2007–2013,  “Prevention  is 
better  than  cure”,  the  AHL  preserves  the  EU  internal  market  by  ensuring  high  animal 
health status and safe movements of animals and their products across the EU. It protects 
human  health  by  providing  measures  to  prevent  and  control  zoonotic  diseases  such  as 
tuberculosis, brucellosis, rabies or avian influenza. The AHL introduced a more risk-based 
and  preventive  approach,  strengthened  disease  preparedness  and  surveillance,  clarified 
responsibilities of operators and authorities, while integrating the One Health perspective. 
It  also  sought  to  simplify  legislative  structure  and  enhance  flexibility  to  respond  to 
emerging and evolving threats. 

The AHL lays down  rules for the prevention and control of listed transmissible animal 
diseases, for the traceability and registration of animals and establishments, and for animal 
health requirements governing movements within the Union and entry into the Union of 
animals and their products. It is complemented by a comprehensive set of delegated and 
implementing acts that operationalise its core provisions. In accordance with Article 282 
of the AHL, the Commission is required to evaluate the Regulation. This evaluation fulfils 
that legal obligation by assessing the extent to which the AHL has achieved its objectives 
since entering into force on 21 April 2016, with a particular focus on the application since 
21 April 2021 until the completion of the evaluation report. 

The  evaluation  assesses  the  five  compulsory  Better  Regulation  criteria:  effectiveness, 
efficiency, relevance, coherence, and EU added value (see Annex III for the evaluation 
matrix). It assesses whether the Regulation has delivered a single EU animal health policy 
based on prevention and risk prioritisation, clarified roles and responsibilities, improved 
preparedness  and  response,  facilitated  safe  trade,  and  contributed  to  simplification  and 
proportionality. The findings of this evaluation are intended to inform future Commission 
action, including potential review, targeted adjustment or simplification of the AHL and 
its delegated acts. 

1.1  Scope 

The  evaluation  covers  the  interventions  established  by  Regulation  (EU)  2016/429  and 
together with the delegated acts referred to in Article 264. Between 2020 and 2024, 13 
delegated  acts  were  adopted  to  operationalise  the  Regulation,  several  of  which  were 

1  

Regulation  (EU)  2016/429  of  the  European  Parliament  and  of  the  Council  of  9  March  2016  on 
transmissible animal diseases and amending and repealing certain acts in the area of animal health ( 
Animal Health Law), http://data.europa.eu/eli/reg/2016/429/2016-03-31. 

5 

 
 
already amended during this period. Where certain implementing acts are essential for the 
functioning  of  the  AHL  framework,  they  are  also  considered,  insofar  as  necessary,  to 
ensure a comprehensive assessment of the overall legal architecture. 

The evaluation examines how the AHL framework operates in practice regarding terrestrial 
and aquatic animals, across the following core areas: 

•  prioritisation and categorisation of animal diseases of Union concern; 
•  early  detection,  notification  and  reporting  of  diseases,  surveillance,  eradication 

programmes and disease–free status;  

•  disease awareness, preparedness and control;   
• 

registration  and  approval  of  establishments  and  transporters,  identification  and 
registration of animals, and traceability of products thereof; 

•  movements of terrestrial and aquatic animals, germinal products and in certain cases 

of products of animal origin within the Union;  

•  entry into the Union of animals, germinal products, and products of animal origin and 

the export of such consignments from the Union;  

•  non–commercial movements of pet animals into a Member State from another Member 

State or from a third country or territory; and  

•  emergency measures to be taken in the event of a disease emergency situation.  

The  timeframe  covered  extends  from  the  adoption  of  the  AHL  in  2016  to  2024,  with 
particular focus on the  period since its application on 21  April 2021. The geographical 
scope  encompasses  all  EU  Member  States.  Where  relevant,  reference  is  also  made  to 
European Economic Area (EEA) countries and EU candidate countries.  

The  evaluation  was  supported  by  an  external  study  contracted  by  the  European 
Commission  (DG  SANTE)  and  supervised  by  an  Inter-Service  Coordination  Group 
(ISCG) chaired by DG SANTE, with participation from other relevant services. The ISCG 
ensured  methodological  robustness,  coordination  across  services  and  consistency  with 
Better Regulation standards. 

The  evaluation  excludes  matters  governed  by  separate  legal  frameworks  and  therefore 
falling  outside  the  scope  of  the  AHL.  These  include,  in  particular,  transmissible 
spongiform  encephalopathies  (TSE), zoonoses monitoring, zootechnics, animal  welfare, 
veterinary medicinal products  and  residues, and  feed and  food safety  in  general. While 
these EU policy  areas  naturally  shape the broader regulatory environment  in  which the 
AHL operates, these are not assessed in their own right. They are considered solely for the 
purpose of assessing coherence, and only insofar as their provisions interact directly with 
the implementation of animal health rules. 

Further procedural details, including the composition of the ISCG, the evaluation timeline, 
and details regarding the external contract are presented in Annex I. 

1.2  Methodology 

The  evaluation  was  conducted  using  a  mixed-methods  approach,  combining  qualitative 
and quantitative analysis. Given the complexity and breadth of the AHL framework, the 

6 

 
methodology  was  designed  to  assess  both  the  legal  architecture  and  its  practical 
implementation across Member States2. The main analytical components included: 

-  desk  research,  including  systematic  review  of  the  AHL  and  its  delegated  and 
relevant  implementing  acts,  as  well  as  analysis  of  the  evolution  of  the  legal 
framework since 2016; 

- 

-  quantitative analysis of disease, surveillance and trade data,  drawing on key EU 
information systems, in particular IMSOC including ADIS and TRACES NT, as 
well as scientific data from  EFSA, COMEXT and Eurostat. This  included  trend 
analysis and cross-country comparisons where appropriate; 
targeted stakeholder consultations, including surveys, interviews and case studies, 
covering  competent  authorities,  business  operators,  veterinarians,  laboratories, 
professional associations, NGOs and academic experts across Member States; 
comparative  analysis  of  national  implementation,  including  control  systems, 
enforcement practices, biosecurity requirements, preparedness, taking into account 
differences  in  epidemiological  contexts  across  Member  States  and  non-EU 
countries; and 
triangulation of findings, combining legal analysis, stakeholder evidence, scientific 
opinions, e.g. from EFSA, outbreak reports, audit findings, and relevant economic 
literature. 

- 

- 

In addition, the evaluation considered lessons learned from recent disease events, which 
provided  real-world  tests  of  the  functioning  of  surveillance  systems,  biosecurity 
obligations, emergency preparedness mechanisms, and operator responsibilities. 

The evidence sources included EU databases and reports, surveillance and outbreak data, 
EFSA opinions, Commission audits, stakeholder input, and detailed external study . 

Where  data  gaps  existed,  the  evaluation  relied  on  plausible  stakeholder  indications  and 
assumptions, which were validated through the consultation processes wherever possible. 

1.3  Limitations 

The  evaluation  was  conducted  at  a  relatively  early  stage  of  the  AHL’s  application. 
Although the Regulation entered into force in 2016, it has applied only since 21 April 2021. 
As  a  result,  full  alignment  of  national  legislation  and  administrative  systems  remains 
ongoing in several Member States. The assessment therefore reflects an implementation 
phase that is still evolving. 

Timing and data constraints: the limited duration of application restricts the observation 
of  longer-term  effects,  particularly  those  related  to  structural  prevention,  behavioural 
change and resilience. The completeness and comparability of data across Member States 
vary  and  were  in  some  cases  affected  by  delays  in  the  adoption  or  implementation  of 
delegated  and  implementing  acts.  During  the  reference  period,  pre-existing  national 
provisions often continued to operate alongside AHL requirements. This overlap makes it 
difficult to isolate impacts that can be attributed exclusively to the AHL. 

Analytical constraints: the consolidation of the legal framework and the introduction of 
new governance and risk-based mechanisms required adaptation of national systems. As 
legacy  national  approaches  remained  in  place  during  this  transition,  this  limits  the 
assessment of the full operational effects of the AHL in a stable regulatory environment. 

2  

The key assumptions and methodological considerations are detailed in Annex II. 

7 

 
 
Scientific and analytical factors: the AHL’s preventive and risk-based design is intended 
to  generate  effects  that  materialise  over  time,  including  improved  preparedness,  earlier 
detection  and  strengthened  biosecurity  practices.  Such  outcomes  depend  on  complex 
epidemiological, behavioural and institutional dynamics. Several indicators are influenced 
by  external  drivers,  including  evolving  disease  patterns,  global  trade  developments  and 
geopolitical events. Quantitative data on administrative costs and benefits, particularly in 
relation  to  prevention  and  biosecurity,  remain  incomplete  and  in  some  cases  rely  on 
qualitative evidence. 

Operational  pressures:  implementation  during  the  reference  period  coincided  with 
significant animal health events, including unprecedented outbreaks of highly pathogenic 
avian influenza (HPAI), African swine fever (ASF) and the expansion of bluetongue virus 
(BTV), as well as  the COVID-19 pandemic. These events  placed sustained pressure on 
national  authorities  and  may  have  affected  both  implementation  timelines  and  the 
availability  of  evidence.  Stakeholders  also  highlighted  the  difficulty  of  distinguishing 
effects  attributable  to  the  AHL  from  broader  transitional  dynamics  or  independently 
evolving national legislation. 

To  mitigate  these  limitations,  the  evaluation  triangulated  evidence  across  multiple  data 
sources  and  stakeholder  groups,  complemented  gaps  with  case  studies  and  validation 
workshops.  Taken  together,  these  limitations  mean  that  the  evaluation  should  be 
interpreted as an early-stage assessment of implementation progress and emerging trends, 
rather  than  as  a  definitive  appraisal  of  long-term  impacts.  A  more  comprehensive 
assessment  of  structural  effects,  including  cost-efficiency  and  resilience  outcomes,  will 
require additional time and more mature data following full stabilisation of implementation 
across Member States. 

2.   What was the expected outcome of the intervention? 

2.1   Problem definition 

Before the adoption of the AHL, the Union’s animal health framework consisted of a large 
number  of  Directives,  Decisions  and,  to  a  more  limited  extent,  Regulations  addressing 
specific diseases or thematic areas. These instruments had developed incrementally over 
several  decades  and  differed  in  structure,  terminology  and  level  of  detail.  As  a  result, 
implementation across Member States was fragmented and uneven, leading to variations 
in preventive practices, surveillance systems and reporting arrangements. 

The  pre-existing  framework  was  predominantly  reactive,  with  a  strong  focus  on  post-
outbreak response. Provisions on prevention, preparedness and biosecurity were limited or 
inconsistently harmonised. Contingency planning and early detection mechanisms varied 
between  Member  States,  and  there  was  no  structured  system  for  disease  prioritisation, 
listing or categorisation at Union level. 

Differences also existed in national responses to disease suspicion or confirmation, as well 
as  in  certain  areas  of  animal  identification,  movement  controls,  registration  of 
establishments and traceability. Surveillance methodologies were not always comparable, 
and administrative procedures could be duplicative or burdensome. 

8 

 
At the same time, increasing pressure from transboundary animal diseases, including ASF 
and HPAI, highlighted the substantial animal health, public health and economic impacts 
of  large-scale  outbreaks.  Disease  events  demonstrated  the  need  for  more  coherent 
preparedness, rapid response mechanisms and coordinated action across the Union. 

From a trade perspective, rules governing intra-Union movements were dispersed across 
multiple legal acts and were often rigid and difficult to update. As many provisions were 
embedded  in  Directives  adopted  by  the  Council  or  co-legislated  with  the  European 
Parliament, adapting them to evolving epidemiological realities or international standards 
was complex and time-consuming. Import requirements were likewise scattered and not 
always  transparent,  in  some  cases  being  specified  primarily  through  certification 
statements rather than consolidated legal provisions describing health requirements. 

Taken  together,  the  multiplicity  of  disease-specific  instruments  and  the  absence  of  a 
consolidated  legal  framework  resulted  in  a  lack  of  a  clearly  defined,  single  EU  animal 
health policy based on common principles and prioritisation. 

2.2   Objectives 

Against  this  background,  Regulation  (EU)  2016/429  established  a  single,  risk-based 
regulatory  framework  governing  the  prevention  and  control  of  animal  diseases 
transmissible to animals and, where relevant, to humans. It constitutes the core legislative 
instrument implementing the EU Animal Health Strategy 2007–2013 (“Prevention is better 
than cure”), reflecting a policy shift towards a more preventive, science-based and coherent 
Union framework. Its general intervention logic is illustrated in Figure 1 below. 

The general  objective of the AHL is  to  ensure a high  level  of animal  health  within  the 
Union, 
thereby  supporting  sustainable  agricultural  and  aquaculture  production, 
contributing  to  public  health  protection  and  food  security,  and  safeguarding  the  proper 
functioning of the internal market. 

To achieve this general objective, the AHL pursues the following specific objectives: 

•  establish a single, simplified, transparent and coherent regulatory framework, replacing 

• 

the previously fragmented disease-specific legislation; 
introduce  a  structured  system  for  disease  listing,  prioritisation  and  categorisation  to 
enable proportionate, risk-based measures; 

•  strengthen prevention and preparedness through reinforced biosecurity obligations,  
•  surveillance systems and vaccination frameworks; 
•  clarify  and  rebalance  the  roles  and  responsibilities  of  operators,  veterinarians  and 

competent authorities; 

•  ensure that disease-control measures are proportionate, science-based and aligned with 

• 

relevant international standards; 
improve flexibility and adaptability of the framework to emerging risks and evolving 
epidemiological situations; 

•  enhance coherence with related Union policies, including animal welfare, food safety 

• 

and public health; and 
reduce  the  socio-economic  impact  of  animal  diseases  and  minimise  unjustified  or 
disproportionate disruptions to intra-Union and international trade. 

9 

 
The Regulation lays down harmonised rules covering  

•  prevention,  early  detection,  notification,  surveillance,  control  and  eradication  of 

listed diseases;  
registration and approval of establishments and transporters;  
identification and traceability of animals and germinal products;  

• 
• 
•  movement requirements within the Union;  
•  entry into and export from the Union;  
•  non-commercial movements of pet animals; and  
•  emergency measures in case of serious disease situations.  

In pursuing these objectives, the AHL adopts an integrated approach consistent with the 
One  Health  perspective,  recognising  the  interlinkages  between  animal  health,  public 
health,  food  and  feed  safety,  antimicrobial  resistance,  animal  welfare,  biodiversity  and 
climate-related risks.  

Figure 1: AHL General intervention logic

10 

 
 
11 

 
 
2.3   AHL in practice 

Scope and overall architecture 

The  AHL  establishes  a  comprehensive  and  harmonised  legal  framework  for  the 
prevention and control of animal diseases transmissible to animals and, where relevant, 
to  humans.  Its  scope  covers 
terrestrial  and  aquatic  animals,  wildlife  where 
epidemiologically  relevant,  germinal  products  and  other  products  of  animal  origin,  as 
well as operators, establishments, and movements within the Union and entry from third 
countries. 

The Regulation applies across all Member States and, where relevant, EEA countries. It 
integrates  prevention,  preparedness,  surveillance,  control,  trade  and  traceability 
requirements within a single regulatory structure, replacing a fragmented body of disease-
specific  legislation  that  had  developed  incrementally  over  several  decades.  The 
intervention logic of the AHL is structured around a dual-layer architecture: 

The first layer consists of horizontal, general animal health rules that apply irrespective 
of the disease situation. These include clearly defined responsibilities for operators and 
competent authorities, biosecurity obligations, requirements for registration and approval 
of establishments, and systems for identification and traceability. This baseline layer is 
designed to ensure continuous prevention and a minimum level of preparedness across 
the Union. 

The second layer consists of disease prevention and control measures triggered through a 
structured  system  of  listing  and  categorisation  of  animal  diseases.  Diseases  of  Union 
concern  are  assessed  according  to  harmonised  criteria  and  assigned  to  categories 
reflecting  the  level  of  intervention  required.  This  enables  proportionate,  risk-based 
application of surveillance, eradication and control measures. 

Together, these two layers create a framework in which general prevention applies at all 
times,  while  additional  measures  are  activated  according  to  epidemiological  risk.  The 
architecture  is  intended  to  ensure  coherence,  proportionality  and  predictability  in  the 
Union’s approach to preventing, detecting and controlling transmissible animal diseases. 

2.3.1   Structured disease listing and categorisation 

A central innovation of the AHL is the establishment of a harmonised system for listing 
and  categorising  animal  diseases  of  Union  concern.  Under  the  previous  legislative 
framework, triggers for Union intervention were dispersed across multiple instruments 
and lacked a unified structure, which limited transparency and consistency. 

The AHL introduces a single framework for identifying diseases requiring Union action 
and assigning them to categories reflecting the level of intervention considered necessary. 
Categorisation  is  determined  by  the  nature  and  intensity  of  measures  to  be  applied, 
including surveillance obligations, disease control measures, eradication programmes and 
disease-free  status  requirements.  The  listing  and  categorisation  process  is  based  on 
harmonised risk criteria and informed by scientific assessment, with periodic review to 
ensure alignment with evolving epidemiological and scientific developments. 

12 

 
Within this system, the Commission adopts and updates the lists and the associated rules, 
while  primary  Member  States  implement  the  measures  corresponding  to  each  disease 
category  and  report  their  disease  status.  By  linking  intervention  levels  directly  to  risk 
assessment  and  predefined  criteria,  the  framework  is  intended  to  ensure  robustness, 
proportionality,  adaptability, 
improve  prioritisation  of  resources  and  enhance 
predictability in Union action. 

The expected outcomes of this pillar are clearer prioritisation of diseases requiring Union 
intervention, more targeted and risk-based prevention and control measures and increased 
legal certainty for competent authorities and operators regarding the obligations triggered 
by each disease category. 

2.3.2   Early detection, surveillance and disease-free status 

The  AHL  establishes  a  harmonised  framework  for  early  detection,  notification  and 
reporting  of  listed  diseases,  supported  by  structured  surveillance  systems,  eradication 
programmes and rules governing the granting and maintenance of disease-free status. 

Member States are responsible for designing and implementing surveillance systems in 
accordance  with  harmonised  requirements,  while  operators  are  subject  to  defined 
obligations to notify suspected cases without undue delay and ensure own surveillance in 
their establishments. The framework clarifies the respective roles of operators, official 
veterinarians and  competent  authorities in  sampling,  diagnosis  and reporting.  National 
and Union reference laboratories contribute to  methodological  consistency and quality 
assurance, while the Commission supports coordination and comparability at Union level. 

Surveillance  requirements  include  case  definitions,  minimum  sampling  standards, 
notification  deadlines  and  information-sharing  obligations.  Where  epidemiologically 
relevant,  surveillance  may extend  to wildlife. This  architecture is  intended to  improve 
comparability of surveillance outputs across Member States and strengthen the reliability 
of disease reporting. 

The  expected  outcomes  of  this  pillar  are  earlier  detection  and  confirmation  of  suspect 
cases, more timely and consistent notifications, enhanced transparency of disease status 
and more robust foundations for eradication programmes and the recognition or recovery 
of disease-free status. 

2.3.3   Strengthening prevention through biosecurity and vaccination 

A core objective of the AHL is to shift the Union’s animal health framework towards a 
stronger preventive orientation. Prevention is supported through reinforced biosecurity 
obligations,  structured  surveillance,  mandatory  animal  health  visits  and  a  revised 
approach for vaccination. 

Operators  are  required  to  apply  general  and  activity-specific  biosecurity  measures 
appropriate to the risks associated with their activities. Mandatory animal health visits are 
intended to support early detection and promote continuous improvement of biosecurity 
practices at establishment level. Competent authorities are responsible for oversight and 
enforcement,  ensuring  that  preventive  obligations  are  applied  consistently  across  the 

13 

 
Union. This  clearer allocation of responsibilities is designed to  embed prevention as a 
shared and continuous obligation rather than a reactive response to outbreaks. 

The AHL also introduces a revised approach to vaccination.  It provides a broader and 
more flexible legal framework allowing vaccination to be used not only as an emergency 
control  tool but also, where appropriate, as a preventive measure. The framework sets 
conditions for vaccination strategies and enables the establishment of Union antigen and 
vaccine banks to support coordinated responses where necessary. 

The  expected  outcomes  of  this  pillar  are  strengthened  biosecurity  practices  at 
establishment level, enhanced preparedness through systematic preventive measures, and 
greater flexibility for Member States to deploy vaccination strategies in a risk-based and 
proportionate manner. 

2.3.4   Disease preparedness and emergency response 

The  AHL  reinforces  the  Union’s  framework  for  disease  awareness,  preparedness  and 
outbreak  response  by  establishing  common  principles  and  minimum  requirements 
applicable across Member States. It emphasises preparedness as a continuous obligation, 
requiring systems and procedures to be in place before the occurrence of disease events. 

Member  States  are  required  to  take  disease  control  measures  in  accordance  with  the 
harmonised  rules  setting  out  how  outbreaks  are  to  be  managed,  while  disease 
categorisation determines the applicable level of intervention. Control measures, such as 
stamping-out, cleaning and disinfection, and, where appropriate, vaccination, are applied 
in  accordance  with  predefined  conditions.  These  are  accompanied  by  post-outbreak 
surveillance and structured procedures for lifting restrictions and recovering disease-free 
status. The framework enables competent authorities to delineate restricted and infected 
zones on the basis of harmonised principles and epidemiological assessment. 

To that end Member States are also required to establish, maintain and periodically test 
contingency  plans  for  certain  listed  diseases,  including  through  simulation  exercises. 
Operators and veterinarians have defined roles in disease awareness, early detection and 
initial  response.  The  Commission  supports  coordination  at  Union  level,  drawing  on 
scientific advice to ensure that control measures are risk-based and proportionate. 

By  linking  categorisation  to  predefined  disease  control  measures  and  response  tools 
including  establishing  clear  conditions  for  setting  up  and  lifting  restrictions  and 
recovering  disease-free  status,  the  framework  is  designed  to  enhance  legal  clarity  and 
predictability during crisis situations. 

The expected outcomes of this pillar are better overall preparedness of Member States, 
more predictable disease control rules with enhanced capacity to contain disease spread 
during outbreaks, enabling faster and more coordinated responses to disease events, more 
consistent  application  of  control  measures  across  Member  States,  and  mitigation  of 
adverse 
trade,  while  avoiding 
disproportionate disruption. 

impacts  on  animal  health,  public  health  and 

14 

 
2.3.5   Registration, approval and traceability 

The  AHL  establishes  a  structured  framework  for  the  registration  and  approval  of 
operators and establishments, as well as for the identification and traceability of animals, 
germinal  products  and  products  of  animal  origin.  These  elements  form  a  foundational 
component of disease prevention and control by enabling competent authorities to trace 
movements and apply measures effectively. 

Activities falling within the scope of the Regulation are subject to registration or approval, 
accompanied  by  defined  record-keeping  obligations.  Competent  authorities  are 
responsible for maintaining registers, taking decisions on approval, and, where necessary, 
suspending  or  withdrawing  authorisations  in  accordance  with  criteria  laid  down  in 
delegated and implementing acts. The framework applies to establishments and operators 
whose activities present epidemiological relevance. 

Identification systems and movement documentation requirements are aligned with risk-
based official controls, ensuring that traceability obligations correspond to the level of 
risk associated with different activities. The framework also provides for proportionate 
arrangements and defined derogations in low-risk situations. 

The expected outcomes of this pillar are improved transparency regarding operators and 
establishments, strengthened traceability across the supply chain, enhanced capacity to 
manage  disease  risks  linked  to  movements,  and  increased  mutual  confidence  between 
Member  States  in  the  consistent  application  of  animal  health  requirements  within  the 
internal market. 

2.3.6   Movements within the Union 

The AHL establishes harmonised animal health requirements for movements of animals, 
germinal products and products of animal origin within the Union. These requirements 
are based on identification and record-keeping rules, defined movement conditions for 
listed  disease  and  specific  animal  species  and  categories  as  well  as  proportionate 
arrangements for low-risk situations. These movement requirements are aligned with the 
relevant international standards of the World Organisation for Animal Health (WOAH). 

Transport operators are subject to defined cleaning and disinfection obligations to reduce 
the risk of disease spread during movement. In the event  of outbreaks,  the framework 
provides for temporary restrictions, zoning and channelling measures designed to manage 
movements in accordance with the epidemiological situation. 

Harmonised  attestations  and  certification  requirements  support  traceability  and  enable 
competent authorities to verify compliance. The expected outcomes of this pillar are safe, 
predictable  and  proportionate  movement  rules  across  the  Union,  safeguarding  animal 
health across in the Union and ensuring smooth operation of the internal market through 
the consistent application of animal health requirements. 

15 

 
 
 
2.3.7   Entry into and export from the Union 

The  AHL  establishes  a  harmonised  framework  governing  the  entry  into  the  Union  of 
animals, germinal products and products of animal origin, as well as the export of such 
consignments. The objective is to ensure that imported consignments meet animal health 
requirements  equivalent  to  those  applicable  to  movements  within  the  Union,  thereby 
maintaining a consistent level of protection. 

Under this framework, the Commission defines entry conditions, establishes and updates 
lists  of  authorised  third  countries  or  regions,  recognises  regionalisation  where 
appropriate,  and  adopts  model  health  certificates.  The  system  provides  structured  and 
transparent  requirements  across  different  commodities,  reflecting  harmonised  animal 
health guarantees. 

The framework operates in accordance with the WTO Agreement on the Application of 
Sanitary  and  Phytosanitary  Measures  (SPS  Agreement)  and  is  aligned  with  relevant 
international standards, including those of the WOAH. It allows, where appropriate, for 
the  recognition  of  equivalence  and  regionalisation,  supporting  risk-based  trade 
management. 

The expected outcomes of this pillar are credible and transparent management of external 
disease risks, strengthened confidence in the Union’s animal health guarantees, and stable 
and predictable trade conditions based on clear and consistent requirements. 

2.3.8   Non-commercial movements of pet animals 

The  AHL  establishes  a  harmonised  framework  governing  the  non-commercial 
movements of pet animals between Member States and from third countries or territories. 
These provisions complement the general movement rules applicable to animals, while 
addressing the specific context of animals accompanying their owners. 

The  framework  sets  conditions  relating  to  identification,  health  requirements  and 
accompanying documentation, with the objective of ensuring a high level of protection 
for  animal  and  public  health  while  facilitating  legitimate  movements.  Competent 
authorities  are  responsible  for  verifying  compliance  with  these  requirements,  and  the 
Commission  adopts  implementing  measures  to  support  uniform  application  across 
Member States. 

The provisions governing non-commercial movements of pet animals apply from April 
2026.  As  these  rules  were  not  yet  applicable  within  the  evaluation  period,  their 
implementation and effects cannot be assessed at this stage and are outside the scope of 
this evaluation. 

2.3.9   Emergency measures and regionalisation 

Emergency  measures  applicable  for  certain  diseases,  including  the  structured  use  of 
regionalisation  in  the  event  of  a  disease  outbreak  are  amongst  crucial  elements  of  the 
AHL. Regionalisation allows control measures to  be geographically targeted, focusing 

16 

 
restrictions on affected areas while permitting movements from unaffected zones subject 
to  defined  conditions.  This  risk-based  differentiation  is  designed  to  support  effective 
disease containment while maintaining continuity of trade within the Union and with third 
countries. 

Emergency response under the AHL is based on harmonised Union rules complemented 
by Member States’ contingency plans, which define command structures, resources and 
communication arrangements. 

The expected outcomes of this pillar are coherent and coordinated outbreak management 
across  Member  States,  limitation  of  disease  spread  through  geographically  targeted 
measures, and a transparent and predictable pathway for restoring regular movement and 
trade conditions. 

2.4   Interfaces with overlapping policy domains 

Before  the  adoption  of  the  AHL,  animal  health  rules  were  dispersed  across  multiple 
disease- and sector-specific instruments, with varying degrees of interaction with food 
safety, zoonoses, official controls and other SPS legislation. These links existed but were 
not embedded in a unified risk-based structure. 

The AHL establishes a single framework for animal disease prevention and control while 
operating alongside specialised Union legislation addressing specific sectors or risks. It 
does not replace these instruments but is designed to function in coordination with them, 
ensuring consistency while respecting distinct legal mandates. 

Interaction within the food chain framework 

The AHL is closely linked to the Official Controls Regulation (OCR, Regulation (EU) 
2017/6253)  which  provides  the  horizontal  framework  for  verification  and  enforcement 
across  the  food  chain.  While  the  AHL  sets  animal  health  obligations  and  control 
measures, the OCR governs how compliance is verified, including laboratory systems, 
delegation  of  tasks  and  cooperation  between  competent  authorities.  This  institutional 
alignment is intended to support uniform implementation across Member States. 

The  AHL  also  operates  alongside  the  General  Food  Law4  and  related  food  safety 
legislation.  By  addressing  disease  risks  at  animal  and  farm  level,  the  AHL  functions 
upstream of food safety law, reducing risks before they enter the food chain. Food and 
feed hygiene legislation establishes baseline hygiene obligations for primary production. 
The AHL complements these provisions by addressing biosecurity specifically from an 
animal  health  perspective,  linking  preventive  measures  directly  to  disease  control 
objectives. 

3  

4  

Regulation (EU) 2017/625 of the  European Parliament and of the Council of 15 March 2017 on 
official controls and other official activities performed to ensure the  application of food and feed 
law,  rules  on  animal  health  and  welfare,  plant  health  and  plant  protection  products, 
http://data.europa.eu/eli/reg/2017/625/oj. 
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 
laying down the general principles and requirements of food law, establishing the European Food 
Safety  Authority 
safety, 
and 
http://data.europa.eu/eli/reg/2002/178/2026-01-01. 

in  matters 

procedures 

laying 

down 

food 

of 

17 

 
 
18 

 
 
 
Veterinary medicinal products and residues 

The AHL interacts with legislation governing veterinary medicinal products and residues 
where vaccines or treatments form part of disease prevention and control strategies. The 
authorisation, use and monitoring of veterinary medicines remain governed by dedicated 
legislation,  while  the  AHL  defines  the  disease  control  context  in  which  such  tools, 
particularly vaccination, may be deployed. 

Environmental and wildlife legislation 

The AHL applies to wildlife only where epidemiologically relevant for the prevention 
and  control  of  listed  diseases.  Measures  may  include  surveillance,  notification  and 
targeted control actions where necessary to protect animal or public health. Broader issues 
relating  to  wildlife  conservation,  habitat  protection  or  population  management  remain 
governed  by  environmental  legislation.  The  interaction  is  therefore  operational  rather 
than regulatory in scope. 

Public health  

The AHL interacts with Union public health legislation within a One Health approach.  
This includes links with Regulation (EU) 2022/23715 on serious cross-border threats to 
health,  supporting  coordinated  risk  assessment,  information  exchange  and  response, 
while respecting the different roles of each legal framework. 

Surveillance  and  data  exchange  mechanisms  are  designed  to  facilitate  coordination 
between animal health and public health authorities. This also includes surveillance in 
animals designed in a manner that it can inform public health authorities to take actions 
on  the  human  health  side,  where  necessary.  This  role  supports  coordinated  risk 
assessment, information exchange and response between animal health and public health 
authorities, strengthening overall preparedness and crisis management while respecting 
the different roles of each legal framework.  

Financial and crisis instruments 

The  AHL  establishes  obligations  relating  to  surveillance,  control  and  emergency 
measures  but  does  not  itself  regulate  Union  financial  instruments.  Implementation  of 
disease prevention and control measures may be supported through Union co-financing 
mechanisms and crisis instruments, which operate under separate legal bases. 

Animal breeding rules 

Animal breeding legislation governs breeding standards and trade in breeding animals, 
while operating in parallel with animal health requirements under the AHL. 

Disease areas regulated outside the AHL 

Certain  disease  areas  remain  governed  by  specific  legislation  due  to  their  distinct  risk 
profiles.  Rules  on  transmissible  spongiform  encephalopathies  (TSEs)  and  animal  by-
products  (ABPs) are laid  down in  dedicated instruments, with  the AHL applying only 
where  disease-control  measures  generate  operational  links,  e.g.  culling,  disposal  or 

5  

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2371. 

19 

 
 
movement restrictions. Similarly, zoonoses legislation governs rules, operating in parallel 
with animal health requirements under the AHL. 

Overall, the AHL is designed to integrate animal health policy within the broader Union 
regulatory  framework,  ensuring  coordination  with  related  domains  while  maintaining 
clear legal boundaries and avoiding duplication of regulatory objectives. 

Animal welfare rules 

The AHL does not contain provisions which regulate animal welfare. Animal welfare is 
regulated  in  a  separate  set  of  legislation.  That  legislation  operates  alongside  and 
independently of the animal health rules. 

However, the AHL recognises that animal health and welfare are linked: better animal 
health  promotes  better  animal  welfare,  and  vice  versa.  When  disease  prevention  and 
control  measures  are  carried  out  in  accordance  with  the  AHL  their  effect  on  animal 
welfare should be considered in order to spare the animals concerned any avoidable pain, 
distress or suffering. But the rules laid down in the AHL should not duplicate, or overlap 
with, the rules laid down in that animal welfare legislation6. 

2.5   Point(s) of comparison 

Legal framework before 2016 

Prior to the adoption of the AHL, the Union's animal health framework  consisted of a 
large number of disease-specific  or species-specific  directives, decisions and a  limited 
number  of  regulations  adopted  incrementally  over  several  decades.  These  instruments 
varied in structure, terminology and level of detail. Their transposition into national law 
led to differences in implementation and interpretation across Member States, resulting 
in a fragmented regulatory landscape. 

Surveillance and notification practices were not governed by a unified framework. Case 
definitions, sampling strategies and reporting requirements were in some instances absent 
from Union legislation or applied differently at national level. Notification timelines and 
laboratory  quality  standards  were  not  fully  harmonised,  limiting  comparability  of 
surveillance outputs. 

Rules concerning identification, traceability and movements were partially harmonised 
but  differed  across  species  and  sectors.  Documentation  requirements  varied,  and 
movement conditions were often embedded in rigid legislative provisions. Registration 
and  approval  procedures  for  operators  and  establishments  were  governed  by  differing 
national approaches, including variations in thresholds for registration, approval criteria 
and publication of registers. 

Preparedness  and  response  arrangements  also  displayed  heterogeneity.  Contingency 
planning, simulation exercises, zoning and regionalisation practices were not embedded 
within  a  single  structured  framework.  Preventive  tools  such  as  biosecurity  and 
vaccination were addressed in a more limited or fragmented manner. The need for a more 

6  

EU animal welfare legislation - Food Safety - European Commission. 

20 

 
 
integrated  and  preventive  approach  had  been  identified  in  earlier  policy  reflections, 
including the Animal Health Strategy 2007–2013. 

Overall, the pre-2016 framework provided substantive disease control tools but lacked a 
unified architecture linking prevention, surveillance, preparedness, trade and governance 
mechanisms within a coherent, risk-based system. 

Epidemiological situation prior to 2016 

Prior to the adoption of the AHL in 2016, the epidemiological situation in the Union was 
characterised  by  the  continued  management  of  long-standing  transboundary  diseases 
alongside the emergence and geographical expansion of new threats. The period reflected 
both the legacy of earlier major crises and evolving epidemiological dynamics influenced 
by wildlife reservoirs, vector distribution and cross-border transmission. 

Earlier large-scale crises had largely been stabilised. Bovine spongiform encephalopathy 
(BSE),  which  peaked  in  the  United  Kingdom  in  1996–1997,  had  been  progressively 
brought  under  control  through  stringent  Union  measures  adopted  from  2001  onwards, 
resulting in a substantial decline in cases and the achievement of negligible risk status in 
most  Member  States.  The  foot  and  mouth  disease  (FMD)  epidemic  in  the  United 
Kingdom  in  2001  was  subsequently eradicated,  demonstrating the  importance of strict 
surveillance  and  rapid  containment.  Meanwhile,  Classical  swine  fever  (CSF)  had  also 
disappeared from domestic pig populations, following coordinated eradication efforts in 
many EU Member States. 

From  the  mid-2000s  onwards,  new  epidemiological  patterns  emerged.  Vector-borne 
diseases also expanded geographically during this period. Bluetongue virus (BTV) - BTV 
8 was first detected in the Netherlands during the 2006–2008 epidemic and spread rapidly 
across Europe. Rabies in parallel significantly pushed out of the EU mainly by intense 
oral vaccination campaigns of wildlife. 

More  recently,  new  incursions  and  spread  of  transboundary  diseases  occurred.  ASF 
entered  the  Union  in  2014,  with  confirmed  cases  in  wild  boar  and  domestic  pigs  in 
Lithuania,  Latvia,  Estonia  and  Poland.  In  subsequent  years,  the  disease  extended  to 
additional Member States, including the Czech Republic and Romania in 2017, Hungary, 
Belgium and Bulgaria in 2018, and Slovakia in 2019. The epidemiology of ASF during 
this period was characterised by significant  involvement of wild  boar populations and 
repeated  risk  of  re-introduction  from  neighbouring  third  countries.  LSD  emerged  in 
south-eastern  Europe  in  2015–2016,  marking  its  introduction  into  the  Union  and 
highlighting the role of vector transmission and cross-border spread. 

HPAI  occurred  in  recurrent  epidemic  waves,  typically  associated  with  migratory  wild 
birds  and  seasonal  patterns.  While  outbreaks  required  substantial  control  efforts, 
circulation patterns were largely linked to seasonal dynamics and wildlife interfaces. 

These  developments  illustrated  the  increasing  relevance  of  wildlife  reservoirs,  vector 
ecology and cross-border epidemiological drivers. Overall, the epidemiological context 
prior  to  2016  combined  successful  containment  of  certain  historic  crises  with  the  re-
emergence and geographical expansion of other transboundary and vector-borne diseases, 
forming part of the policy environment in which the AHL was adopted. 

21 

 
3.How has the situation evolved? 

The  AHL  establishes  the  Union’s  framework  for  the  prevention  and  control  of 
transmissible animal diseases. It applies across the food chain and governs how animal 
health risks are prevented, detected and managed within the Union. 

By setting common rules and responsibilities, the AHL supports the functioning of the 
internal  market  for  live  animals  and  germinal  products  and  provides  a  basis  for 
coordinated action in both routine and crisis situations. 

Between the adoption of the AHL in 2016, its entry into force, and its application from 
21 April 2021, the Commission developed the secondary legislative framework necessary 
to operationalise the Regulation.  

Prior to the date of application, the Commission adopted 11 delegated acts supplementing 
non-essential elements of the AHL and 17 implementing acts laying down technical and 
procedural rules required for its uniform application. In 2023 and 2024, two additional 
delegated  acts  were  adopted  concerning  vaccination  frameworks  and  poultry 
compartments. Taken together, these acts establish detailed provisions on disease listing 
and  categorisation,  notification  and  reporting  obligations,  surveillance  requirements, 
movement  conditions,  registration  and  approval  procedures,  and  the  use  of  disease 
preventive and control tools. 

Minimum and time-bound notification and disease reporting obligations were defined, 
together with harmonised surveillance requirements. The framework specifies preventive 
tools, including biosecurity obligations applicable to operators and competent authorities, 
and sets out the legal conditions under which vaccination may be used for prevention and 
control  purposes.  It  also  provides  for  Union  antigen  and  vaccine  banks  for  certain 
category A diseases such as FMD, CSF, LSD, SPGP, PPR. 

In  the  area  of  movements,  identification  and  traceability,  species-specific  registration, 
identification  and  record-keeping  requirements  were  laid  down  in  delegated  acts. 
Harmonised movement conditions were established, including calibrated derogations and 
channelling arrangements linked to disease categories, zoning decisions and defined low-
risk situations. 

Operators and establishments are required to register or obtain approval in accordance 
with  common  criteria  and  procedures,  including  rules  governing  suspension  and 
withdrawal.  Member  States  are  obliged  to  maintain  and  make  available  transparent 
registers. 

Preparedness and response mechanisms were defined through harmonised principles of 
disease control including stamping-out and other control measures, vaccination strategies, 
post-outbreak  surveillance  and  contingency  planning.  Compared  to  the  previous 
framework, the requirement for prior Commission approval of each national contingency 
plan was removed. 

The  AHL  framework  also  establishes  structured  rules  for  regionalisation  during 
outbreaks. For entry into the Union from third countries, harmonised requirements were 
laid down in substantive legislation, including third-country listing, defined animal health 

22 

 
guarantees  and  model  certificates,  operating  within  the  framework  of  the  WTO  SPS 
Agreement and aligned with relevant international standards. 

This legislative and implementing framework constitutes the operational baseline against 
which  the  effectiveness,  efficiency  and  coherence  of  the  AHL  are  assessed  in  the 
subsequent chapter. 

3.1   Sectoral background 

The AHL operates within a sector of considerable economic scale. In 2025, the European 
Union had a significant livestock population: 132 million pigs, 72 million bovine animals, 
54 million sheep and 10 million goats, and around 1.7 billion poultry birds (7). 

There are approximately 4.1. million farms with livestock in the EU, representing 41% 
of all EU farms (2020 data) (8). In details, 21.6% of farms with livestock are classified as 
livestock specialists while 19.3% as mixed farming thus combining crops and livestock 
activity.  

The majority of farms are small, with 41% having less than 2 hectares and around 60% 
having fewer than 5 livestock units (LSU). It must be noted that a majority of the farms 
below 5 LSU are in mixed farming systems and notably in two Member States: Romania 
and Poland (9). 

EU aquaculture production amounted to approximately 1.1 million tonnes (live weight) 
in 2023, including finfish, molluscs and crustaceans, with a production value of around 
€4.8 billion. 

In addition, other animal populations, such as horses, farmed deer, rabbits and bees, also 
contribute to the agricultural economy and these sectors should be considered to provide 
a more complete picture of animal production. Out of 2 020 breeders surveyed11 in 2015 
from 12 Member States representing around 85% of the EU population of dogs and cats, 
87%  self-reported  they  were  hobby  breeders,  and  only  13%  self-reported  they  were 
professional breeders. However, categories, definitions and thresholds of breeders differ 
depending on national legislation 

The  pet  sector  represents  a  further  area  of  economic  activity  and  social  relevance, 
although harmonised EU-level statistics remain limited. The EU pet market for dogs and 
cats is supplied by a large but fragmented breeder population. In 2015, a survey of 2,020 
breeders across Member States covering around 85% of the EU pet population found that 
87% (≈1,750) were hobby breeders and 13% (≈260) professionals. One estimate suggests 
around 32,000 professional breeders in the EU10. 

Animals  used  for  scientific  purposes  account  for  comparatively  smaller  numbers.  Fur 
farming persists in a limited number of Member States and has declined over time, while 

7 

8 
9 
10  

Eurostat: Livestock populations (apro_mt_lscatl, apro_mt_lsgoat, apro_mt_lssheep, apro_mt_lspig, 
agr_r_animal). Farm structure (ef_lsk_poultry). 
Eurostat: Farm structure (ef_m_farmleg). 
Farm Sustainability Data Network (FSDN). 
COMMISSION  STAFF  WORKING  DOCUMENT  Summarising  evidence  supporting  the 
legislative  proposal  on 
traceability 
https://food.ec.europa.eu/document/download/caf8cd1d-967a-4e60-a0e5-19401be1c6b3_en. 

the  welfare  of  dogs 

their 

cats 

and 

and 

23 

 
 
remaining of economic relevance in certain regions. Comprehensive Union-wide data are 
not available for animals kept in sports, entertainment or non-commercial contexts. 

Taken  together,  these  figures  illustrate  the  scale,  diversity  and  economic  relevance  of 
sectors covered by the AHL. They also demonstrate the potential exposure of significant 
production systems, trade flows and rural livelihoods to animal disease risks. 

3.2   Legal evolution and transitional phase (2016–2021) 
Between the adoption of the AHL in 2016 and its application from 21 April 2021, the 
Commission  undertook  the  legislative  work  necessary  to  render  the  Regulation  fully 
operational.  This  process  involved  repealing  and  replacing  39  separate  legal  and 
consolidating previously fragmented provisions into a single coherent legal framework 
supported by supported by delegated and implementing legislation. 

To operationalise the AHL, the Commission prepared and adopted a series of delegated 
and implementing acts establishing directly applicable rules on all key elements and parts 
covered by the scope of the AHL. 

In 2020 the Commission’s reported on the exercise of its delegated powers11 confirmed 
that substantial legislative development took place between 2018 and 2020, culminating 
in  the  adoption  of  delegated  regulations  forming  the  core  of  the  secondary  legal 
framework (see for more details in Annex VI). By the date of application, the Commission 
had adopted 10 delegated acts supplementing non-essential elements of the AHL and 13 
implementing acts laying down detailed technical provisions (see Figure 2). These acts 
established the operational framework required for uniform application across Member 
States. A complete update list of all delegated and implementing acts is available at the 
Commission’s animal Health Law website12 

Figure 2: Key delegated and implementing acts accompanying the Animal Health 
Law 

11  
12  

EUR-Lex - 52021DC0057 - EN - EUR-Lex. 
Delegated and implementing acts - Food Safety - European Commission. 

24 

 
 
 
 
The  tertiary  legislation  gave  effect  to  the  structured  disease  listing  and  categorisation 
system  (categories  A–E),  establishing  a  single  Union  list  of  diseases  subject  to  Union 
action  and  specifying  the  associated  surveillance  and  control  measures.  It  further 
specified  preventive  obligations,  including  biosecurity  requirements,  surveillance 
responsibilities,  animal  health  visits  and  conditions  for  the  use  of  vaccination.  Union 
antigen  and  vaccine  banks  were  established  under  the  legal  framework  to  support 
emergency preparedness. 

The  AHL  and  its  implementing  acts  established  reinforced  notification  and  reporting 
obligations and provided the legal basis for the ADIS, the Union’s computerised system 
for  disease  notification  and  reporting.  Surveillance  requirements,  including  Union 
surveillance programmes where relevant, were defined in secondary legislation. 

Common  principles  for  disease  control  measures,  vaccination  strategies  and  post-
outbreak surveillance were laid down. Derogations for defined low-risk movements and 
provisions  for  zoning  and  channelling  during  outbreaks  were  specified  in  secondary 
legislation. Additional requirements were laid down for specific establishments and for 
transport operators. 

Animal health requirements for entry into the Union were consolidated and harmonised 
in delegated and implementing acts, including third-country listing, model certification 
requirements  and  procedures  for  managing  non-compliance.  These  rules  replaced 
previously dispersed provisions laid down in multiple legal acts and certificates. 

These  legislative  and  supporting  measures  constitute  the  implementation  framework 
against which the effectiveness, efficiency, coherence and EU added value of the AHL 
are assessed in the subsequent sections. 

3.3   Implementation by the European Commission (2021 - 2024) 

Between 2021  and 2024, the Commission  operationalised the  AHL  through continued 
regulatory  updates,  coordination  of  outbreak  response,  technical  support  to  Member 
States and the further development of information systems. 

During this period, the Commission adopted additional delegated and implementing acts 
where necessary to clarify provisions, address practical implementation issues identified 
by  Member  States  or  stakeholders,  and  respond 
to  evolving  epidemiological 
developments. In particular, many amendments to implementing acts were triggered by 
outbreaks of HPAI (113 amendments), ASF (88), SPGP (63), PPR (35), l LSD (25) and 
Newcastle  disease  (ND)  (11).  These  amendments  primarily  established  emergency 
measures,  particularly  regionalisation,  which  allows  disease  control  measures  to  be 
limited to affected areas while permitting certain activities and movements to continue in 
affected zones under defined conditions. The Commission also regularly updated import 
requirements  and  disease-related  restrictions,  in  particular  through  amendments  to 
Commission Implementing Regulation (EU) 2021/404, which lays down the lists of third 
countries or zones authorised for entry into the Union of animals and certain products of 
animal  origin.  Between  2021  and  2024,  139  implementing  regulations  amending 
Regulation (EU) 2021/404 were adopted, reflecting changes in the global animal health 
situation and the application of regionalisation principles. 

25 

 
In parallel, guidance documents, explanatory material and sector-specific communication 
tools were issued to  support uniform  understanding  and application of the framework. 
Clarifications on surveillance obligations, movement  rules, vaccination  conditions  and 
preparedness requirements were discussed in expert meetings, bilateral exchanges and in 
the PAFF Committee (Animal Health and Welfare and Controls and Import Conditions 
sections), particularly during the first years of application. 

Capacity-building  measures  were  implemented  through  the  Better  Training  for  Safer 
Food (BTSF) programme. Training activities covered surveillance, contingency planning, 
disease  control  measures,  movements  and  emergency  preparedness,  contributing  to  a 
common understanding of the new framework among competent authorities. In 2021, the 
Commission also conducted a communication campaign and made information material 
available in all official Union languages, including factsheets, posters and explanatory 
videos. These materials were distributed to Member States and made publicly available. 

The  Commission  further  developed  the  ADIS  as  the  central  EU  IT  platform  for 
notification  and  reporting  of  animal  diseases.  This  IT  system  supports  real-time 
information  exchange  between  Member  States  and  the  Commission  and  has  been 
progressively  aligned  with  international  reporting  obligations,  including  links  to  the 
World Animal Health Information System (WAHIS) of WOAH. 

In  outbreak  situations,  coordination  at  Union  level  frequently  began  at  an  early  stage, 
including preparatory exchanges prior to formal confirmation where appropriate. Rapid 
information exchange and alignment of measures took place through: 

•  meetings of the PAFF Committee (Animal Health and Welfare section); 
•  meetings of the EU Chief Veterinary Officers Working Party; and 
•  ad hoc expert-level technical discussions. 

These  mechanisms  facilitated  the  adoption  and  updating  of  implementing  acts 
establishing  protective  measures,  regionalisation  arrangements  in  affected  areas.  To 
support  situational  awareness  and  coordinated  communication,  the  Commission 
facilitated  regular  information  exchange  by  circulating  information  notes  to  Member 
States and, where relevant, to third countries, publishing outbreak data through ADIS, 
and ensuring coherence between EU notifications and international reporting obligations. 

The Commission provided technical and expert support to Member States through several 
mechanisms, including: 

•  deployment  of  the  EU  Veterinary  Emergency  Team  (EUVET)  for  on-the-ground 

technical assistance; 

•  activation of Union antigen and vaccine banks where vaccination was part of disease-

control strategies; 
requests for scientific advice from EFSA to inform control measures; and 

• 
•  support  from  EU  Reference  Laboratories  (EURLs),  including  validated  diagnostic 

methods, technical guidance and proficiency testing. 

Additional  surveillance  and  veterinary  programmes  in  high-risk  areas  were  supported 
through Union co-financing under the Single Market Programme. For example, in 2023 
Member  States  submitted  126  programmes  covering  11  diseases,  while  10  additional 
programmes  targeting  ASF,  l  LSD  and  rabies  were  implemented  in  five  neighbouring 

26 

 
third countries, with a total budget of around € 40.7 million. Funding focused in particular 
on  ASF,  HPAI,  Salmonella,  rabies,  and  TSE  surveillance,  supporting  targeted 
surveillance,  vaccination  campaigns  and  control  measures 
in  areas  at  higher 
epidemiological risk. A comparable level of support was maintained in subsequent years. 
For example, in 2024, 111 programmes were submitted by Member States and nine by 
third countries, corresponding to an eligible budget of around € 40 million. 

The EU provides also financial support to Member States during animal disease outbreaks 
through  the  veterinary  emergency  funding  mechanism  under  the  Single  Market 
Programme (SMP). Since 2023, the Union co-finances up to 30% of eligible direct costs, 
including compensation to animal keepers and certain eradication and control measures, 
with  the  remaining  share  borne  by  the  Member  State.  EU  financial  contributions  for 
animal  disease  eradication  and  emergency  measures  remained  significant  during  the 
evaluation  period,  amounting  to  €148.3  million  in  2025,  reflecting  expenditure  linked 
primarily to ASF and HPAI outbreaks. 

Figure  3  below  illustrates  Member  States’  total  emergency  expenditure  by  disease 
(updated to 31/12/2025), showing a clear concentration of the eligible for EU cofinancing 
costs in a number of outbreaks. Avian influenza accounts for by far the largest share of 
expenditure  (approximately  €396  million),  significantly  exceeding  all  other  diseases. 
Expenditure  related  to  ASF,  SPGP  and  other  listed  diseases  represents  comparatively 
smaller proportions of the total. 

Figure 3: total expenditure of Member States updated as of 31/12/2025. 

3.4   Implementation by Member States (2021–2024) 

Following the date of application of the AHL in April 2021, all Member States initiated 
processes  to  align  national  legislation,  administrative  arrangements  and  veterinary 
systems with the new framework. However, the pace and extent of alignment differed. 

Differences in administrative capacity, organisational structures and available resources 
influenced implementation trajectories. In Member States with federal or decentralised 
governance  structures,  alignment  required  coordination  across  multiple  regional  or 
institutional levels, which in some cases lengthened the adaptation process. 

27 

 
 
Legislative and administrative adjustments 

In  several  Member  States,  implementation  required  the  adoption  or  amendment  of 
national  legal  acts  in  order  to  complement  directly  applicable  Union  rules,  establish 
competent  authorities’  powers,  and  adapt  sanction  systems.  These  processes  often 
involved  parliamentary  procedures  and  inter-ministerial  coordination,  contributing  to 
variations in timing across Member States. 

Budgetary  constraints  were  reported  in  some  cases,  limiting  the  ability  to  recruit 
additional veterinary, legal or administrative staff specifically dedicated to AHL-related 
adjustments. 

Official controls and enforcement 

The Commission’s 2022 report on official controls1314 confirms that all Member States 
carried out official controls covering animal health obligations, including surveillance, 
movement controls, biosecurity and outbreak response. However, the depth, frequency 
and maturity of these controls varied between Member States, reflecting differences in 
resources, organisational models and stage of adaptation. 

While most Member States integrated AHL obligations and developed risk-based official 
control systems under the Official Controls Regulation (OCR), some continued to rely 
partly  on  control  approaches  developed  under  the  pre-AHL  framework.  Commission 
audits on animal health topics verify Member State compliance with relevant EU legal 
requirements. They therefore provide substantial  evidence on how the requirements of 
the AHL are being implemented in practice across Member States. Recurring findings 
from 2022-20224 include: 

incomplete or inconsistent application of biosecurity controls; 

• 
•  partial  non-compliance  with  surveillance  or  testing  obligations  in  certain 

sectors; 

•  delays in updating contingency plans and inspection procedures; 
•  uneven  application  of  risk-based  controls  across  regions  within  the  same 

Member State; 

•  sanction regimes not yet fully aligned with Article 268 AHL; and 
•  operational  capacity  limitations,  including  staffing  constraints  in  veterinary 

services. 

Sanctions and national flexibility 

Article 268 of the AHL requires Member States to establish effective, proportionate and 
dissuasive  sanctions.  All  Member  States  reviewed  their  national  penalty  systems 
following entry into application. However, progress in formally notifying national penalty 
provisions varied. According to the Commission’s 2022 state-of-play update presented to 

13  

Report from the Commission on the  overall operation of official controls carried out in Member 
States (2022) to ensure the application of food and feed law, rules on animal health and welfare, 
plant health and plant protection products.{SWD(2024) 208 final} 1_EN_ACT_part1_v3.docx. 

28 

 
 
 
the PAFF Committee in October 2023, only ten Member States had formally notified their 
national provisions by then. 

The AHL also provides flexibility for national adaptation. Article  269 allows Member 
States to maintain or adopt more specific or stricter national measures in certain areas. 
Similar  flexibility  is  provided  under  Articles  170,  171  and  226  for  disease-control 
measures concerning terrestrial and aquatic animals. Several Member States made use of 
this possibility, particularly in areas such as identification and registration, traceability, 
establishment  approval  and  biosecurity  requirements.  While  this  flexibility  allows 
adaptation  to  national  circumstances,  it  has  contributed  to  variation  in  the  detailed 
implementation of certain provisions. 

Court cases 

Regarding case law, there has been no ruling from the Court of Justice of the EU (CJEU) 
concerning  the  interpretation  of  the  AHL.  However,  the  EFTA  Case  E-8/24  Nordsjǿ 
Fjordbruk addresses the interpretation of Articles 10 and 269 of the AHL. The ruling on 
the case E-8/24 Nordsjǿ Fjordbruk, which was issued on 12 December 2024 by the Court 
of  Justice  of  the  European  Free  Trade  Association  (EFTA)  (hereinafter,  the  ‘EFTA 
Court’), represents the first decision of an international court on the AHL. While there is 
no doubt that this case bears relevance for the interpretation of the AHL, as transposed 
by Norway, it should nevertheless be noted that the rulings of the EFTA Court are directly 
binding  only  on  the  EFTA  countries  that  are  members  of  the  European  Economic 
Agreement (EEA Agreement), i.e. Iceland, Liechtenstein and Norway.   

External constraints and concurrent pressures 

Implementation  coincided  with  the  COVID-19  pandemic,  particularly  during  the  first 
year  of  application  of  the  AHL  Veterinary  services  and  competent  authorities  were 
required  to  prioritise  crisis  management  and  essential  controls,  which  in  some  cases 
delayed training activities and structural adjustments linked to the AHL. 

At  the  same  time,  major  animal  disease  events  during  the  evaluation  period  required 
substantial administrative and operational resources (see Section 3.4), further influencing 
the speed of implementation in certain Member States. 

Structural and cross-sectoral aspects 

Audits  and  follow-up  actions  carried  out  under  the  Official  control  framework  also 
highlighted  structural  issues  affecting  implementation  in  some  Member  States.  In 
particular,  audits  on  control  measures  for  Infection  with  Mycobacterium  tuberculosis 
complex  and  avian  influenza  highlighted  situation  where  effective  cross-sectoral 
collaboration  was  essential  but  not  always  sufficiently  developed.  These  included 
coordination  between  animal  health,  wildlife  and  environmental  authorities,  in 
surveillance and response activities.  

Key issues identified include: 

•  compensation and cost sharing schemes that may influence incentives for preventive 

measures; 

29 

 
•  challenges in wildlife health management where coordination between animal health 
and  environmental  authorities  was  limited  (e.g.  tuberculosis  in  wildlife  reservoirs)  
required; and 
the need for effective inter-sectoral  coordination in  areas  linked to  the One Health 
approach to support the surveillance and response. 

• 

Digital tools and system integration 

Implementation of the AHL was supported by EU-level digital systems. ADIS became 
the  central  IT  platform  for  harmonised  disease  notification  and  reporting,  and  its 
progressive  alignment  with  WOAH’s  WAHIS  system  reduced  duplication 
in 
international reporting. 

The Integrated Management System for Official Controls (IMSOC), including TRACES, 
was used for movement notification and certification. During 2021–2022, the transition 
from  TRACES  Classic  to  TRACES  NT  overlapped  with  the  early  years  of  AHL 
application, creating additional operational adjustments for competent authorities. 

Over the evaluation period, Member States progressively integrated AHL requirements 
into their national system and developed their official controls under the OCR. The AHL 
defines the substantive animal health obligations, while the OCR provides the verification 
and enforcement framework. 

3.5   Adaptation by operators 

Operators  across  the  animal  health  chain,  including  farmers,  veterinarians,  animal 
keepers,  transporters  and  other  businesses,  were  required  to  adjust  their  practices 
following the application of the AHL. 

Initial  adjustments  were  particularly  relevant  where  long-standing  national  practices 
differed from the new harmonised requirements, for example in relation to the registration 
of certain establishments (including smaller establishments) and the introduction of risk-
based animal health visits. In several sectors, the shift towards more structured preventive 
obligations required changes in internal procedures, documentation and interaction with 
competent authorities. 

The AHL clarified and harmonised responsibilities at Union level, including obligations 
relating to disease prevention, biosecurity, surveillance participation and notification of 
suspicions  of  disease  outbreaks.  Disease  reporting  became  governed  by  directly 
applicable Union rules rather than predominantly national provisions, providing common 
criteria for when and how suspicions must be notified. 

Operators  were  also  required  to  interact  more  systematically  with  veterinarians  in  the 
context  of  preventive  activities,  animal  health  visits  and  awareness  measures.  The 
introduction  of  animal  health  visits  represented  a  significant  operational  adjustment, 
particularly  in  the  absence  of  detailed  prescriptive  implementing  rules  at  Union  level, 
leaving room for national approaches to organisation and delivery. 

Movement  rules  and  certification  procedures  were  harmonised  through  directly 
applicable  Union  acts.  Operators  adapted  to  the  use  of  EU  digital  systems,  especially 
TRACES under the IMSOC framework, for the notification and certification of certain 
movements within the Union and for entry into the Union. The transition from TRACES 

30 

 
Classic  to  TRACES  NT  during  the  early  years  of  application  required  additional 
adjustments.  In  some  cases,  digital  systems  progressively  replaced  paper-based 
procedures. 

During the evaluation period, operators adapted their practices in a context marked by 
significant epidemiological challenges. At the same time, trade flows in live animals and 
animal  products  continued  to  evolve.  Available  COMEXT  data  indicate  that  intra-EU 
trade  volumes  recovered  following  the  disruptions  observed  during  the  COVID-19 
period, despite the occurrence of major animal disease outbreaks such as African swine 
fever, highly pathogenic avian influenza and bluetongue. 

Figure 4 – EU Trade of live animals and animal products (EUR) 

Source: External study 

3.6   Epidemiological context 
The evaluation period coincided with an unusually intense and complex epidemiological 
situation.  Between  2016  and  2023,  the  animal  health  situation  in  the  Union  was 
characterised  by  a  high  and  sustained  burden  of  major  transmissible  animal  diseases 
(TADs), placing continued pressure on animal health systems during the period in which 
the AHL was introduced and applied. 

Figure 5– Overview of total animal disease outbreaks per year and per country from 
2000 to 2024 

Source: External study. 

31 

 
 
 
African swine fever 

ASF continued to spread across several regions of the Union, affecting both domestic pigs 
and wild boar populations. The number of affected Member States increased from 10 in 
2019 to 14 by 2023, with first detections in Germany, Italy, Croatia and Sweden, and re-
emergence in the Czech Republic and Greece. 

ASF remained predominantly a disease of wild boar populations, with occasional spill-
over  into  the  kept  pig  sector.  Control  was  complicated  by  wildlife  reservoirs  and 
environmental persistence. During the period, several Member States regained disease-
free  status  in  certain  areas  (e.g.  Belgium  in  2020  and  Sweden  in  2024),  and  in  other 
affected Member States restrictions were progressively lifted in defined zones following 
improvements in the epidemiological situation. Since 2023, no additional Member States 
have reported new ASF incursions. 

Figure 6 – Evolution African swine fever outbreaks in the EU, 2021 – April 2024 

Sheep pox and goat pox 

After decades of absence in parts of western Europe, SPGP re-emerged. Spain reported 
separate outbreaks  in  2022–2023 in  the regions of  Andalusia and Castilla-La Mancha, 
which had been disease free since 1968. The authorities confirmed, 30 outbreaks, leading 
to  the culling  of over 52,000 small  ruminants.  The last outbreak was reported in  May 
2023, and Spain self-declared disease-free status to WOAH in November 2023. 

In 2023, Greece reported sporadic outbreaks affecting approximately 2,000  animals in 
Central Greece and the island of Lesvos, and Bulgaria reported a single incursion in a 
border region after ten years of absence. These events required application of emergency 
measures and significant field operations. 

Bluetongue  

BT continued to pose challenges due to its vector-borne nature and circulation of multiple 
serotypes.  Between  2021  and  2023,  serotypes  1,  3,  4,  8  and  16  were  reported  across 
several Member States. BTV-4 was the most widespread, with 146 outbreaks across eight 
countries  affecting  approximately  25,000  susceptible  animals.  BTV-8  affected  France, 
Spain  and  Belgium,  while  more  limited  outbreaks  of  BTV-1  and  BTV-16  occurred  in 
southern Member States. Vaccination strategies differed between Member States, ranging 

32 

 
 
from  compulsory  vaccination  to  voluntary  schemes  or  no  vaccination,  reflecting 
epidemiological conditions and national policy choices. 

Highly pathogenic avian influenza 

The most significant epidemiological pressure during the evaluation period came from 
HPAI. A major epidemic began in October 2021, driven mainly by H5N1. Between 2021 
and 2023, HPAI affected wild birds, poultry and captive birds in up to 26 Member States. 

The  2021–2022  season  was  the  largest  recorded  HPAI  epidemic  in  EU  poultry,  with 
approximately  2,400  outbreaks  and  nearly  50  million  poultry  affected.  France  was 
particularly impacted, with around 1,400 affected establishments, in particular in the duck 
and goose fattening sector. Recurrence of outbreaks in this sector led to the introduction 
of  preventive  vaccination  in  2023.  From  late  2022  onwards,  H5N1  was  increasingly 
detected in mammals, including wild carnivores and fur-farmed species, although such 
cases remained limited. Outbreaks in wild birds continued into 2023, with a new epidemic 
season beginning in autumn 2023 linked to migratory bird movements. 

Figure  7  –  Evolution  of  Highly  pathogenic  avian  influenza  outbreaks  in  the  EU, 
October 2020 – March 2026 

Foot-and-mouth disease 

Beyond the targeted scope of this evaluation, in early 2025, FMD re-emerged in the Union 
for  the  first  time  in  decades,  placing  significant  pressure  on  animal  health  systems. 
Germany was the first Member State affected, reporting a confirmed case in cattle after 
more  than  35  years  without  occurrence.  Subsequent  detections  were  reported  in 
neighbouring  Hungary  and  Slovakia,  requiring  close  regional  coordination  with 
successful eradication of the diseases and regaining of disease-free status under WOAH 
of both countries in the same year 

The outbreaks led to the application of harmonised emergency measures under the AHL, 
including stamping-out, movement restrictions and the establishment of protection and 
surveillance  zones.  Management  of  the  situation  required  large-scale  mobilisation  of 
veterinary  services  and  activation  of  contingency  plans,  with  repeated  adjustments  of 
restricted  areas  as  the  epidemiological  situation  evolved.  The  economic  impact  was 

33 

 
 
substantial,  reflecting  direct  and  indirect  costs  related  to  disease-control  measures, 
including  culling,  compensation,  eradication  activities,  surveillance  and  movement 
restrictions, as well as trade-related consequences. For example, due to FMD Slovakia 
and Hungary reported high direct losses in 2025, e.g. over €10 million in Slovakia and 
more than €4 million in Hungary. 

Infection with Brucella abortus, Brucella melitensis and Brucella suis 

The epidemiological situation for brucellosis remained heterogeneous across the Union. 
Most Member States, particularly in northern and central Europe, have achieved officially 
brucellosis-free status, reflecting gradual progress in eradication. However, eradication 
programmes continue in several southern and south-eastern regions. In particular, parts 
of  southern  Italy,  Greece  and  certain  Balkan  regions  continue  to  implement  control 
programmes targeting infections in cattle, sheep and goats, with the aim of progressively 
expanding disease-free areas. 

Figure 8 – Infection with Brucella abortus, Brucella melitensis and Brucella suis in 
bovine animal population, in the EU, 2022 – 2026 

Infection with Mycobacterium tuberculosis complex 

Bovine  tuberculosis  caused  by  the  Mycobacterium  tuberculosis  complex  continues  to 
persist  in  certain  parts  of  the  Union.  Most  Member  States  have  achieved  officially 
tuberculosis-free  status,  particularly  across  northern,  central  and  eastern  Europe. 
However, eradication programmes remain necessary in several regions, including Ireland, 
Spain,  Portugal  and  parts  of  southern  and  south-eastern  Europe,  where  the  disease 
continues in cattle populations. 

Figure 9 – Evolution of Mycobacterium tuberculosis complex status in the EU, 2022 
- 2026 

Rabies 

Rabies  remained  largely  under  control  within  the  Union  during  the  evaluation  period, 
with only sporadic detections and continued progress in maintaining disease-free status 

34 

 
 
 
across most Member States. Most Member States maintained rabies-free status, reflecting 
the  long-term  success  of  oral  vaccination  programmes  in  wildlife,  combined  with 
surveillance and monitoring activities. However, a limited number of Member States in 
Eastern Europe continued to implement eradication programmes, particularly in border 
regions with neighbouring endemic areas in third countries. 

Figure 10 – Evolution of rabies status in the EU, 2022–February 2026 

Taken  together,  these  developments  illustrate  the  dynamic  and  heterogeneous 
epidemiological environment in which the AHL began to be implemented. During this 
period, Member States were required to manage simultaneous outbreaks of emerging and 
long-term  eradication  programmes,  and  adapt 
re-emerging  diseases,  maintain 
surveillance and control strategies to evolving epidemiological risks. At the same time, 
both  the  Commission  and  Member  States  were  still  adapting  to  the  AHL  and  its 
supplementary legislation. Implementation also coincided with other structural pressures, 
including the migration from TRACES Classic to TRACES NT, the operational effects 
of the COVID-19 pandemic and evolving climatic conditions influencing vector-borne 
disease dynamics. These contextual factors formed part of the operational environment 
in which the AHL was applied during its initial years. 

4.  Evaluation findings  

The evaluation questions covering all evaluation criteria are presented in Annex III. 

4.1  To what extent was the intervention successful and why? 

4.1.1. Effectiveness 

The evaluation finds that the AHL has been largely effective in establishing a more 
harmonised,  risk-based  and  preventive  Union  framework  for  animal  health.  It 
replaced  a  fragmented  legal  landscape  with  a  single  framework  covering 
prevention, surveillance, preparedness, disease control, traceability, movements 
and coordinated response. 

The  AHL  has  particularly  strengthened 
legislative  coherence,  clarified 
responsibilities  for  competent  authorities,  veterinarians  and  operators,  and 
introduced  a  more  structured  system  for  disease  listing,  categorisation  and 
proportionate  measures.  It  has  also  reinforced  the  legal  basis  for  surveillance, 
early notification, traceability, regionalisation and the use of vaccination.  

Evidence from consultations, surveys, interviews and case studies indicates that 
these  changes  have  improved  preparedness,  coordination  and  the  capacity  for 
earlier  detection  and  more  targeted  responses.  EU  IT  tools  such  as  ADIS  and 

35 

 
 
TRACES, together with regionalisation, have supported disease management and 
helped maintain intra-Union trade during outbreaks. 

At the same time, effectiveness in practice remains uneven across Member States 
and  sectors.  Differences  in  legislative  alignment,  administrative  capacity, 
veterinary  workforce  availability,  digital  systems  and  enforcement  affect 
consistent  application,  while  some  provisions,  notably  animal  health  visits, 
contingency  planning  and  certain  biosecurity  obligations,  are  not  yet  fully 
implemented. 

Overall, the AHL has achieved its core objective of modernising the EU animal 
health  framework  and  strengthening  the  conditions  for  prevention  and 
coordinated  disease  control.  Its  full  effectiveness  will  depend  on  continued 
implementation,  practical  simplification  and  support  for  consistent  application 
across Member States. 

The general objective of the AHL is to ensure a high level of animal health within the 
Union,  supporting  sustainable  agricultural  and  aquaculture  production,  contributing  to 
public health protection and food security, and safeguarding the proper functioning of the 
internal market. The evidence indicates that this objective has been achieved to a large 
extent.  The  AHL  has  established  a  common  legal  architecture  for  prevention, 
surveillance, preparedness, disease control, traceability and animal movements, replacing 
a  fragmented  set  of  disease-  and  sector-specific  instruments  with  a  single  framework. 
Stakeholders widely recognise that this has shifted Union animal health policy towards a 
more preventive, risk-based and coordinated system. 

Survey results show generally positive, though mixed, perceptions of the achievement of 
the general objectives (see Figure 11). More than half of respondents consider that the 
AHL has contributed positively to disease prevention and control and to the functioning 
of  the  internal  market,  while  slightly  fewer  report  improvements  in  animal  health 
supporting  sustainable  production.  National  competent  authorities,  civil  society  and 
academia tend to express more positive views, while farmers and industry representatives 
are  more  cautious,  often  pointing  to  compliance  costs  and  practical  implementation 
challenges. 

36 

 
 
Figure  11  –To  what  extent  has  the  AHL  been  successful  in  achieving  its  general 
objectives? 

N = respectively 90, 88 and 87 
Source: external study 

At the same time, the full achievement of the general objective in practice is constrained 
by  uneven  national  implementation,  differences  in  administrative  capacity,  veterinary 
workforce shortages, variable digital readiness and the fact that many expected benefits 
are preventive and therefore not directly observable.  

Evidence  from  stakeholder  consultations15,  feedback  from  the  CfE,  and  country  case 
studies,  including  Austria,  Italy  and  Spain,  confirms  that  the  intervention  logic  of  the 
AHL is broadly coherent, relevant and aligned with stakeholder needs.16  

However,  effectiveness  in  practice  has  been  affected  by  the  pace  and  unevenness  of 
implementation  across  Member  States.  Although  the  AHL  provided  for  a  five-year 
transition period between its adoption in 2016 and its application in 2021, implementation 
was affected by delays in certain delegated acts and by constraints linked to the COVID-
19 crisis. 

The  Commission  supported  the  transition  through  temporary  and  practical  measures, 
including continued use of certain animal health certificates for entry into the Union until 
October  2021,  derogations  for  intra-Union  certificates,  flexible  compliance  and 
enforcement approaches, discussions in the PAFF committee, communication activities 
and  capacity-building  under  the  BTSF  programme.17  These  measures  helped  Member 
States  during  the  adjustment  phase,  but  also  show  that  achievement  of  the  AHL’s 
objectives depends not only on legislative design but also on implementation capacity. 

Survey  evidence  from  national  competent  authorities,  although  limited  in  coverage, 
supports this conclusion: six out of nine respondents18 reported that significant adaptation 
was  still  ongoing,  while  only  one  reported  full  completion  and  one  reported  that  only 
minimal adaptation was needed. Interviews and validation workshop discussions further 
indicate  that  several  Member  States  remain  in  the  process  of  consolidating  national 

15  
16  
17  
18  

External study, Annex V, p XCVI. 
External study p 56 , Annex V p XCVI. 
European Parliament (2020) Parliamentary question - E-004906/2020(ASW). Available here. 
External study, p 57. 

37 

 
 
 
 
 
 
 
 
 
 
legislation, with two reporting remaining legal gaps and six reporting ongoing legislative 
consolidation. 

Country examples illustrate both progress and remaining gaps. Austria has progressively 
repealed legacy legislation, culminating in the adoption of a new Animal Health Act in 
2024. Italy adopted a comprehensive package of legislative decrees in 2022, followed by 
corrective measures in  2024, although implementation  of certain  provisions, including 
Article 25 on animal health visits, remains incomplete. Spain updated its identification 
and  traceability  system  through  Royal  Decree  787/2023,  as  amended  in  2024,  while 
maintaining  flexibility  for regional authorities.  In Germany, progress  has been slower, 
partly  due  to  the  federal  legislative  structure  requiring  coordination  across  Länder.19  
Taken together, this indicates that uniform implementation of the AHL has not yet been 
fully  achieved,  limiting  the  extent  to  which  the  broader  objectives  can  already  be 
considered fully realised in practice. 

Achievement of the specific objectives: 

The first specific objective is to establish a single, simplified, transparent and coherent 
regulatory  framework  replacing  the  previously  fragmented  legislation.  The  evidence 
indicates  that  this  objective  has  been  largely  achieved  in  terms  of  legal  coherence, 
transparency and consolidation, but only partially in terms of simplification in practice.  

From  a  legislative  perspective,  the  AHL  has  created  a  single  Union  framework  by 
consolidating numerous legal acts into one Regulation, clarifying the overall structure of 
the regime and improving the allocation of responsibilities across the animal health chain. 
Survey evidence supports this conclusion:  13 out of 17 national  competent  authorities 
considered  that  the  AHL  had  improved  the  delineation  of  responsibilities  between 
competent authorities, veterinarians and operators, while 11 out of 17 reported a clearer 
allocation of roles. 

However,  simplification  has  not  yet  been  fully  realised  operationally.  Eight  out  of  17 
national competent authorities reported that the framework remains complex due to the 
coexistence of the AHL with legacy national legislation, the large number of delegated 
and  implementing  acts,  and  the  need  to  cross-reference  with  other  Union  instruments, 
notably  Regulation  (EU)  2017/625  on  official  controls.  Stakeholders,  including 
competent authorities, veterinarians and operators, also reported difficulties in identifying 
the applicable rules and called for clearer, more practical guidance. 

Implementation has also required significant administrative, financial and IT resources. 
Some  Member  States,  such  as  Austria,  Italy  and  Spain,  have  largely  modernised  their 
legal  frameworks  and  updated  key  systems,  as  described  above20.  Others  introduced 
targeted support measures to facilitate implementation. For example, Bulgaria established 
a  dedicated  working  group  involving  policymakers,  veterinary  authorities  and 
stakeholders  to  support  integration,  while  Hungary  launched  a  broad  communication 
campaign to promote understanding and compliance. Still, many MSs remain engaged in 
more fundamental restructuring of national rules and administrative practices. 

19  
20  

External study, p 52. 
External study, p 55. 

38 

 
 
Common challenges nevertheless persist across Member States, including the complexity 
of  the  multi-layered  legal  framework,  adaptation  of  IT  systems,  shortages  in  the 
veterinary workforce, and the need for more consistent enforcement. These differences 
affect  the  uniform  application  of  key  provisions  and,  consequently,  the  overall 
effectiveness of the AHL.  Continued guidance, training and practical support at Union 
level therefore remain important to support more consistent implementation. Overall, the 
objective  of  establishing  a  single  and  coherent  Union  framework  has  been  largely 
achieved,  while  simplification  and  ease  of  application  have  so  far  been  achieved  only 
partially. 

Disease listing, prioritisation and categorisation  

A  large  majority  of  national  competent  authorities  (13  out  of  17)  considered  that  the 
categorisation system has improved prioritisation and supported more proportionate and 
risk-based measures,  particularly  for transboundary animal  diseases. Stakeholders  also 
indicated  that  the  system  has  increased  transparency,  supported  more  harmonised 
decision-making  and  facilitated  resource  allocation  according  to  risk.  Scientific 
assessments  by  EFSA21  provide  the  basis  for  disease  categorisation.  Consultation 
evidence  further  indicates  that  competent  authorities  generally  consider  the  system  to 
have  improved  disease  management  and  early  detection  through  more  targeted 
surveillance and control22.  

However,  challenges  remain  in  practical  application.  Six  out  of  17  NCAs  reported 
difficulties  in  applying  categories  in  complex  or  rapidly  evolving  epidemiological 
situations,  while  some  stakeholders  highlighted  uncertainties  in  interpreting  certain 
categories,  particularly  in  borderline  cases.  Frequent  updates  through  delegated  and 
implementing acts, while necessary to reflect changing risks, have also been identified as 
a source of uncertainty and uneven implementation. 

Some stakeholders noted that these updates can be difficult to follow in practice, and that 
clearer,  more  structured  guidance  would  improve  predictability  and  more  consistent 
application of risk-based measures. Overall, the categorisation system provides a strong 
basis  for  proportionate,  science-based  intervention,  although  evolving  epidemiological 
developments and climate-related pressures continue to test its operational adaptability. 

In practice, beyond the categorisation system itself, authorities also apply additional risk-
based prioritisation criteria. Audit evidence from Member States such as Denmark and 
Hungary  shows  that  some  authorities  use  risk  factors  such  as  establishment  size, 
compliance  history  and  outbreak  records  to  prioritise  inspections  and  surveillance 
activities. 

Strengthening prevention and preparedness  

Consultation evidence indicates that the AHL has strengthened the preventive dimension 
of  the  Union  framework  through  clearer  obligations  on  surveillance,  early  detection, 
notification, reporting, biosecurity and contingency planning. A majority of NCAs (12 
out of 17) reported improvements in surveillance systems and early detection capacity. 

21  

22  

EFSA AHAW Panel 2017. Scientific opinion on an ad hoc method for the assessment on listing 
and categorisation of animal diseases within the framework of the Animal Health Law. EFSA 
Journal 2017; 15(7):4783, 42 pp. https://doi.org/10.2903/j.efsa.2017.4783. 
See Annex V - Synopsis report. 

39 

 
 
Veterinarians also indicated greater awareness and earlier notification of suspected cases. 
Preparedness  has  improved  through  more  systematic  use  of  contingency  plans  and 
simulation  exercises,  including  in  response  to  recent  outbreaks  of  HPAI  and  ASF. 
Mandatory notification deadlines and clearer reporting obligations have supported faster 
information exchange and more timely application of control measures. 

At  the  same  time,  implementation  of  these  tools  remains  uneven.  Mandatory  animal 
health  visits  under  Article  25  are  not  consistently  applied  across  Member  States. 
Stakeholders  reported  that  veterinary  workforce  shortages,  cost  considerations  and  the 
structural characteristics of extensive farming systems limit implementation, particularly 
in smaller or remote establishments. This is especially relevant for sectors such as small 
ruminants and backyard farming, where limited veterinary coverage may weaken early 
detection. 

Country evidence illustrates these differences, including more systematic monitoring in 
intensive  sectors  and  less  consistent  coverage  in  extensive  systems.  In  Ireland,  cattle 
farms  benefit  from  regular  tuberculosis  testing,  while  many  smaller  and  remote  sheep 
farms  do  not  receive  routine  visits;  a  voluntary  biosecurity  scheme  exists  but  is  not 
mandatory. In Romania, commercial pig farms are regularly monitored, whereas the large 
number of backyard farms makes consistent oversight more difficult. In the Netherlands, 
structured  veterinary  engagement  remains  stronger  in  intensive  sectors,  with  less 
consistent  coverage  in  more  extensive  sectors  such  as  sheep  and  hobby  farming. 
Stakeholders  also  pointed  to  the  financial  burden  for  small-scale  farmers  and  limited 
veterinary availability in rural areas. 

Preparedness tools also vary in quality and frequency. Audit findings and case studies, 
including  Denmark,  Sweden  and  Hungary23  show  that  regularly  updated  contingency 
plans and simulation exercises improve chains of command, communication flows and 
operational  readiness.  Conversely,  outdated  or  incomplete  plans  reduce  response 
efficiency.  Stakeholders  also  pointed  to  uneven  coordination  regarding  wildlife 
surveillance and interfaces with environmental authorities. 

The  AHL  has  also  strengthened  prevention  by  reinforcing  biosecurity  obligations, 
surveillance  and  movement  controls,  thereby  contributing  to  a  more  structured  and 
preventive  animal  health  regime.  While  these  measures  can  generate  financial  and 
administrative  costs  in  some  settings,  particularly  for  farmers  required  to  invest  in 
fencing,  controlled  access  points  or  hygiene  infrastructure,  these  costs  are  linked  to 
stronger preventive capacity and improved preparedness.  

Biosecurity  implementation  differs  significantly  across  sectors.  Evidence,  including 
findings from an FVE study,24 indicates higher levels of compliance in the pig and poultry 
sectors,  where  biosecurity  requirements  are  longer  established  and  enforcement  more 
systematic. By contrast, dairy, beef, sheep and goat sectors show lower and more uneven 
implementation, often linked to extensive production systems, lower margins and more 
limited enforcement capacity. Aquaculture stakeholders also reported unclear guidance, 
inconsistent  inspection  practices  and  called  for  more  species-specific  requirements  to 

23  
24  

External study, p 67. 
External study, p 82. 

40 

 
 
avoid  uneven  application  across  regions.  In  peripheral  or  mountainous  areas,  limited 
veterinary availability further constrains implementation. 

Traceability systems are widely regarded as a key strength, enabling effective monitoring 
of  animal  movements  and  supporting  disease  control.  However,  veterinarians  and 
operators  reported  additional  administrative  workload  linked  to  documentation  and 
reporting  obligations,  particularly  for  smaller  establishments  and  sectors  with  limited 
administrative  capacity.  The  scale  of  benefits  also  varies  across  Member  States.  In 
countries  with  well-developed  systems,  the  AHL  has  mainly  consolidated  existing 
practices, whereas Member States with less developed systems reported more substantial 
gains in surveillance and preparedness, albeit with higher adaptation costs. 

The  AHL  has  also  enabled  more  flexible  use  of  vaccination,  where  justified  by  the 
epidemiological  situation.  Several  Member  States  have  implemented  vaccination 
strategies  against  listed  diseases,  including  preventive  vaccination  against  HPAI  in 
France  and  bluetongue  vaccination  in  Spain,  France,  the  Netherlands  and  Bulgaria. 
Stakeholders noted that the AHL has provided a clearer EU legal basis for such measures. 

The  experience  with  preventive  vaccination  against  HPAI  in  France  is  particularly 
illustrative, as shown in Figure 12. Following the introduction of preventive vaccination 
in the poultry sector, the number of outbreaks declined markedly. Available data indicate 
an approximately 99% reduction between 2021–2022 (1,377 outbreaks) and 2023–2024 
(10 outbreaks) after vaccination was introduced. The subsequent increase in 2025–2026 
(118  outbreaks)  nevertheless  shows  that  vaccination  can  substantially  reduce,  but  not 
eliminate, outbreak risk and must be combined with other measures such as biosecurity 
and movement controls. 

Beyond the direct  reduction  in  outbreaks, preventive vaccination also  generated wider 
economic  and  sectoral  benefits.  Previous  HPAI  crises  had  significantly  affected  the 
French poultry sector, including the foie gras industry, with impacts on production and 
sales. Outbreaks also triggered trade restrictions from key partners such as China, Japan 
and  the  United  States,  affecting  the  wider  poultry  value  chain  from  hatcheries  to 
processors,  including  smaller  producers.  Repeated  culling  and  prolonged  crisis 
management  also  placed  sustained  pressure  on  farmers  and  veterinary  services.  By 
reducing  the  frequency  and  scale  of  outbreaks,  vaccination  helped  limit  these  broader 
economic and operational disruptions. 

Stakeholders  acknowledged  that  the  AHL  has  provided  a  clearer  EU  legal  basis  for 
emergency vaccination and has supported the implementation of vaccination strategies in 
response to evolving disease risks. At the same time, some stakeholders noted that further 
adaptation  may  be  needed  in  specific  situations,  for  example  where  restrictions  on 
vaccination  in  disease-free  areas  do  not  fully  reflect  local  epidemiological  realities  or 
changing climate-related conditions. These observations point less to shortcomings in the 
framework itself than to the need for refinement as implementation experience grows. 

41 

 
Figure 12 – Results of poultry vaccination against HPAI in France 

Source: DG SANTE  

Taken together, these elements show that the objective of strengthening prevention and 
preparedness  has  been  achieved  in  terms  of  framework  design  and  direction,  but  only 
partially and unevenly in practice across sectors and territories. 

Clarify and rebalance the roles and responsibilities 

By replacing previously fragmented legislation with a single harmonised framework, the 
AHL has provided a clearer allocation of obligations and reduced uncertainty regarding 
responsibilities for prevention, notification, surveillance, control and recovery measures. 
The principle of shared responsibility is explicitly embedded in the framework: operators 
are responsible for biosecurity, early detection, notification and own surveillance under 
Articles  24  and  25;  veterinarians  play  a  role  in  surveillance  and  animal  health  under 
Article 25; and competent authorities are responsible for surveillance enforcement under 
Article 26. 

Interviewed  NCAs  reported  that  this  clearer  distribution  of  tasks  has  facilitated  more 
structured  coordination  during  outbreaks,  reduced  overlaps  in  control  activities  and 
improved compliance awareness, particularly among veterinarians and larger commercial 
operators.  Survey  evidence  also  supports  this  conclusion:  81%  of  respondents  (N=69) 
considered  that  the  AHL  has  improved  the  delineation  of  responsibilities  between 
competent authorities, veterinarians and operators, while 11 out of 17 NCAs reported a 
clearer allocation of roles. 

Several  NCAs noted during  the validation workshop that greater transparency in  rules 
and procedures has supported more open decision-making and helped build trust among 
stakeholders. By clarifying responsibilities and introducing more structured governance 
arrangements,  the  AHL  has  also  strengthened  channels  for  information  exchange  and 
engagement,  including  with  farmers  and  other  operators.  NCAs  are  generally  well 
engaged  at  Union  level  through  regular  exchanges,  including  meetings  of  the  PAFF 
committee. 

Several  NCAs noted during  the validation workshop that greater transparency in  rules 
and procedures has supported more open decision-making and helped build trust among 
stakeholders. By clarifying responsibilities and introducing more structured governance 

42 

 
arrangements,  the  AHL  has  also  strengthened  channels  for  information  exchange  and 
engagement,  including  with  farmers  and  other  operators.  NCAs  are  generally  well 
engaged  at  Union  level  through  regular  exchanges,  including  meetings  of  the  PAFF 
committee. 

While  the  practical  translation  of  legal  provisions  into  guidance  and  day-to-day 
implementation  still  varies  across  Member  States,  the  overall  direction  of  change  is 
positive. The evidence therefore indicates that the AHL has largely achieved the objective 
of clarifying and rebalancing responsibilities across the animal health chain. 

Proportionate and science-based disease control measures 

The  AHL  has  strengthened  the  Union’s  capacity  to  apply  targeted  disease-control 
measures while limiting unnecessary disruption to movements and trade. Strengthened 
traceability rules, regionalisation, restricted zones and proportionate movement controls 
enable  disease  containment  without  resorting  systematically  to  blanket  national  bans. 
Evidence from interviews  and case studies  confirms  the practical  value of these tools, 
including during SPGP outbreaks in Spain (Box 1) and in the continued management of 
ASF  (Box  2).  Although  implementation  may  require  case-specific  flexibility,  these 
mechanisms are operational and broadly effective. 

Box 1 – Sheep Pox and Goat Pox in Spain in 2022 

Following outbreaks of Sheep Pox and Goat Pox (SGP) in Spain in 2022, progressively 
stricter  measures  were  introduced  after  restricted  zones  were  established.  From 
February 2023, movement restrictions applied. In Castilla-La Mancha, all movements 
were  banned  except  for  immediate  slaughter,  while  movements  from  fattening 
establishments  were  allowed  only  to  slaughterhouses  following  prior  clinical 
inspection. From April 2023, movements from restricted zones to free areas required 
clinical  inspection  at  least  24  hours  before  departure,  with  transport  in  sealed  and 
disinfected vehicles. In June 2023, Spain notified the Commission that certain flocks 
previously moved for transhumance were now located in newly designated restricted 
zones  and  needed  to  return  to  their  place  of  origin.  The  Commission  therefore 
authorised a one-off derogation under a specific sanitary protocol, limited to the flocks 
concerned and without changing existing EU zoning or control measures.25 

Box 2 – ASF and regionalisation 

The  EU  approach  to  managing  ASF  has  been  progressively  developed  through 
Commission Implementing Regulation (EU) 2021/605 and its successor, Implementing 
Regulation (EU) 2023/594. These acts establish a structured regionalisation framework 
based on Restricted Zones I, II and III, reflecting the presence and spread of ASF and 
allowing  measures  to  be  calibrated  according  to  risk.  The  framework  is  updated 
regularly  to  reflect  the  evolving  epidemiological  situation,  including  the  continued 
persistence of ASF in wild boar populations. In 2024, several Member States, including 
Italy, Greece and Poland, saw adjustments to restricted zones. Some regions achieved 
reductions in restrictions following effective control measures, while certain areas in 
Czechia and Germany were delisted or downgraded after prolonged periods without 
new cases. This dynamic adjustment of restricted zones helps ensure proportionate and 

25  

External study, p.70. 

43 

 
 
risk-based  containment  measures  while  avoiding  unnecessary  disruption  beyond 
affected areas.26 

As shown in these examples, the framework is operational and effective, although it may 
require case-specific flexibility, and well aligned with relevant international standards, 
including  those  of  WOAH.  It  supports  science-based  intervention  through  structured 
procedures for listing diseases, surveillance and recognition of disease-free status. 

Measurable progress in disease control can be observed through control-related outputs, 
although  these  indicators  should  be  interpreted  with  caution.  Since  the  AHL  became 
applicable in 2021, successive updates to Implementing Regulation (EU) 2021/620 show 
an  expansion  of  recognised  disease-free  status  for  several  animal  diseases  across  the 
Union.27 

Several Member States have achieved or expanded disease-free status for bovine viral 
diarrhoea,  with  Austria,  Denmark,  Finland  and  Sweden  recognised  as  disease-free  for 
their  whole  territory,  together  with  several  German  Länder.  Progress  has  also  been 
recorded for viral haemorrhagic septicaemia, with six Member States currently listed as 
disease-free compared with five at the time of the initial adoption of the Regulation, and 
for infectious haematopoietic necrosis, for which five Member States are currently listed 
as disease-free28. Disease-free recognition has also expanded for certain other diseases, 
including  brucellosis  and  rabies.  Member  States  have  also  continued  to  implement 
eradication  programmes  under  the  AHL  framework,  including  programmes  targeting 
enzootic bovine leukosis in Croatia and bovine viral diarrhoea in Ireland. 

At the same time, the broader epidemiological context must be considered. Since 2021, 
the  Union  has  experienced  significant  outbreaks  of  ASF,  HPAI  and  BTV.  Disease 
dynamics  are  strongly  influenced  by  external  factors  such  as  climate  change,  wildlife 
reservoirs and trade patterns, making direct attribution to the AHL difficult. Within this 
context, the AHL contributes by providing a harmonised legal framework and common 
procedures that support more coordinated prevention and control efforts across Member 
States. Many of its benefits are also preventive in nature, including outbreaks avoided or 
mitigated, and are therefore not directly observable without counterfactual modelling. 

Overall, the evidence indicates that the AHL has materially strengthened the basis for 
proportionate  and  science-based  disease  control  across  the  Union,  while  measurable 
outcomes remain influenced by wider epidemiological developments. 

Improve flexibility and adaptability to emerging risks  

Compared  with  the  pre-AHL  framework,  the  AHL  enables  technical  measures  to  be 
updated more readily through delegated and implementing acts. This has strengthened the 
Union’s  ability  to  respond  to  new  scientific  evidence  and  changing  disease  situations. 

26  
27  

28  

External study, p.71. 
Commission Implementing Regulation (EU) 2021/620 of 15 April 2021 laying down rules for the 
application of Regulation (EU) 2016/429 of the European Parliament and of the Council as regards 
the approval of the disease-free and non-vaccination status of certain Member States or zones or 
compartments thereof as regards certain listed diseases and the approval of eradication programmes 
for those listed diseases, http://data.europa.eu/eli/reg_impl/2021/620/oj. 
External study,p.68. 

44 

 
 
Frequent  amendments,  targeted  derogations  and  emergency  measures  indicate  that  the 
framework can adapt when circumstances require it, although some stakeholders noted 
that updates can be difficult to track in practice. 

Recent developments illustrate this need. Persistent challenges linked to HPAI and ASF 
have  required  both  immediate  containment  measures  and  longer-term  management 
responses. Vector-borne diseases such as BTV have also highlighted the need to adjust 
categorisation,  vaccination  approaches  and  movement  conditions  as  risks  evolve. 
Stakeholders  further  pointed  to  the  importance  of  timely  coordination  on  vaccination, 
including regulatory pathways, procurement and stockpiling. 

The evaluation also identified positive examples of vaccination under the AHL, showing 
that  the  framework  supports  a  more  flexible  and  preventive  approach  where  justified. 
Some  stakeholders  nevertheless  considered  that  further  adaptation  may  be  needed  in 
specific  situations,  particularly  where  existing  restrictions  do  not  fully  reflect  local 
epidemiological realities or climate-related developments. 

Digital tools also contribute to adaptability by supporting coordination, traceability and 
disease management. However, performance remains uneven across Member States, and 
further  progress  in  interoperability,  practical  guidance  and  predictability  of  system 
updates would strengthen their contribution. 

Overall, the evidence indicates that the AHL has broadly delivered on its flexibility and 
adaptability  objectives,  while  continued 
further  strengthen 
responsiveness to future risks. 

refinement  would 

Enhance  coherence  with  related  Union  policies,  including  animal  welfare,  food 
safety and public health. 

The  AHL  operates  alongside  the  Official  Controls  Regulation,  food  safety  legislation, 
public health legislation and animal welfare rules. Its provisions on surveillance, disease 
notification, traceability and movement controls contribute to a more integrated approach 
to  risk  management  across  the  animal  health  chain.  These  mechanisms  facilitate 
information exchange and support more coordinated responses, particularly in relation to 
zoonotic diseases and cross-border health threats. 

Stakeholder feedback and consultation evidence indicate that this has strengthened links 
between animal health and public health systems, notably through improved data sharing 
and earlier detection of risks. Union IT systems such as ADIS, in combination with other 
EU  tools,  have  supported  more  structured  communication,  transparency  and  timely 
decision-making, contributing to earlier detection of risk. 

At the same time, achievement of this objective remains uneven in practice. Coordination 
across  policy  areas  depends  not  only  on  the  AHL  itself,  but  also  on  national 
implementation  and  interaction  with  other  legislative  frameworks.  Stakeholders, 
particularly  from  the  public  health  and  research  sectors,  noted  that  while  the  AHL 
provides a solid basis for cooperation, its practical contribution to a broader One Health 
approach remains partial. 

Links with certain policy areas, notably animal welfare and environmental policy, also 
remain  less  developed  operationally.  Stakeholders  reported  that  coordination  may  be 

45 

 
limited in specific situations, for example during outbreaks requiring restrictive measures 
or in areas involving wildlife and environmental domain. 

Overall, the AHL has provided a strong legal and structural basis for greater coherence 
with  related  Union  policies,  particularly  in  relation  to  public  health  as  regards 
surveillance, data exchange and coordinated response. Full realisation of this objective 
will  depend  on  continued  efforts  to  strengthen  practical  coordination  across  animal, 
human and environmental health systems in line with the One Health approach. 

Reduce  the  socio-economic  impact  of  animal  diseases  and  minimise  trade 
disruptions  

Harmonised rules on animal movements have contributed to greater safety, predictability 
and transparency in intra-Union exchanges. A majority of NCAs (10 out of 17), together 
with  industry  stakeholders,  reported  that  common  requirements  and  certification 
procedures  have  strengthened  trust  between  Member  States.  Instruments  such  as 
regionalisation  have  also  enabled  targeted  restrictions  during  outbreaks  while  helping 
maintain trade flows. 

Trade  data  and  stakeholder  feedback  indicate  that  the  internal  market  has  remained 
resilient. Intra-Union trade recovered strongly after 2021 despite outbreaks of ASF, HPAI 
and BTV, suggesting that the AHL framework has supported continuity of trade. Survey 
results  (N=87)  show  an  overall  positive,  though  not  unanimous,  assessment:  51 
respondents considered that the AHL had largely or moderately improved the functioning 
of the internal market, while 25 considered that improvements were limited and 9 that no 
improvement had been achieved. Interview evidence from 13 Member States similarly 
indicates that NCAs generally view the harmonised framework and clearer governance 
tools as having improved consistency of application. Supporting evidence also includes 
implementing acts establishing restricted zones, case studies such as Spain and Denmark, 
and COMEXT trade data showing strong recovery of intra-EU trade after 2021 despite 
outbreaks  of  African  swine  fever,  highly  pathogenic  avian  influenza  and  bluetongue. 
Please see Figures 4 and 13 

Figure 13 – Volume Index of EU movements and exports of live animals 

Source: External study 

While TRACES is generally recognised as a useful tool for managing cross-border animal 
movements, some users reported operational limitations, including unannounced system 

46 

 
  
updates affecting accessibility and delays in issuing certificates. These difficulties have 
at  times  increased  administrative  complexity  and  disrupted  planned  movements, 
particularly during the initial implementation phase. Stakeholders also called for further 
digitalisation  and  better  integration  of  identification,  health  and  certification  data. 
However,  the  efficiency  of  certification  systems  depends  largely  on  national  digital 
infrastructure and implementation choices, which go beyond the scope of the AHL itself. 

At the same time, meat and livestock stakeholders reported market disturbances during 
ASF  outbreaks,  particularly  in  Germany,  where  buyers  or  trading  partners  refused 
products  from  restricted  regions  despite  EU  regionalisation  rules  allowing  trade  from 
unaffected  zones.  This  suggests  that  the  functioning  of  the  internal  market  has  been 
supported  to  a  moderate  to  large  extent,  although  not  uniformly  across  sectors  or 
epidemiological situations. More broadly, the objective of reducing the socio-economic 
impact  of animal  diseases has been achieved only  to  a moderate  extent,  as substantial 
costs and burdens remain, particularly for smaller operators and during outbreaks. 

Limitations 

The findings on the achievement of the general and specific objectives of the AHL should 
be interpreted in light of three structural constraints. These do not reflect shortcomings of 
the  AHL  framework  itself  but  rather  affect  the  extent  to  which  its  impacts  can  be 
measured and compared across the Union. 

First,  implementation  remains  uneven  across  the  Union.  Legislative  alignment  is  still 
ongoing  in  several  Member  States,  while  provisions  such  as  animal  health  visits, 
contingency planning and simulation exercises are not yet applied consistently. As the 
AHL  is  implemented  through  national  administrative,  veterinary  and  IT  systems, 
differences in capacity and enforcement affect outcomes and limit comparability. 

Second, many benefits of the AHL are preventive and therefore not directly observable. 
The framework is designed to reduce the likelihood and scale of outbreaks, but avoided 
events  cannot  be  measured  directly.  Disease  trends  and  disease-free  status  reflect  a 
combination  of  AHL  measures,  pre-existing  national  programmes  and  wider 
require  dedicated 
epidemiological  developments.  Robust 
counterfactual modelling beyond the scope of this evaluation. 

attribution  would 

Third, animal disease dynamics are strongly influenced by external factors beyond the 
legislation itself, including climate change, wildlife reservoirs, vector spread, production 
structures and trade flows. Recent outbreaks of ASF, HPAI and BTV, but not exclusively, 
illustrate that deteriorating epidemiological trends cannot automatically be interpreted as 
regulatory failure. 

These constraints do not call into question the value of the AHL itself but do indicate that 
structural improvements and implementation progress can be assessed more robustly than 
direct impacts on disease incidence overall. 

Overall assessment of achievements 

Overall, the impact of the AHL on Member States is clearly positive, although the scale 
of visible change varies by starting conditions. In Member States with mature systems, 
the AHL has mainly  consolidated and standardised existing  practices.  In  others, it has 

47 

 
driven  more  substantial  legislative  modernisation,  clearer  governance  and  stronger 
alignment  with  science-based  standards.  Across  the  Union,  it  has  strengthened 
harmonisation, legal coherence and the common operational basis for coordinated disease 
management. Continued intra-EU trade during repeated outbreaks also indicates greater 
systemic resilience. 

Unexpected  effects  identified  during  implementation  appear  mainly  linked  to  timing, 
uneven  national  alignment  and  resource  constraints  rather  than  weaknesses  in  the 
framework  itself.  Stakeholders  nevertheless  highlighted  the  need  for  clearer  guidance, 
more consistent application and fairer cost-sharing arrangements. 

This evaluation hence concludes that the AHL has largely achieved its core objective of 
establishing  a  coherent,  modernised  and  risk-based  EU  animal  health  framework. 
Objectives  relating  to  legislative  coherence,  clearer  responsibilities  and  disease 
categorisation  have  largely  been  achieved.  Objectives  relating  to  surveillance, 
preparedness,  traceability  and  internal  market  functioning  have  been  achieved  to  a 
moderate to large extent. Objectives relating to simplification, uniform implementation 
and measurable animal health outcomes have so far been achieved only partially or to a 
moderate extent. Further progress now depends primarily on continued implementation, 
practical refinement and more consistent application across Member States. 

4.1.2. Efficiency 

The  AHL  has  generated  uneven  and  partly  quantifiable  costs  and  benefits  for 
operators, veterinarians, and NCAs. While short-term compliance costs, such as 
legal adaptation, administrative restructuring, training, surveillance expansion, 
and  biosecurity  investments,  are  immediate  and  visible,  long-term  benefits  like 
improved  disease  prioritisation,  clearer  responsibilities,  stronger  coordination, 
and better crisis preparedness remain difficult to quantify comparably across the 
EU. 

A  key  limitation  of  the  assessment  is  the  AHL’s  recent  implementation  (since 
2021),  with  incomplete  national  alignment  and  underused  flexibility  in  some 
Member States. As a result, robust cost-benefit quantification is not yet possible, 
and findings rely on stakeholder perceptions, case studies, and national examples. 

The  short-term  efficiency  impact  is  mixed,  with  high  administrative  burdens, 
particularly where national systems were unprepared. However, the medium-to-
long-term outlook is broadly positive, with potential for greater efficiency through 
targeted  surveillance,  optimised  resource  allocation,  and  stronger  prevention 
provided implementation becomes more uniform, administrative fragmentation 
reduces, and digital/regulatory tools are better utilised. 

The evaluation of the AHL’s efficiency considers whether the costs incurred by Member 
States, stakeholders, and the European Commission, since 2021 have been proportionate 
to the benefits achieved. 

Current evidence indicates that the AHL has generated both additional costs and benefits 
for businesses, veterinarians and NCAs, though these remain unevenly distributed and 

48 

 
 
only partially quantifiable. The available data is largely perception-based, as the AHL has 
only been in force since 2021 and harmonised quantitative metrics are still limited. Costs, 
such  as  those  related  to  legal  adaptation,  administrative  reorganisation,  training, 
reporting, surveillance expansion, and biosecurity compliance, are immediate and highly 
visible, particularly  for farmers  and  NCAs.  In  contrast,  benefits  like improved disease 
prioritisation,  clearer  allocation  of  responsibilities,  stronger  coordination,  better 
traceability, and potentially fewer or less severe outbreaks are preventive and structural 
in nature, making them harder to quantify in a robust and comparable manner across the 
EU. While stakeholders already recognise these benefits, their long-term and preventive 
nature complicates efforts to measure them effectively. 

Consultation  evidence  from  the  CfE  (2024,  215  respondents)  shows  that  stakeholders 
perceive animal  movement  (86/215) and general  implementation  costs (69/215) as the 
most  significant  cost  drivers,  while  traceability  (4/215),  disease  control  (4/215),  and 
enforcement (5/215) are less frequently cited. Hobbyists (167/215) report the highest cost 
burdens,  whereas  farmers  (6/215),  NCAs  (2/215),  other  operators  (3/215),  and 
veterinarians (1/215) are less affected, indicating that cost pressures are concentrated in 
specific stakeholder groups. However, these results should be interpreted with  caution 
due to overrepresentation of certain stakeholders (notably hobbyist) and the absence of 
bias correction29. 

Survey data (Figure 14) further reveals that farmers face increased costs under the AHL, 
particularly in training (22/35 respondents), veterinary visits (19/35), biosecurity (17/35), 
and  record-keeping  (17/35).  These  costs  vary  by  farm  size,  animal  type,  and  national 
farms  and  aquaculture  operators  bearing  a 
implementation,  with 
disproportionately  higher  burden.  However,  these  findings  reflect  perceptions  from  a 
limited  sample  and  should  be  interpreted  with  caution.  They  do  not  allow  firm 
conclusions on the magnitude or distribution of the cost across the stakeholder group. 

smaller 

Figure 14: Survey replies to the question ‘In which of the following area(s) did you 
see a change in costs since the adoption of the AHL?’, by livestock and aquaculture 
farmers and industry representatives.  

Source:  External study.  

29  

External study, p 99. 

49 

 
  
 
The  stakeholder  group  most  frequently  reports  increased  costs  for  professional 
development,  particularly  training  (22/35  respondents).  A  notable  example  is  Italy’s 
mandatory  training  programme,  established  under  the  Ministry  of  Health  Decree  of  6 
September  202330 ,which  requires  livestock  and  aquaculture  farmers,  as  well  as 
transporters, to  complete 18 hours of training every three years on legal  requirements, 
major diseases, biosecurity, and related topics. The decree permits a 30% reduction in 
training duration based on the number of animals per establishment. 

Cost estimates (Table 1, 2020 data) indicate that training fees range from €140 to €200 
per farmer, varying by provider and livestock species31. Bovine farmers bear the highest 
total  costs,  given  their  larger  representation  among  Italian  livestock  farmers,  while 
apiculture and swine sectors face the lowest  estimated costs. The total  annual  cost  for 
training across all livestock species in Italy is approximately €47 million. Costs in other 
Member States may vary due to differences in training content, delivery methods, and 
duration. 

Table 1 – Cost estimation for mandatory training for livestock farmers in Italy  

Species  

Average 
training fee 
(EUR)(47)  

Periodi
city  

Duratio
n  

Hourly 
earning
s of 
Italian 
farmers 
(EUR)(4
8)  

N. of 
farmers 
affected in 
Italy (100% 
modality)(49)  

N. of 
farmers 
affected in 
Italy (30% 
reduction)  

Total cost 
(EUR)  

Total cost 
(EUR)/ year  

Apiculture   180  

Bovines  

173.3  

Ovine  and 
caprine  

140  

Poultry  

180  

18 
hours (1
00% 
modalit
y)  

20.4  

Once 
every  3 
years  

12,6 
hours (3
0% 
reductio
n)  

22610  

-  

7610526   2536842  

22810  

73370  

43906057

14635352  

50010  

37170  

40123049

13374350  

13980  

43110  

26490650

8830217  

Swine  

180  

15760  

22390  

18409198

6136399  

Total  

47100382  

Source: External study 

Respondents report increased costs in several key areas under the AHL: 

Biosecurity  measures  (e.g.,  fencing,  disinfection,  equipment)  require  additional 
investment or staff, with costs varying by national legislation and sector. For poultry and 
pig  farmers  previously  lacking  biosecurity  measures  beyond  standard  practices, 
compliance costs average €10,000 per farm for items like protective clothing, cleaning 

30  
31  

External study, p.100. 
External study, Annex 3, p70. 

50 

 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
equipment,  and  infrastructure  (fences,  window  coverings)32.  Cost  variations  reflect 
differing national and sectoral requirements. 

Veterinary  health  visits  (Article  25)  have  increased  costs  for  19/35  respondents, 
particularly  in  dairy,  beef,  and  sheep  sectors.  Small-scale  farmers  and  those  without 
private quality assurance (QA) systems face greater burdens. Where QA schemes already 
mandate regular visits  (e.g., Italian/Dutch poultry and pig  sectors), no additional costs 
arise. Average annual costs range from €150–350 per farm, influenced by visit frequency, 
combined purposes, and farm remoteness. 

Outbreak-related restrictions (e.g., for ASF, HPAI) incur compliance costs as part of 
disease-control  measures.  While  these  costs  are  inherent  to  effective  prevention 
frameworks,  small-scale  operators  struggle  with  absorption,  particularly  where 
compensation  is  perceived  as  insufficient  or  delayed.  This  highlights  implementation 
challenges rather than flaws in the AHL’s logic. 

Record-keeping  costs  have  risen  for  over  50%  of  respondents  (17/35),  especially  for 
newly covered operators (e.g., hobby poultry farms) where exemptions are not applied by 
the national authorities. In Italy, costs stem from stricter interpretations of AHL Article 
4(27)  (establishment  definitions)  and  TracesNT  improvements33.  In  the  Netherlands, 
initial registration and health plan development require 1.5 hours (€36.3 per farmer), with 
annual  record-keeping  demanding  8–12  hours  (10  hours  for  average-sized  farms,  198 
LSU/holding)34. Total annual record-keeping costs for Dutch farmers are estimated at €7 
million,  representing 0.06% of the Dutch livestock industry production  value (around 
EUR 11 billion) (Table 2). 

Table 2 – Cost estimation for record keeping for farmers in the Netherlands  

Type of activity  

Time 
spent 
(hours)  

Hourly 
earnings of 
Dutch 
farmers 
(EUR)54  

Farmers affected 
in the 
Netherlands  

Total cost (EUR)  

for 

Application 
and 
development  of  animal  health  and 
treatment plans (one-off)  

registration 

1.5  

Record 
for the average farm size  

keeping 

(yearly) 

10  

Record  keeping  (yearly)  for  below-
average farm size  

8  

Record  keeping  (yearly)  for  above-
average farm size  

12  

Source: External study 

32  
33  
34  

External study, Annex 3, p LVI. 
External study,p.102. 
External study,p.102. 

24.2  

-  

36.3  

10760  

2603920  

24.2  

16310  

3157616  

4540  

1318416  

Total  

7079952  

51 

 
  
  
  
 
In parallel to the consultation findings, available EU-27 data on agricultural production 
cost structures (based on Eurostat EAA) show that veterinary expenditure has remained 
broadly stable (around 1–2% of total farming costs). This indicates no significant change 
at aggregate level. Reported increases are therefore more likely linked to factors such as 
higher  disease  pressure  and  related  surveillance  needs,  including  the  registration  of 
previously unregistered establishments, rather than to the AHL itself35 

Current survey evidence (Figure 15) shows that farmers perceive the AHL's benefits as 
limited or still emerging, reflecting its early implementation stage and preventive focus. 
Most  respondents  report  no  significant  changes  in  market  opportunities,  cross-border 
trade, regional health status, or disease occurrence/impact. 

However,  17/35  respondents  note  positive  effects  in  disease  prevention  and  control, 
attributing  improvements  to  clearer  rules,  responsibilities,  and  structured  approaches. 
Sector-specific benefits include aquaculture cost savings (~25%) and reduced antibiotic 
use/fewer endemic diseases linked to Article 25 (animal health visits)36. 

Figure 15 – Survey replies to the question ‘In which of the following area(s) did you 
observe (positive or negative) changes due to the adoption of the AHL?’, by livestock 
and aquaculture farmers and industry representatives.  

 Source: External study.  

Additional  qualitative  evidence  indicates  improvements  in  early  disease  detection  and 
overall  animal  health  status,  particularly  through  enhanced  surveillance.  For  example, 
better early detection of avian influenza has helped reduce outbreak impacts in certain 
regions 

Some stakeholders estimate potential cost savings of 10–15%, with some suggesting up 
to 25% due to improved regional health status, though these figures remain difficult to 
verify  and  compare.  Reputational  benefits  have  also  been  noted,  with  one  transport 
association reporting a 15–20% increase in perceived sector value, attributed to stronger 
prevention, biosecurity, and surveillance measures. However, public perception remains 

35  

36  

Eurostat, Economic Accounts for Agriculture (EAA), EU-27 agricultural production cost structure, 
showing veterinary expenditure consistently at around 1–2% of total costs over 2005–2025. 
External study, Annex 3, p. LIX. 

52 

 
 
sceptical, influenced by recurring outbreaks and vaccination concerns, which limits the 
visibility of these benefits. 

Despite progress, 12 out of 35 respondents still report a negative economic impact from 
disease outbreaks, highlighting the ongoing financial burden at the farm level, which can 
outweigh short-term preventive benefits. More broadly, stakeholders acknowledge that 
disease  control  programmes  contribute  to  improved  animal  health,  welfare,  and  food 
safety,  as  well  as  reduced  antibiotic  use  and  disease-related  losses.  However,  these 
benefits remain difficult to quantify and are not yet fully reflected in stakeholders’ overall 
efficiency perceptions. 

For veterinarians, the primary efficiency challenge is increased indirect compliance costs 
and  administrative  workload,  rather  than  changes  in  core  clinical  tasks.  Survey  data 
(Figure 16) from veterinary associations shows that 9 out of 14 respondents report higher 
costs,  particularly  due  to  additional  training  and  professional  development,  reporting 
requirements and adaptation to digital tools (e.g., checklists, databases, on-site systems). 
In  several  Member  States,  veterinarians  highlight  the  lack  of  harmonised  training, 
particularly on biosecurity and implementation, forcing them to seek independent training 
and increasing time and financial costs. Staff shortages further exacerbate these pressures, 
especially in remote areas, where limited veterinary availability raises per-visit costs and 
threatens  the  economic  viability  of  mandatory  animal  health  visits.  This  can  either 
increase costs for farmers or reduce the sustainability of veterinary practices. However, 
these reflect broader structural and organisational challenges in the veterinary sector and 
cannot be directly attributed to the AHL. 

Figure 16 – Survey replies to the question ‘In which of the following area(s) did you 
see a change in costs since the adoption of the AHL?’, by veterinary associations.   

The figure includes only adjustment and administrative cost categories.  

Source: External study.  

The  AHL  has  delivered  mainly  structural  and  operational  benefits  for  veterinarians. 
Surveys, interviews, and workshops indicate clearer responsibilities, more standardised 
disease  control,  and,  in  some  cases,  defined  eradication  criteria  (e.g.  bovine  viral 
diarrhoea). Some veterinarians report improved information exchange (3/14) and earlier 

53 

 
 
alignment on detection and control (6/14)37,enabling timelier interventions and reducing 
outbreak impacts (3/14)38. 

However,  64%  (9/14)  observed  no  measurable  reduction  in  outbreaks  or  economic 
impact,  reflecting  early  implementation,  indirect  benefits,  which  are  less  immediately 
visible or quantifiable and variability across Member States. 

For NCAs, results are mixed (Figure 17), with most reporting no cost changes in crisis 
management (13/23), coordination (15/23), and simulation reporting (14/23)39.  

Figure 17 – Survey replies to the question ‘In which of the following area(s) did you 
see a change in costs since the adoption of the AHL?’, by NCAs.   

The figure includes only administrative and adjustment cost categories.  

Source: External study.  

Cost  increases  were  reported  in  key  operational  areas,  such  as  disease  detection, 
prevention, and monitoring, with 10/23 respondents indicating higher costs. These reflect 
the  AHL’s  preventive,  risk-based  approach  and  the  broader  epidemiological  context. 
Expanded  surveillance,  inclusion  of  wildlife  and  pets,  and  registration  of  previously 
unregistered  establishments  have  increased  staffing,  data  management,  and  laboratory 
needs. Concrete examples from consultations show ~15% cost increases in Poland and 
Austrialinked to wildlife surveillance for African swine fever. The HPAI situation has 
required  reinforced  early  detection  (testing,  reporting,  data  management),  while  in  the 
Netherlands, extended registration obligations increased administrative workload 40..  

Evidence  from  specific  MSs  highlights  significant  implementation  efforts.  Denmark 
required 8–10 man-years plus additional staff (8 FTEs in 2022, 6 in 2023, 3 in 2024)41. 
In  Germany,  one  NCA  recruited  an  extra  FTE  for  surveillance,  while  in  Italy, 
administrative  burden  increased  due  to  fragmented  data  systems  and  complex  EU 
reporting and co-financing procedures. 

37  
38  
39  
40  
41  

External study, p. 102. 
External study, p. 104. 
External study, Annex 3, p. CV. 
External study, Annex 3, p. LI. 
External study, Annex 3, p. LXIV. 

54 

 
 
 
Despite these costs, NCAs report clear structural benefits. Most observed positive effects 
in disease prioritisation (18/23) and from the harmonised EU framework (19/23) as the 
survey indicates (Figure 18). Around half noted improved clarity of rules (12/2342), and 
13/23 reported better biosecurity awareness43, though implementation remains uneven. 

Figure 18 – Survey replies to the question ‘In which of the following area(s) did you 
observe (positive or negative) changes due to the adoption of the AHL?’, by NCAs. 

Source: External study. 

Interview  and  validation  workshop  evidence  shows  the  AHL  has  improved  targeted 
surveillance, resource allocation, transparency, and coordination between Member States, 
supporting consistent disease control and market trust. 

For specific diseases, the AHL has delivered notable benefits. For diseases like IBR and 
BVD, EU disease-free status supports trade and reduces disease related losses. For ASF 
and  HPAI,  benefits  are  systemic:  coordinated  surveillance,  harmonised  rules,  and 
regionalisation enabling targeted control while maintaining trade. 

However,  many  NCAs  report  no  observable  change:  no  reduction  in  outbreak  impact 
(14/23),  no  faster  reaction  times  (17/23),  and  no  lower  coordination  costs  (14/23), 
reflecting early implementation and wider epidemiological factors44.. 

Overall assessment of proportionality 

The  overall  assessment  of  the  AHL’s  proportionality  reveals  significant  variations  in 
perception  across  stakeholder  groups.  Survey  results  77  respondents;  Figure  20)  show 
mixed perceptions: 19 consider benefits outweigh costs, 18 see costs as proportionate, 28 
believe costs outweigh benefits, and 12 are uncertain. 

42  
43  
44  

External study, Annex 3, p. 107. 
External study, p. 107. 
External study, p. 107. 

55 

 
 
 
Farmers and industry representatives tended to view  view costs as outweighing benefits 
(16/35), given the immediate and tangible compliance burdens at the farm level, with only 
4/35  reporting  that  benefits  exceed  costs.  In  contrast,  national  competent  authorities 
(NCAs) offer a more balanced perspective, with 6/9 considering costs either proportionate 
or  outweighed  by  benefits,  while  3/9  believe  costs  exceed  benefits.  Veterinary 
associations  present  mixed  views:  5/14  see  costs  as  proportionate,  5/14  believe  costs 
outweigh benefits, and 4/14 feel benefits surpass costs. Civil society, academia, and other 
organizations  express  the  most  positive  assessment,  with  12/19  stating  that  benefits 
predominant. 
outweigh 

6/19  who 

compared 

costs, 

costs 

see 

as 

to 

These differences reflect the timing and nature of impacts. Costs are front-loaded, visible 
and directly borne by operators and authorities, while benefits are longer-term, structural, 
and preventive, often linked to avoided losses and improved preparedness, making them 
difficult  to  quantify.  Variations  across  MSs  are  further  influenced  by  diverse  starting 
conditions, administrative capacities, epidemiological pressures (e.g., outbreaks of ASF, 
HPAI, BTV), and varying stages of implementation. 

Overall,  the  AHL  shows  potential  for  proportionate  or  net  positive  outcomes  in  the 
medium to long term, contingent on continued implementation, reduced administrative 
burden, and stronger evidence of long-term benefits. 

Figure 19 – Survey responses to the question “To what extent do you consider the 
overall costs of the AHL proportionate to the benefits?”, per stakeholder group. 

Source: External study. 

Administrative burden and complexity remain key concerns under the AHL. Stakeholders 
consulted under the CfE, including farmers and veterinarians highlight its multi-layered 
structure  (basic  Regulation,  delegated/implementing  acts,  national  rules),  leading  to 
interpretation  challenges,  duplicated  reporting  (e.g.  TRACES,  ADIS),  and  continued 
paper-based processes.  

Burden  increased  with  expanded  obligations:  registration  of  new  operators  (e.g. 
Netherlands45),  detailed  record-keeping  (8–12  hours/farmer;  ~EUR  7  million/year), 

45  

External study, Annex 3 p. LXV. 

56 

 
 
 
training  (~EUR  47  million/year46),  and  animal  health  visits  (~EUR  400/farm47). 
Inefficiencies in certification and TRACES (duplication, instability, delays) affect trade. 
Proportionality issues persist (e.g. identical requirements for small/large establishments, 
inconsistent thresholds, sampling delays up to 72h). 

Fragmented systems  and divergent interpretations (e.g. “commercial transport”)  create 
legal uncertainty and duplication across identification and traceability tools (passports, 
vaccination  records,  certificates).  Stakeholders  call  for  better  digital  integration  (e.g. 
TRACES).  Sector-specific  issues  persist,  notably  in  aquaculture,  where  inconsistent 
categorisation  restricts  movements  and  creates  trade  barriers,  with  disproportionate 
requirements for smaller operators.  

Additional  challenges  include  duplicative  reporting,  inconsistent  certification,  delays 
(e.g. breeding), non-risk-based biosecurity measures (e.g. prolonged restriction zones), 
and limited veterinary capacity. NCAs also highlight added complexity from overlap with 
disease-specific rules (e.g. ASF). NCAs confirm increased costs, mainly outbreak-driven 
(~15% Austria; up to 50% Poland), alongside high implementation costs (8/23 NCAs; 
Denmark 8–10 man-years48). 

Overall, these factors have led to short-term inefficiencies - duplication, delays, higher 
workload, limited interoperability, reduced trade, and less time for clinical work. These 
are  largely  transitional,  linked  to  regulatory  layering,  system  fragmentation  and 
proportionality issues, and are expected to decrease with further streamlining, improved 
digital integration, and more proportionate application. 

Reporting obligations and potential for simplification 

The AHL establishes comprehensive reporting obligations (registration, record-keeping, 
notification,  TRACES  movements,  surveillance,  disease-free  status),  widely  seen  as 
necessary for its preventive approach. Most NCAs report no or moderate cost increases 
(e.g. 9/17 no change; 6 increases49), indicating reliance on existing systems. 

Challenges stem mainly from implementation: misaligned national systems, duplication, 
divergent definitions (e.g. “case”, “commercial transport”), fragmented data, and delays 
affecting sectors like aquaculture, transport, and breeding. 

Some  stakeholders  also  highlight  opportunities  for  simplification  and  cost  reduction. 
They emphasise that preventive measures, such as coordinated vaccination, are more cost-
effective than reactive outbreak responses (e.g. France HPAI vaccination (Table 3), €93.6 
million in 2020-202150 vs €1.1 billion outbreak costs).  

Table 3 – Cost distribution for the HPAI vaccination campaign in France 

Activity  

Budget  Share  (%) 
of  the  vaccination 
campaign  

Paid by  

Amount 
EUR mln  

State 
EUR mln  

Farmers 
EUR mln  

46  
47  
48  
49  
50  

External study, Annex 3 p.  LVIII. 
External study, Annex 3 p. LXXXV. 
External study, Annex 3, p. LI. 
External study, Annex 3, p. LXIV. 
External study, Annex 3, p.  LXXXVII. 

57 

 
 
Buying the vaccine  

24  

Vaccine storage and transport   4  

Supervision  of  vaccination 
(official vets)  

18  

State  

State  

22464  

22464  

3744  

3744  

State  

16848  

16848  

0  

0  

0  

Vaccination operations  

27  

State/Farmers  25272  

13204  

12068  

Monthly  visits 
surveillance  

for 

active 

8  

State  

7488  

7488  

Active surveillance analyses   17  

State  

15912  

15912  

0  

0  

Passive surveillance analyses   2  

Farmers  

1872  

0  

1872  

TOTAL  

100%  

93600  

79660  

13940  

Source: External study.  

At  the  same  time,  some  simplifications  are  already  in  place  (e.g.  AHL  Article  139 
derogations).  For  example,  “Alpenweideviehverkehr”  seasonal  cross-border  grazing 
arrangements between Austria, Germany, Switzerland, Liechtenstein, and Italy allowing 
local  livestock  movements  without  full  certification  under  specific  risk-mitigation 
conditions),  showing  how  the  AHL  can  support  pragmatic,  risk-based  solutions  while 
maintaining health safeguards. 

Overall,  simplification 
interoperability, and EU-national alignment, rather than revising core obligations. 

implementation, 

including  digitalisation, 

in  better 

lies 

Limitations 

Assessment is constrained by incomplete national alignment and early implementation 
stage, making impacts hard to isolate and long-term benefits not yet fully visible. 

58 

 
  
 
 
 
4.1.3 Coherence  

The  evaluation  concludes  that  the  AHL  is  overall  coherent,  establishing  a 
consistent, structured, and risk-based legal framework for animal health at the 
EU 
level.  Its  design  based  on  disease  categorisation,  clearly  defined 
responsibilities,  and  integrated  measures  ensures  strong  alignment  between  its 
objectives, instruments, and expected outcomes. 

No significant internal contradictions or overlaps have been identified within the 
AHL  itself.  The  few  reported  issues  relate  primarily  to  technical  elements, 
interpretation, or practical application rather than flaws in the legislative design. 

External coherence is generally strong, particularly with EU food safety, public 
health,  and  internal  market  frameworks,  as  well  as  international  standards. 
However,  partial  misalignments  persist  in  specific  areas,  including  animal 
welfare,  environmental  policy,  financing  instruments,  and  disease-specific 
regimes such as transmissible spongiform encephalopathies (TSE). 

While the AHL demonstrates high legislative coherence, the practical benefits of 
such  coherence  is  not  yet  fully  achieved  due  to  differences  in  national 
implementation,  interpretation,  and  administrative  capacity.  These  divergences 
affect consistency and predictability across Member States. 

Overall,  the  AHL  provides  a  solid  legislative  foundation,  with  remaining 
challenges primarily linked to implementation, policy interactions, and the need 
for further alignment over time. 

This  evaluation  assessed  clarity  and  consistency  both  within  the  AHL  (internal 
coherence)  and  in  relation  to  broader  EU  legislation  and  external  policy  (external 
coherence). 

Internal coherence 

The  AHL  demonstrates  a  satisfactory  level  of  internal  coherence,  with  its  core 
components  (disease  listing,  surveillance,  prevention,  movement  rules,  emergency 
measures)  forming  an  integrated  system  for  disease  control  and  trade.  Most  NCAs, 
veterinarians,  and  operators  report  no  fundamental  contradictions  or  major  overlaps 
within the surveys and interviews. 

Identified  issues  are  limited  and  technical:  e.g.  exclusion  of  hatching  eggs  from 
traceability,  ambiguity  on  “other  veterinarians”  (Article  14(c)(i)),  and  complexity  in 
disease control and disease-free status  (notably  IBR). Some inconsistencies stem  from 
divergent  interpretations  ((e.g.  “disease  prevention”,  “terrestrial  animals”),  delays  in 
implementing  provisions  (e.g.  Article  37)51  and  interaction  with  disease-specific 
measures  (Commission  Implementing  Regulation  (EU)  2023/59452  on  ASF).  Overall, 

51  
52  

External study, p.131. 
Commission  Implementing  Regulation  (EU)  2023/594  of  16  March  2023  laying  down  special 
disease  control  measures  for  African  swine  fever  and  repealing  Implementing  Regulation  (EU) 
2021/605 http://data.europa.eu/eli/reg_impl/2023/594/oj. 

59 

 
 
 
issues  are  primarily 

reflects  evolving 
identified 
epidemiological  needs  rather  than  stemming  from  deficiencies  in  the  design  of  the 
framework.  

implementation-related  or 

External coherence with EU legislation and policies 

The AHL is overall coherent with relevant EU legislation and policies, though coherence 
varies across areas. It provides a structured basis for coordination with food safety, public 
health, and official controls, linking surveillance, notification, traceability, and movement 
rules to support integrated risk management and a One Health approach. 

The AHL is supported by a set of Union-level digital systems, in particular the ADIS and 
TRACES,  which  operate  within  the  broader  framework  of  IMSOC  established  under 
Regulation (EU) 2017/625. These systems link animal health rules with official controls, 
certification,  and  information  exchange,  though  interoperability  gaps  between  EU  and 
national  databases  create  practical  coherence  challenges,  such  as  data  structure 
differences and process duplication. 

The  strongest  coherence  is  with  the  EU  food  safety  and  official  controls  framework, 
where the AHL’s prevention, surveillance, and biosecurity measures support food safety 
objectives  and  align  with  Regulation  (EU)  2019/653  on  veterinary  medicinal  products, 
helping reduce antimicrobial use and combat antimicrobial resistance. 

The  AHL  also  contributes  the  EU  public  health policies,  particularly  Regulation  (EU) 
2022/237154 on cross-border health threats, by strengthening animal disease surveillance 
and  notification,  facilitating  early  detection  and  coordinated  responses  between  public 
health  and  veterinary  authorities.  While  the  AHL  and  public  health  frameworks  have 
distinct objectives, they are mutually reinforcing and support a One Health approach. 

Coherence  with  animal  welfare  legislation  is  more  partial.  While  no  direct  legal 
contradictions  were  identified,  several  stakeholders,  including  NCAs  and  civil  society 
organisations, highlighted operational tensions between  disease control measures (e.g., 
culling,  movement  restrictions)  and  animal  welfare  requirements.  Around  one-third  of 
farmers and industry operators report difficulties in balancing animal health and welfare 
compliance, especially in emergencies, pointing to a need for better coordination of IT 
instruments  like  TRACES  NT  with  Regulation  (EC)  No  1/200555  on  animal  transport 
protection. 

Coherence with EU financing instruments, including Regulation (EU) 2021/69056, is also 
limited.  While  the  AHL  promotes  a  preventive  and  risk-based  approach,  funding 

53  

54  

55  

56  

and 

products 

repealing 

medicinal 

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on 
veterinary 
2001/82/EC, 
http://data.europa.eu/eli/reg/2019/6/oj.  
Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 
repealing  Decision  No 1082/2013/EU, 
on  serious  cross-border 
http://data.europa.eu/eli/reg/2022/2371/oj. 
Council  Regulation  (EC)  No 1/2005  of  22 December  2004  on  the  protection  of  animals  during 
transport  and  related  operations  and  amending  Directives  64/432/EEC  and  93/119/EC  and 
Regulation (EC) No 1255/97, http://data.europa.eu/eli/reg/2005/1/2019-12-14. 
Regulation  (EU)  2021/690  of  the  European  Parliament  and  of  the  Council  of  28 April  2021 
establishing a programme for the internal market, competitiveness of enterprises, including small 

to  health  and 

Directive 

threats 

60 

 
 
mechanisms  are  largely  oriented  towards  emergency  response  and  compensation. 
Stakeholders, including NCAs and civil society, noted that this creates a misalignment 
between policy objectives and financial incentives and called for clearer links between 
prevention measures and funding eligibility. 

Additional  coherence  challenges  arise  from  the  AHL’s  coexistence  with  pre-existing 
in  particular  Regulation  (EC)  No  999/200157  on 
disease-specific  frameworks, 
transmissible spongiform encephalopathies. Stakeholders note that maintaining a separate 
TSE  regime  outside  the  AHL’s  disease  categorisation  system  leads  to  fragmentation, 
complicates prioritisation, and poses practical implementation and funding challenges. 

Coherence of implementation across Member States 

The structural consolidation under Effectiveness supports the AHL’s internal coherence, 
with  its  risk-based  design  aligned  to  prevention  and  control  objectives.  However,  full 
coherence  across  Member  States  is  not  yet  achieved  due  to  differences  in  national 
systems58, administrative capacity, and prior alignment. 

Implementation varies: some Member States (e.g. Spain, Italy, Latvia) required limited 
adjustments,  while  others  (e.g.  Bulgaria,  Austria,  Hungary,  Denmark)  needed  more 
substantial  reforms.  Survey  results  show  40/91  respondents  identified  divergences  in 
interpretation  and  application,  affecting  consistency  and  predictability  of  cross-border 
movements (Figure 20). 

Figure 20 – Survey replies  to  the  question  ‘Have  you  identified  any  diverging 
provisions, interpretations and /or application issues between AHL and the animal 
health measures and systems in your country?’  

Source: External study.  

Despite these challenges, the AHL provides a common legal framework that facilitates 
coordination  and  gradual  convergence.  Remaining  issues  relate  to  differences  in 

and medium-sized enterprises, the area of plants, animals, food and feed, and European statistics 
(Single Market Programme) http://data.europa.eu/eli/reg/2021/690/oj. 
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 
encephalopathies, http://data.europa.eu/eli/reg/2001/999/oj. 
External study, Annex 3, p.  CXXXVIII. 

57  

58  

61 

 
 
 
administrative capacity,  legal  traditions,  and coexistence with  legacy frameworks (e.g. 
TSE, zoonoses). 

Overall,  the  AHL  has  improved  coherence  at  EU  level,  while  practical  integration  at 
national level remains ongoing. 

International coherence and harmonisation 

The AHL aligns with WOAH standards, serving as a science-based reference for disease 
prevention,  control,  and  trade.  It  supports  harmonisation  of  sanitary  requirements, 
particularly for imports into the EU, with third countries often adapting their systems to 
meet EU standards (e.g. Switzerland).  

The AHL is also coherent with the EU’s obligations under the WTO Agreement on the 
Application of Sanitary and Phytosanitary Measures (SPS), as its risk-based approach, 
including regionalisation, reflects internationally recognised standards and contributes to 
predictable trade conditions.  It also contributes to WTO SPS discussions (ASF, HPAI).  

However, global impact remains moderate: alignment by third countries is voluntary and 
market-driven.  Many  prioritise  bilateral  arrangements  over  EU  rules,  limiting  AHL 
influence on exports, while its role remains stronger for import standards. 

Cooperation, information exchange and joint response 

The  AHL  has  strengthened  international  cooperation,  particularly  with  WOAH, 
improving  information  exchange  on  animal  diseases.  The  integration  of  ADIS  with 
WOAH  WAHIS  enhances  data  exchange  timeliness  and  completeness,  supporting 
transparency  and  coordinated  responses  to  transboundary  diseases.  Stakeholders  also 
highlight the AHL’s role in sharing scientific information through EFSA, which plays a 
key role in risk assessment and communication. However, further improvements could 
be achieved by proactively promoting the AHL internationally. 

Regarding  the  “Do  No  Significant  Harm”  principle,  the  AHL  has  largely  neutral 
environmental effects, with some benefits for wildlife surveillance and early detection. 
However, control measures for major diseases (e.g. ASF, avian influenza) may conflict 
with biodiversity objectives (e.g. culling, restrictions). Stakeholders also note challenges 
in wildlife surveillance, due to ecological complexity and resource constraints, as well as 
limited  links  with  broader  EU  environmental  policies,  such  as  the  Circular  Economy 
Action  Plan.  While  one  national  competent  authority  suggested  potential  circularity 
opportunities  through  disease  monitoring,  civil  society  and  academic  stakeholders 
emphasised the need for stronger coordination between animal health and biodiversity 
policies. 

Coherence with EU strategic objectives and One Health 

The AHL is conceptually aligned with key EU strategic frameworks, including the One 
Health  approach  and  the  Long-Term  Vision  for  Rural  Areas.  It  contributes  primarily 
through strengthened disease prevention, harmonised rules, and support for the internal 
market. However, stakeholder perceptions vary: civil society and academia view the AHL 
as  making  a  significant  contribution  to  sustainability,  particularly  through  improved 
biosecurity  and  resilience,  while  NCAs,  farmers,  and  industry  representatives  see  its 
impact  as  moderate,  citing  uneven  implementation  and  limited  integration  with 

62 

 
environmental  and  rural  development  policies.  Around  half  of  farmers  and  industry 
stakeholders perceive a clear contribution to the Long-Term Vision for Rural Areas. 

The AHL supports the internal market by harmonising animal health requirements and 
enabling safe intra-EU movements, thereby underpinning the competitiveness of the food 
sector.  However,  differences  in  national  implementation  and  enforcement  create 
challenges for maintaining a level playing field and can undermine confidence in cross-
border equivalence. 

The AHL reflects the One Health approach by recognising the interconnection between 
animal and human health, strengthening surveillance, prevention, and early detection of 
pathogens. Through harmonised disease notification requirements and the ADIS system, 
including its interoperability with WAHIS, the AHL enhances data sharing, transparency, 
and early warning, facilitating risk assessment and coordinated responses, particularly for 
zoonotic diseases. However, implementation remains partial, with limited environmental 
integration  and  structured  cross-sectoral  cooperation  between  animal  health,  human 
health  and  environment  sectors.  Public  health  officials  note  that  the  AHL’s  disease 
categorisation,  while  useful  for  animal  health  management,  is  insufficient  to  fully 
operationalise  a  comprehensive  One  Health  approach.  Emerging  zoonotic  diseases 
requiring  transnational  and  interdisciplinary  responses  are  not  always  adequately 
addressed within national intervention priorities. 

Additionally, wildlife surveillance under the AHL remains largely focused on listed 
diseases (e.g., ASF, rabies, avian influenza), with complementary initiatives like 
ENETWILD59 aiming to improve harmonised surveillance of zoonotic diseases in 
wildlife. Stakeholders emphasise the need for stronger cross-sectoral integration to fully 
realise the One Health approach in practice. 

Overall, the AHL is coherent with EU strategic objectives and supports the One Health 
approach,  though  further  efforts  are  needed  to  strengthen  practical  integration  across 
policy  areas  and  ensure  more  consistent  implementation.  The  AHL  provides  a  robust 
legislative  framework,  with  remaining  challenges  primarily  operational,  relating  to 
national implementation differences, partial policy alignment, and the need for stronger 
cross-sectoral coordination. These challenges do not undermine the overall coherence of 
the  framework  but  highlight  areas  for  further  alignment,  guidance,  and  coordination 
across the EU. 

4.2   How did the EU intervention make a difference and to whom? 

The evaluation finds that the AHL delivers clear EU added value by providing a 
common animal health framework that Member States could not have achieved 
as effectively through separate national action. This is particularly evident in the 

59  

ENETWILD is an initiative coordinated by the European Food Safety Authority that supports the 
harmonised collection, analysis and sharing of data on wildlife populations and wildlife diseases 
across  the  EU.  It  develops  methodologies  and  provides  data  to  improve  risk  assessment  and 
surveillance of zoonotic and emerging diseases at the wildlife–livestock–human interface, thereby 
contributing to the implementation of the One Health approach; Home - Enetwild. 

63 

 
 
management of transboundary animal diseases and in safeguarding the smooth 
functioning of the internal market for animals and animal products. 

Common EU rules on surveillance, traceability, animal movements and disease 
control  enable  coordinated  action,  faster  responses  to  outbreaks  and  greater 
mutual trust between Member States. Tools such as regionalisation further help 
contain disease risks while preserving trade continuity where justified. 

While  differences  in  national  implementation  can  affect  the  consistency  of 
outcomes, they do not undermine the overall added value of EU action. Overall, 
the AHL provides substantial benefits in terms of effectiveness, legal certainty and 
market confidence that go beyond what national measures alone could reasonably 
deliver. 

The evidence indicates that the AHL has achieved the objective of ensuring coordinated 
and effective animal health management across Member States to a large extent. Its core 
contribution lies in establishing a single, harmonised framework for disease prevention, 
surveillance,  control,  animal  movements  and  certification  across  the  Union.  In  the 
targeted survey, a large majority of respondents (see Figure 21) confirmed that all key 
stakeholder  groups  consider  that  comparable  results  could  not  have  been  achieved 
through national action alone (81% overall), including 18 out of 23 national competent 
authorities  (NCAs),  30  out  of  35  farmers  and  industry  representatives,  9  out  of  14 
veterinary  associations  and  17  out  of  19  civil  society  and  research  organisations.  In 
addition, 30 out of 35 industry respondents indicated that maintaining current levels of 
intra-EU  movements  without  increasing  disease  risks  would  not  be  feasible  without  a 
harmonised EU framework. 

Figure  21  –  Survey  replies  to  the  question  ‘Could  the  same  results  have  been 
achieved  by  national  animal  health  measures  and  systems  alone,  without  the  EU 
AHL?’ 

Source: External study (N= 91) 

The  added  value  of  EU  action  is  particularly  evident  in  areas  requiring  cross-border 
coordination.  National  competent  authorities and industry stakeholders  highlighted the 
importance  of  regionalisation  and  compartmentalisation,  which  allow  the  safe 
continuation of trade from  unaffected  areas during outbreaks. Stakeholders  referred in 

64 

 
 
particular to France’s experience60 during highly pathogenic avian influenza outbreaks, 
where these tools helped preserve trade continuity while containing disease risks. 

National  authorities  and  veterinary  stakeholders  also  emphasised  the  role  of  common 
traceability  and  notification  systems,  notably  ADIS,  in  enabling  timely  information 
exchange  and  coordinated  responses  between  Member  States.  Industry  representatives 
and competent authorities further pointed to harmonised EU rules and model certificates 
as  important  factors  supporting  transparency,  credibility  and  recognition  in  trade  with 
third  countries.  Practitioners  also  underlined  wider  system  benefits,  including  clearer 
allocation  of  responsibilities  for  operators  and  a  common  legal  basis  facilitating  the 
integration of wildlife surveillance into preparedness and contingency planning. 

These  mechanisms  generate  benefits  across  stakeholder  groups.  Competent  authorities 
benefit  from  predictable  coordination  tools  and  common  rules;  operators  and  farmers 
from greater market stability and fairer competitive conditions; veterinarians from more 
harmonised practices across Member States; and civil society and research organisations 
from stronger confidence in animal and public health protection. 

Some limitations nevertheless affect the extent to which EU added value is fully realised 
in practice. Differences in national implementation and the use of flexibility provisions 
can  affect  the  predictability  of  animal  movements  and  create  uneven  conditions  for 
operators. In addition, given that the AHL has applied fully only since 2021, further time 
and  evidence  will  be  needed  to  assess  its  full  impact  on  longer-term  animal  health 
outcomes and trade flows. 

Proportionality and balance between EU and national action 

The evaluation finds that the balance between EU action and national flexibility is broadly 
appropriate and proportionate. The AHL establishes common Union rules while allowing 
Member States to adapt  measures to national  epidemiological conditions  through risk-
based approaches, regionalisation and targeted derogations. Consultation evidence shows 
broad  agreement  across  stakeholder  groups  that  such  a  harmonised  framework  is 
necessary, given the cross-border nature of animal diseases and the need to safeguard the 
internal market. 

Overall, the framework is considered justified at EU level, with challenges arising 
mainly from implementation rather than from the design of the framework itself. 
The  main  issue  identified  is  the  need  to  ensure  that  national  implementation  remains 
sufficiently  aligned  to  preserve  coherence,  predictability  and  mutual  trust  across  the 
Union. 

Areas for further strengthening  

While  the  AHL  delivers  clear  EU  added  value,  stakeholders  identified  targeted 
opportunities to further strengthen EU-level action. Farmers and industry representatives 
emphasised the value of concise, sector-specific guidance adapted to different production 
systems.61 National authorities and veterinarians also called for greater consistency across 
Member  States,  while  preserving  necessary  flexibility,  including  stronger  minimum 
biosecurity baselines and better exchange of good practices through practical guidance, 

60  
61  

External study, Annex 3, p. CCLIV. 
External study, Annex 3, p VIII. 

65 

 
 
case libraries and peer learning.62 Strengthening implementation capacity, in particular 
through  more  effective  use  of  the  veterinary  workforce  and  improved  access  to 
consolidated EU guidance, was also identified as a priority. These improvements would 
enhance  the  effectiveness  of  the  framework  without  calling  into  question  its  overall 
design or added value.63 

4.3  

Is the intervention still relevant? 

The  evaluation  finds  that  the  AHL  remains  relevant  to  current  and  emerging 
animal health challenges. Its risk-based and flexible design enables it to respond 
to  changing  epidemiological  conditions,  including  pressures  linked  to  climate 
change, wildlife reservoirs and global trade. 

Stakeholders  broadly  confirm  its  relevance,  though  more  mixed  views  from 
farmers, industry and veterinarians reflect practical implementation challenges. 

The framework provides a coherent, integrated approach and has demonstrated 
adaptability in recent outbreaks. 

Remaining  challenges  relate  mainly  to  implementation.  Differences  in  national 
systems,  capacity  and  digitalisation  create  fragmentation,  duplication  and 
administrative burden. These issues stem primarily from implementation rather 
than  the  AHL’s  legal  design.  Overall,  the  AHL  remains  fit  for  purpose,  while 
requiring targeted adjustments and effective implementation in a changing risk 
environment. 

Relevance and fitness for purpose 

The objective of the AHL is to provide a comprehensive, risk-based framework capable 
of  addressing  current  and  emerging  animal  health  challenges.  The  available  evidence 
indicates that this objective remains broadly valid and that the framework continues to be 
relevant and fit for purpose. 

Consultation results (see Figure 22) show that 53 out of 91 respondents (58%) considered 
the AHL’s provisions fit for purpose, including 14 respondents to a large extent and 39 
to a moderate extent. Support nevertheless varies across stakeholder groups. The most 
positive assessments were recorded among national competent authorities, where 21 out 
of 23 respondents expressed a positive view, including a relatively high share to a large 
extent (8 respondents). Civil society, academia and other organisations active in animal 
health also reported strong support, with 15 out of 19 respondents (79%) considering the 
AHL fit for purpose. 

Views  among  farmers,  industry  representatives  and  veterinary  associations  were  more 
mixed,  with  a  greater  share  indicating  that  the  framework  is  fit  for  purpose  only  to  a 
limited extent. This suggests broad recognition of the continued relevance of the AHL, 

62  
63  

External study, Annex 3, p V. 
Foundational work for this has been provided by Duarte et al. (2025, Methods to assess on-farm 
biosecurity  in  Europe  and  beyond.  Preventive  Veterinary  Medicine  239:  106486),  offering  a 
comprehensive overview of biosecurity assessment methods in Europe. 

66 

 
 
 
while  highlighting  differing  perceptions  linked  to  practical  implementation  experience 
and regulatory burden. 

Figure 22 – Survey replies to the question ‘To what extent do you find the provisions 
of the AHL fit and relevant to the current animal health challenges?’ 

Source: external study (N= 91).  

The  AHL’s  continued  relevance  stems  from  its  comprehensive  and  forward-looking 
design.  By  integrating  prevention,  preparedness,  surveillance,  movement  controls  and 
disease management within a single framework, it replaced fragmented disease-specific 
legislation with a more coherent and risk-based approach. Stakeholders widely consider 
this  better  suited  to  addressing  increasingly  complex  risks,  including  emerging  and 
vector-borne  diseases.  The  framework  also  supports  safe  intra-EU  movements  by 
reducing the risk of divergent national measures disrupting trade and the internal market. 
Stakeholders  nevertheless  emphasised  that  sufficient  flexibility  remains  necessary  to 
respond to evolving epidemiological conditions. 

The framework appears broadly adaptable across Member States, although differences in 
administrative capacity and existing systems affect the speed with which some key risk-
based elements are operationalised. While some countries, e.g. Ireland, Germany, France, 
Italy  and  the  Netherlands,  have  already  operationalised  key  elements  such  as  animal 
health visits and biosecurity, others are still adapting their frameworks. 

Disease categorisation is also widely regarded as a key lever for supporting harmonised 
and proportionate action. However, for certain diseases, divergent national approaches to 
vaccination and control continue to create challenges for intra-EU movements, indicating 
scope for further alignment potentially to the detriment of the flexibility. 

Training and knowledge dissemination also contribute to continued relevance. The BTSF 
programme is widely valued by competent authorities, while stakeholders emphasise the 
need  for  continued  practical  guidance  and  training,  particularly  for  operators  facing 
evolving risks. 

Capacity to adapt to evolving threats 

A key objective of the AHL is to provide a flexible framework capable of responding to 
evolving animal health threats. The available evidence indicates that this objective has 
been largely achieved. By combining a basic regulation with delegated and implementing 

67 

 
acts, the AHL allows rules to be updated in light of scientific evidence and operational 
experience.  Stakeholder  consultations  and  case  studies  indicate  that  this  design  has 
enabled adjustments to surveillance, prevention and control measures during outbreaks 
while maintaining alignment with epidemiological risks. 

For  example,  Delegated  Regulation  (EU)  2020/68764  was  amended  to  improve  the 
proportionality and coherence of disease control measures and to reflect new scientific 
evidence  and  outbreak  experience,  illustrating  the  framework’s  capacity  to  adapt  over 
time.  The  disease  listing  and  categorisation  system  further  strengthens  adaptability  by 
linking measures to risk. Diseases requiring harmonized Union intervention (Categories 
A and B), such as ASF, FMD and HPAI, trigger rapid and coordinated responses across 
Member States. For other diseases (Categories C, D and E), the framework allows greater 
flexibility,  enabling  Member  States  to  tailor  measures  to  national  epidemiological 
conditions and available resources. 

Recent  outbreaks  demonstrate  the  practical  value  of  this  approach.  Large-scale  HPAI 
outbreaks,  including  in  France  and  the  Netherlands,  led  to  additional  control  and 
vaccination  strategies,  while  the  emergence  of  new  bluetongue  virus  (BTV-3)  strains 
required adjustments to surveillance and movement rules. Compared with the previous 
disease-specific directives, the AHL provides a more coherent and risk-based system for 
adapting measures to changing epidemiological developments. 

At  the  same  time,  flexibility  for  certain  Category  C,  D  and  E  diseases  has  resulted  in 
varying national approaches (see Box 3), particularly for diseases involving vectors or 
wildlife  reservoirs.  Differences  in  vaccination  strategies,  surveillance  systems  and 
movement requirements have created inconsistencies across Member States. For intra-
EU  movements,  this  has  generated  practical  challenges,  including  divergent  health 
conditions  between  origin  and  destination  countries,  additional  administrative 
requirements and, in some cases, trade disruptions. 

Box 3 – Bluetongue virus65  

Bluetongue  virus  is  present  in  several  Member  States  and  illustrates  both  the 
adaptability of the AHL framework and the challenges created by divergent national 
implementation. In 2023, BTV-3 emerged in the Netherlands, severely affecting sheep 
populations and causing morbidity and mortality in cattle. BTV-3 outbreaks in Belgium 
and Germany also led to the loss of disease-free status, while Spain continued to report 
BTV-1 and BTV-4. 

As a Category C disease, bluetongue allows Member States to apply measures aimed 
at preventing spread to disease-free areas or those operating eradication programmes. 
This  flexibility  has  enabled  national  responses  tailored  to  local  epidemiological 
conditions, including different vaccination and control strategies. 

64  

65  

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, http://data.europa.eu/eli/reg_del/2020/687/oj. 
External study, p. 145. 

68 

 
 
However, these differing approaches have also created challenges for intra-EU animal 
movements. Under Delegated Regulation (EU) 2020/68866, movements may take place 
under  agreed  health  conditions,  but  these  conditions  can  vary  between  origin, 
destination  and  transit  Member  States.  Stakeholders  reported  that  this  has  created 
complexity, legal uncertainty and, in some cases, trade disruption. 

During consultations, certain stakeholders called for a more harmonised EU approach 
to  bluetongue  management.  Views  differed  on  whether  this  should  involve 
reclassification  of  BTV-3,  broader  changes  covering  multiple  serotypes,  or  more 
uniform pre-movement health requirements. 

In addition, the coexistence of the AHL with certain disease-specific frameworks, notably 
TSEs and Salmonella, has in some cases created overlaps that are not fully aligned with 
the AHL’s  risk-based approach, resulting  in  additional burden and reduced coherence. 
For  example,  the  Netherlands  reported  around  EUR  4.2  million  in  extra  BSE/TSE 
monitoring costs in 2024, partly linked to BTV-3 outbreaks that increased the number of 
animals subject to routine testing and raised expenditure by around 20%67. These issues 
appear to stem mainly from interactions between policy frameworks and implementation 
arrangements rather than from shortcomings in the design of the AHL itself. 

Issues requiring further attention 

Only a limited number of issues requiring further attention were identified, i.e. vector-
borne diseases such as BTV that illustrate clearly the need for continued coordination, as 
divergent national approaches to surveillance, vaccination and movement restrictions can 
create  frictions  for  intra-EU  movements.  Stakeholders  also  identified  practical 
improvements to ADIS, noting that simplified pre-notification followed by updates could 
improve timeliness during urgent situations. 

The interaction between the AHL and wider EU policies, particularly on antimicrobial 
use, was also raised. Some veterinarians and livestock representatives expressed concerns 
that  rigid  implementation  of  reduction  measures  may  in  specific  cases  constrain 
professional judgement. These concerns relate primarily to policy interaction rather than 
the design of the AHL itself. 

Overall, the AHL remains relevant and fit for purpose. The remaining issues identified 
are  targeted  and  operational  in  nature,  pointing  mainly  to  the  need  for  continued 
coordination,  practical  simplification  and  effective  implementation  support  across  the 
Union.  

What are the conclusions and lessons learned? 

5.1   Conclusions 

66  

67  

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, 
http://data.europa.eu/eli/reg_del/2020/688/oj. 
External study, Annex 3, p. 146. 

69 

 
 
This evaluation finds that the AHL has been effective in establishing a modern, coherent 
and risk-based framework for animal health in the Union, replacing a fragmented set of 
disease-specific rules with a more integrated legislative architecture. Its core mechanisms, 
linking  disease  listing  and  categorisation  to  proportionate  surveillance,  movement 
conditions and control  measures, provide a structured basis for coordinated action and 
contribute  to  improved  predictability  in  disease  management  across  Member  States. 
Regardless, these conclusions should be read considering the methodological limitations 
of the evaluation and the relatively short period since the AHL became applicable in 2021. 
Some  effects,  especially  those  linked  to  structural  improvements  in  prevention  and 
preparedness, are likely to become more visible as implementation continues. 

The AHL has strengthened disease prevention and control through enhanced surveillance, 
clearer notification obligations, EU-wide tools such as ADIS, reinforced biosecurity and 
clearer responsibilities for authorities, operators and veterinarians. It also provides a solid 
framework  for  vaccine  banks,  vaccination,  regionalisation  and  compartmentalisation, 
supporting more targeted outbreak responses. However, effectiveness is constrained by 
uneven  implementation  across  Member  States.  Differences  remain  in  surveillance, 
timeliness  of  notification,  preventive  measures  and  use  of  flexibility  tools.  The  wider 
legal framework and uneven dissemination of guidance have also affected understanding 
and  consistent  application  in  some  cases.  Overall,  while  the  AHL  has  significantly 
improved  EU  prevention,  preparedness  and  coordinated  disease  control,  its  full 
effectiveness  depends  on  more  consistent  implementation  and  sufficient  national 
capacity. 

Regarding efficiency, the AHL has simplified and harmonised important administrative 
procedures,  notably  through  clearer  rules  for  establishment  registration  and  approval, 
harmonised health documentation, and EU-level IT systems that support coordination and 
reporting.  Efficiency  gains  remain  uneven,  however,  due  to  differing  administrative 
practices,  legacy  systems  and  varying  veterinary  and  laboratory  capacity.  Certain 
preventive  obligations,  such  as  animal  health  visits  and  additional  registration 
requirements, created additional costs, especially where such measures were previously 
absent.  These  costs  appear  broadly  proportionate  to  the  benefits,  though  quantitative 
evidence remains limited. 

The AHL remains highly relevant in the current epidemiological and policy context. It 
addresses  increasing  disease  pressures,  evolving  risks  and  growing  trade  complexity 
through a preventive and risk-based approach. Recent outbreaks of ASF, HPAI, FMD and 
LSD confirm the continued need for a coordinated EU framework. The AHL is also well 
aligned with broader EU objectives, notably the One Health approach. 

The  evaluation  finds  a  high  degree  of  internal  coherence,  with  disease  categorisation 
creating  a  structured  link  between  surveillance,  movement  conditions  and  control 
measures.  External  coherence  with  the  Official  Controls  Regulation,  food  safety  and 
zoonoses legislation, veterinary medicinal products and feed legislation is overall strong. 
Some  operational  interfaces,  particularly  with  animal  welfare  rules,  e.g.  when 
implementing disease control measures such as movement restrictions and culling during 
outbreaks, can nevertheless create practical challenges. 

The  evaluation  confirms  the  clear  EU  added  value  of  the  AHL.  Harmonised  rules  on 
surveillance,  prevention,  control,  movements  and  entry  into  the  Union  support 
coordinated action, a level playing field and safe trade. Union-level tools such as disease 

70 

 
categorisation,  vaccine  banks,  ADIS,  EU  laboratory  networks  and  regionalisation 
underpin  effective  cross-border  coordination.  Requirements  for  entry  into  the  Union 
broadly mirror EU standards and are consistent with WOAH standards and WTO/SPS 
principles. These results could  not  have been achieved to  the same extent  by Member 
States acting alone. 

Taken together, the AHL has significantly strengthened the EU animal health framework 
by shifting the focus towards prevention, improving preparedness and creating a more 
coherent  legislative  structure.  Its  full  benefits,  however,  depend  on  consistent 
implementation  and  sufficient  administrative  and  operational  capacity  across  Member 
States.  Given  the  recent  application  of  the  framework  and  phased  adoption  of 
implementing  measures,  not  all  intended  effects  can  yet  be  fully  observed.  Continued 
monitoring therefore remains important. 

5.2   Lessons learned 

Implementation to date has shown in this evaluation that the AHL provides a strong and 
modern framework for EU animal health policy. At the same time, several lessons emerge 
for the continued functioning of the complex, risk-based EU regulatory system: 

Strengthening  the  single  policy  and  legal  framework:  the  AHL  has  established  a 
clearer  and  more  coherent  legal  structure.  However,  the  number  and  complexity  of 
delegated and implementing acts, combined with uneven national alignment, can affect 
accessibility,  legal  clarity  and  consistent  application.  Continued  efforts  to  improve 
guidance,  explain  links  between  legal  acts  and  raise  stakeholder  awareness  remain 
important. 

Clarifying  responsibilities  of  different  actors  and  strengthening  compliance:  the 
AHL  has  strengthened  the  allocation  of  responsibilities.  However,  outbreak  situations 
show  that  effective  implementation  also  depends  on  clear  coordination  arrangements, 
operational planning and a common understanding of roles. Differences in enforcement 
and sanctioning approaches can also affect consistency. 

Disease categorisation needs to stay responsive to changing risks: the disease listing 
and  categorisation  system  provides  a  strong  basis  for  proportionate  and  science-based 
measures. 
to 
epidemiological  risks,  including  emerging,  vector-borne  and  wildlife-related  diseases, 
and to different regional contexts. 

Its  continued  effectiveness  depends  on 

responsive 

remaining 

Preparedness  requires  regular  updating  and  testing:  the  AHL  has  strengthened 
contingency planning and crisis-management tools. Their effectiveness depends on plans 
being  regularly  updated,  practically  tested  and  supported  by  sufficient  veterinary  and 
administrative capacity across Member States. 

Regionalisation  and  compartmentalisation  require  consistent  use:  these  tools  can 
support more targeted disease control while helping maintain movements and trade. Their 
benefits depend on a common understanding and consistent application by authorities and 
operators, including recognition by trading partners where relevant. 

71 

 
Ensuring consistent and proportionate implementation while reducing complexity:  
the AHL’s risk-based approach and flexibility are key strengths, allowing measures to be 
tailored to different epidemiological situations. At the same time, differences in the use 
of  derogations,  national  measures  and  interpretation  have  contributed  to  uneven 
implementation,  which  may  affect  consistency  and  the  level  playing  field  within  the 
internal market. While the AHL has simplified and modernised the previous framework, 
administrative  burden  and  complexity  may  persist  where  national  rules  diverge  or 
additional  requirements  are  introduced.  This  underlines  the  importance  of  consistent 
implementation,  clear  understanding  of  available 
flexibilities  and  continued 
simplification in practice. 

Prevention depends on implementation capacity: the stronger focus on prevention is a 
central feature of the AHL. However, implementation of preventive measures, including 
biosecurity,  vaccination,  surveillance  and  animal  health  visits,  remains  uneven  and  is 
closely linked to resources, in particular national veterinary and administrative capacity. 
Experience  to  date  suggests  that  the  benefit  of  the  preventive  approach  depends  on 
consistency across MS. 

Effective  vaccination  requires  practical  readiness:  the  AHL  enables  a  broader  and 
more flexible use of vaccination, which has already contributed to mitigating the impact 
of certain diseases as well as establishment of the vaccine banks against several diseases. 
At  the  same  time,  practical  challenges  remain,  including  availability  of  vaccines, 
logistical  constraints and broader conditions  affecting uptake and deployment, such as 
wider acceptance of commodities from a vaccinated animal population by certain trading 
partners. 

Funding directly influences implementation: experience with the AHL indicates that 
the distribution of costs between operators, national authorities, Member States and the 
Union have a direct impact on incentives, acceptance and the practical implementation of 
preventive and outbreak-related measures. This is particularly relevant for farmers and 
other  operators  affected  by  movement  restrictions,  culling,  mandatory  biosecurity 
upgrades, additional registration requirements or animal health visits. Where costs linked 
to prevention or disease control are perceived as disproportionate, or where compensation 
and support arrangements lack predictability, this may affect willingness to invest early 
in preventive measures, timely reporting of suspicions or broader acceptance of control 
actions.  Differences  in  national  financing  and  compensation  systems  may  also  create 
uneven  implementation  conditions  across  Member  States.  Experience  to  date  suggests 
that stable, predictable and sufficiently targeted financial support can play an important 
role  in  supporting  compliance,  preparedness  and  the  effective  functioning  of  the 
framework across the Union. 

Coherence  benefits  from  continued  cross-sector  cooperation:  the  AHL  is  broadly 
coherent with related EU frameworks and provides a strong basis for applying the One 
Health approach through animal disease surveillance, prevention and control. At the same 
time,  fully  operationalising  One  Health  in  practice  depends  on  effective  cooperation 
across animal,  human  and environmental health systems,  particularly  for  zoonotic and 
wildlife-related risks, where cross-sectoral coordination remains uneven. While overall 
alignment is strong, certain interfaces with pre-existing rules, notably on animal welfare, 
TSEs and zoonoses, may still affect the clarity and efficiency of the wider framework. 

72 

 
Annex I. Procedural Information 

1.  Lead DG, Decide Planning / CWP references 

The evaluation was led by DG SANTE and overseen by an Inter-Service Steering 
Group (ISSG), co-chaired by DG SANTE. It was registered in the DECIDE/Agenda 
Planning database under reference PLAN/2023/2653 and is listed in the 2026 
Commission Work Programme as the “Report from the Commission to the European 
Parliament and to the Council on the evaluation of Regulation (EU) 2016/429 on 
transmissible animal diseases (‘Animal Health Law’)”. 

2.  Exceptions to the Better Regulation Guidelines 

No exceptions were made to Better Regulation Guidelines during this Evaluation. 

3.  Organisation and timing 

An Inter-Service Coordination Group (ISCG) assisted DG Health and Food Safety in 
the evaluation process. The ISSG included Commission services from the Secretariat-
General, the Legal Service, DG TRADE, DG ENV, DG AGRI, DG MARE and DG 
GROW. In total, six meetings were held in relation to the evaluation of the Animal 
Health Law, with the final meeting taking place on 13 April 2026. During this meeting, 
the ISSG discussed the draft Staff Working Document (‘SWD’) and the draft final 
report. Several Commission services provided written comments on the evaluation 
documents. These comments were taken into account in the revised version of the SWD 
and its annexes. 

4.  Evidence and sources 

The  evidence  underpinning  this  Staff  Working  Document  (SWD)  is  drawn  from  an 
external  evaluation study, a call for evidence, and targeted consultation  activities. The 
evidence base consists of two main components: analysis of available documentation and 
stakeholder consultation. 

The SWD is primarily informed by an evaluation study carried out by an independent 
contractor  under  framework  contract  No  SANTE/2024/G2/007  -  SI2.919570  (“Study 
supporting  the  Evaluation  of  the  EU  Animal  Health  Law”).  The  study  was  conducted 
between  September  2024  and  October  2025  under  the  guidance  of  the  Inter-Service 
Coordination Group (ISSG). 

Its  objective  was  to  collect  and  analyse  data  to  support  the  European  Commission’s 
evaluation of the Animal Health Law (AHL), with a particular focus on the five Better 
Regulation criteria: effectiveness, efficiency, relevance, coherence and EU added value. 
This assessment examines the extent to which the legislation functions in practice across 
Member  States  and  for  relevant  stakeholders,  identifying  both  strengths  and  areas  for 
improvement, in line with Article 282. 

The study covers the implementation of Regulation (EU) 2016/429 over the period 2016–
2024, with a primary focus on its application since 21 April 2021. The geographical scope 
includes  all  27  EU  Member  States,  with  more  limited  consideration  of  European 
Economic Area (EEA) countries and candidate countries. 

73 

 
Additional evidence is drawn from a call for evidence launched in March 2024, which 
gathered input from 942 stakeholders. This input supports the identification of key issues 
and informs ongoing reflections on potential improvements to the AHL framework. 

Several policy areas interact with the AHL and influence its practical implementation. 
The Official Controls Regulation establishes the framework for enforcement of animal 
health measures, while IT systems within IMSOC, including TRACES and ADIS, create 
operational  interdependencies  in  both  routine  activities  and  disease  outbreaks, 
significantly  contributing  to  procedural  simplification.  Although  governed  partly  by 
separate legal frameworks, these systems are integral to disease notification, traceability 
and enforcement, and therefore directly affect the functioning of the AHL. 

The AHL also contributes to the EU’s One Health approach, notably through coordinated 
surveillance, data sharing and risk assessment for zoonotic diseases, requiring interaction 
with public health authorities and laboratory networks. 

Interfaces with sanitary and phytosanitary (SPS) rules are relevant for import conditions, 
listing  of  third  countries  and  establishments,  and  intra-EU  movements  of  animals  and 
animal products. 

Environmental legislation is considered only where it directly affects operational aspects 
of  disease  control,  such  as  wildlife  disease  management  or  the  disposal  of  animal  by-
products during outbreak response. 

Other areas, such as animal welfare, veterinary medicinal products, residue monitoring, 
food safety and plant health, interact with specific aspects of disease management but do 
not materially alter the core obligations of the AHL. EU financial support under the Single 
Market Programme (SMP) is considered where it directly supports implementation, for 
example through co-financing of eradication programmes or emergency measures. 

This delineation ensures that the evaluation remains focused on the performance of the 
AHL  itself,  in  line  with  Better  Regulation  principles.  Only  interactions  that  have  a 
substantive impact on effectiveness, efficiency, relevance, coherence or EU added value 
are assessed. 

74 

 
Annex II. Methodology and Analytical models used 

The methodology of the SWD evaluation is mixed methods. This is an approach that uses 
both  quantitative  and  qualitative  data  sources  in  harmony  to  answer  and  affect  the 
outcome of the evaluation. The chosen approach has certain strengths and disadvantages, 
that this annex will cover. 

The  strengths  are  better  and  more  comprehensive  insights  to  the  evaluation.  This 
heightened insight is key to understand the extend of the performance and the depth of 
how it functions, which is not possible under just quantitative or qualitative methods. This 
also  allows  for  flexible  by  being  less  strict  on  the  methods  and  higher  validity  and 
reliability through triangulation. As the requirements of the evaluation is to produce sound 
knowledge in depth  

The disadvantage to the approach lies in the higher complexity, resources and troubles 
with the analytical framework. Integrating both qualitative and quantitative approaches 
requires a data integration, which is both complex and resource demanding. If the data 
integration is not done properly through triangulation both validity and reliability will be 
low. Additionally, there is a risk of potential bias due to nature of interpretation of both 
quantitative and qualitative results. To reduce the disadvantages, multiple sources and a 
synthesis of both methods.  

The  work  group  picked  the  mixed  method  approach,  because  other  methodological 
approaches are insufficient in obtaining both in depth knowledge and numerical data to 
truly capture how the SWD performs. The specific methods used are interviews, survey, 
desk research and case studies. The quality of the analysis is high due to a combination 
of triangulation, inclusion of supporting studies and other sources. 

The evaluation does contain limitations, that must be addressed. 

1.  Limited data, which is mitigated by triangulation and reinforcement of additional 

sources.  

2.  Implementation time of legislation reduces the full measurable effect.  

Stakeholder consultation strategies. The consultation strategies used primarily “call for 
evidence” and other tools. These tools are interviews (40+), targeted survey (3 to 5), focus 
groups and workshops. The timeline ranges from Q1 2024 to Q1 2025. The strategy has 
successfully  managed  to  capture  the  feedback  and  opinions  of  various  relevant 
stakeholders  in  a  good  balance.  This  means  the  evaluation  is  representative  of  how 
national authorities, industry and other civilian actors are affected by the legislation. 

The  evaluation  is  good  on  validity  and  okey  on  reliability.  In  terms  of  reliability,  the 
evaluation does contain some problems due to limited data. This has the  consequence, 
that the evaluation cannot guarantee a reproduction of the same results over multiple tests. 
To mitigate this, additional studies and desk research has been used to support the data 
we have. In terms of validity, the evaluation uses multiple indicators to truly capture the 
effects of the legislation (see annex 3). Thus, Validity is good, where mitigation measures 
are  indirectly  built  into  the  evaluation  due  to  multiple  indicators  meaning,  if  some 
indicators fail others will detect it. 

75 

 
Annex III. Evaluation matrix and, where relevant, Details on answers to the evaluation questions (by criterion) 

Effectiveness  

Evaluation 
Question 

Effectiveness 

Effi  1.1  What 
were 
the  main 
challenges  in  the 
implementing 
phase  after  April 
2021?  To  what 
extent  have  these 
been addressed? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

1.1.1  To  which 
extent  were  MS 
able to align their 
national 
legislation  with 
the 
new  EU 
legislative 
framework in due 
time?  To  which 
extent did MS opt 
for  an  alignment 
of  national  law 
with  AHL  by 
consolidating 
existing 
text 
versus  repealing 
existing text?  
1.1.2 Which were 
the 
challenges 
faced  by  MS  in 
implementing the 
its 
AHL  after 

Identification 

1.1.1 Level of alignment of 
national legislation to AHL 
across MS  
of 
1.1.2 
challenges 
the 
implementation  of  AHL  in 
Member States  
1.1.3-4  Measures  taken  at 
EU level 

in 

1.1.1  Number  of  Member 
States  that  have  fully  aligned 
their national legislation 

1.1.1  Number  of  Member 
that  have  partially 
States 
national 
aligned 
legislation 

their 

1.1.1  Number  of  Member 
States  that  have  not  aligned 
their national legislation 

1.1.1  Degree  of  significance 
of the lack of adaptation 

1.1.1  Type  of  alignment 
carried out by MS 

1.1.1  Timing  of  legislative 
adaptation 

1.1.2 Challenges identified by 
stakeholders  that  affect  the 
implementation of the AHL at 
national level 

-  MSs 

reports 

-  MSs 

reports 

- 

 MSs 
reports 

-  Audit 

reports  

-  MSs 

reports  

-  Annual 
reports 

-  Audit 
reports 

76 

the 

consolidated 

rules.  Differences 

Member States were largely able to 
align their national legislation with 
the  AHL  within 
required 
timeframe,  contributing  to  a  more 
harmonised  framework.  However, 
the  extent  and  approach  varied: 
existing 
some 
legislation into the new framework, 
while others repealed and replaced 
national 
in 
varying 
reflect 
alignment 
administrative  capacity  and  legal 
traditions.  
the 
Key 
framework, 
complexity  of 
uneven clarity of certain provisions, 
and 
limited 
and 
veterinary 
national 
differences 
interpretation. Practical issues also 
arose from gaps in digital systems, 
workforce  constraints,  and  partial 
implementation of obligations such 

administrative 
resources, 

challenges 

included 

the 

in 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

of 

from 

entry  into  force? 
(e.g.  complexity 
of 
the 
regulations;  lack 
of 
; 
clarity 
insufficient 
resources, 
resistance 
stakeholders, 
lack 
coordination)  
1.1.3 How and to 
which 
extent 
were  challenges 
addressed  at  the 
EU level?  
1.1.4 How and to 
extent 
which 
were 
those 
challenges 
addressed 
national level? 

at 

through 

The  AHL 

as biosecurity, animal health visits, 
and contingency planning. 
level,  challenges  were 
At  EU 
guidance, 
addressed 
coordination  mechanisms, 
and 
digital  tools  such  as  ADIS  and 
TRACES, 
improved 
which 
surveillance,  notification,  and  data 
exchange. 
itself 
strengthened  legal  clarity,  defined 
introduced 
responsibilities,  and 
structured  approaches  to  disease 
management, 
supporting  more 
coordinated implementation. 
At  national  level,  Member  States 
addressed 
through 
challenges 
adjustments, 
legislative 
and 
administrative  measures, 
of 
strengthening 
gradual 
implementation systems. However, 
progress  remains  uneven,  with 
continued 
in 
enforcement,  resource  allocation, 
and  system  capacity  affecting  the 
full  and  consistent  application  of 
the AHL 
External study, p. 52 

differences 

-  MSs 

reports 
-  Audit 
reports 

-  Audit 
reports 

-  Eu 

legislation 
changes 
EU 
website  

-  Audit 
reports 
-  Annual 
reports 
-  Audit 

reports  

-  Ms reports 
-  Audit 
reports 

1.1.2  Types  of  challenges 
stakeholders 
identified  by 
(uneven 
point, 
regulatory, 
administrative, 
financial,  technical,  cultural, 
etc.) 

starting 

1.1.2 The size and structure of 
MS affect the implementation 
of AHL 

1.1.3  Measures  taken  at  the 
EU level to address identified 
challenges 
of 
Implementing Acts/Delegated 
Acts)/and  the  amendments  to 
these  Acts 

(Number 

1.1.3  Timing  of  Adoption  of 
tertiary legislations 

1.1.3  Evidence  of  adequate 
and  regular  training  sessions 
organised  

1.1.3 Best practices shared 

level 

taken  at 
1.1.4  Measures 
to  address 
national 
identified  challenges 
(e.g. 
establishment  of  Task  force, 
Committee, training session) 

77 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

Effe  1.2  To  what 
the 
extent  has 
legislation 
AHL 
its 
achieved 
general 
and 
specific 
objectives? 

What 
1.2.1 
progress has been 
made towards the 
achievement  of 
general 
the 
of 
objective 
preventing 
and 
controlling 
animal  diseases 
to 
transmissible 
animals 
or 
humans by:  
ensuring 
- 
improved  animal 
health  to  support 
sustainable 
agricultural  and 
aquaculture 
production 
[Art.1(2.a.i)] 
-  ensuring 
effective 
functioning of the 
internal  market 
for  the  livestock 
and  aquaculture 
sector  and  other 

the 

of 
the 

Evidence 
towards 

1.2.1.1 
progress 
general objectives  
1.2.1.2  The  AHL 
is 
effective  in  preventing  and 
controlling animal diseases 
Stakeholder 
1.2.1.3 
the  AHL 
perception  on 
the 
to 
contribution 
achievement  of  expected 
results 
1.2.1.4 
Measurable 
improvements in the health 
status  of  animals  since  the 
implementation of AHL 
1.2.1.5  Availability  and 
training 
effectiveness  of 
focused  on 
programmes 
animal 
and 
sustainable practices 
Stability, 
1.2.1.6 
competitiveness,  growth  of 
livestock  and  aquaculture 
market  
1.2.1.7  Evidence  of  no 
significant  disruptions 
in 
the Internal market 

health 

- 

Input 
during 
PAFF  and 
other 
meetings 
by 
stakehold
ers  
-  https://foo
d.ec.europ
a.eu/anim
als/animal
-
diseases/s
urveillanc
e-
eradicatio
n-
programm
es-and-
disease-
free-
status_en#
disease-
free-areas  

-  Audit 
reports 

1.2.1.1  Stakeholder  views  on 
the reasons for (un)success in 
achieving 
general 
the 
objective 

1.2.1.1  Number  of  areas 
disease-free 
declared 
following 
the 
to 
implementation of eradication 
programmes  

1.2.1.1 Change in the number 
and  quality  of  animal  health 
veterinarians 
visits 
[Art.25] 
the 
since 
introduction of AHL  

from 

78 

tools 

through 

The AHL has made clear progress 
towards  achieving  its  general  and 
specific objectives by establishing a 
harmonised 
prevention-
and 
improving 
framework, 
oriented 
disease  control,  and  supporting 
trade 
such  as 
regionalisation  and  traceability.  It 
legal 
has  also  simplified 
framework 
a 
flexible,  risk-based  approach  to 
emerging diseases. 
However,  its  full  effectiveness  is 
not  yet  realised  due  to  uneven 
implementation, 
in 
practice,  and  the  early  stage  of 
application,  which 
a 
complete assessment of outcomes. 
External study p 60 

the 
introduced 

complexity 

limits 

and 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

animals 

kept 
[Art.1(2.a.ii)] 
- 
reducing 
adverse effects of 
animal  diseases 
on animal health, 
public health and 
the  environment 
[Art.1(2.a.iii)]?  

1.2.1.2  Appropriate  systems 
are in 
place to ensure the traceability 
of  kept  terrestrial  animals, 
aquatic  animals  and  germinal 
products  [Art.  108-123;  186-
190] 
1.2.1.2 
Appropriate 
(preventive)  measures  are 
undertaken for movements of 
kept  animals 
[Art124-169; 
191-225; 244-251] 

1.2.1.2.2-3 
availability/number 
veterinarians 
regular  visits 
suitable by stakeholders 

The 
of 
carrying  out 
is  deemed 

1.2.1.2  The 
health 
visits 
suitable by stakeholders 

frequency  of 
deemed 

is 

1.2.1.1 Number and quality of 
and 
contingency 
exercises 
simulation 
conducted [Art.43;45] 

plans 

79 

- 

 Audit 
reports 

-  Audit 

reports  

-  Audit 
reports 

-  Audit 

reports  

-  FVE 

report  on 
art. 25 

-  MS 

reports 
-  Audit 
reports 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

1.2.1.1 Union antigen, vaccine 
and  diagnostic  reagent  banks 
are  established  and  provide 
sufficient  stocks  and  supplies 
[Art.48] 

1.2.1.4  Uptake  (and  number) 
of  training  among  staff  and 
veterinarians [Art.13] 

1.2.1.5 
Strengthened 
competitiveness  of  farming 
and the rural economy (I) 

1.2.1.6 Market data (volumes, 
are 
flows) 
trade 
prices, 
maintained or increased 

80 

-  MS 

reports 
-  Audit 
reports 

- 

Interviews 

-  Desk 

research: 
Comext 
database 
and 
Eurostat 

on 

-  Focus 
groups 
(Question
s 
potential 
benefits 
for 
due 
AHL 
introducti
on) 

trade 
to 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

-  Desk 

research: 
Comext 
database 
and 
Eurostat 

1.2.1.6  Trade 
maintained and undisrupted  

flows 

are 

on 

-  Focus 
groups 
(Question
s 
potential 
benefits 
for 
due 
AHL 
introducti
on) 

trade 
to 

1.2.2  To  which 
extent  did 
the 
AHL  achieve  its 
specific objective 
of  establishing  a 
single, 
simplified, 
and 
transparent 
regulatory 
clear 
framework 
by 
providing  a  clear 
balanced 
and 
of 
distribution 

1.2.2.1  There  is  adequate 
clarity 
actors 
across 
regarding  their  roles  and 
responsibilities 
1.2.2.2  There  is  adequate 
balanced  distribution  of 
roles and responsibilities 
1.2.2.3  The  AHL  has 
simplified 
introduced 
procedures  
1.2.2.4  The 
framework 
complexity 

regulatory 
reduces 
and 

1.2.2.2.1-2 
Stakeholders’ 
views  regarding  clarity  and 
benefit  of 
role  and 
the 
responsibilities  outlined  by 
the AHL 

1.2.2.3  Stakeholder  views  on 
the new  rules and procedures 
introduced by the AHL  

1.2.2.4  Stakeholder  views  on 
the  rules  and  procedures  that 
were  already  covered  by  the 
AHL  and 
that  have  been 
updated and simplified 

-  Survey 

-  Survey 

-  Survey 

81 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

and 

roles 
responsibilities 
and 
simplified 
procedures? 

introducing 

- 

Interviews 
with 
internatio
nal 
organisati
ons 
-  Desk 

research: 
disease 
notificatio
n  systems 
and  audit 
reports 
-  Disease 

notificatio
n  systems 
and  audit 
reports 
-  Disease 

notificatio
n  systems 
and  audit 
reports 

-  Traces 

valuation  

administrative  burden  for 
stakeholders 
1.2.2.5 There is evidence of 
effective  responses  due  to 
simplified procedures 

1.2.2.4 Good governance and 
compliance with international 
standards (WOAH) (R) 

1.2.2.5  Existing  and  well-
functioning 
online 
information system to register 
and document the evolution of 
diseases [Art.22] (O) 

1.2.2.5 and 1.2.1  Number and  
of  disease  notification  within 
MS, to other MS and to the EC 
[Art 18-21] (O) 

1.2.2.5  Protocols  have  been 
developed  to  ensure  effective 
and 
emergency 
measures in cases of outbreak 
or hazard [Art. 257-262] (O) 

rapid 

1.2.2.5  Existing  and  well-
functioning 
online 
information  system  to  track 
animal movements 

82 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

1.2.4  To  which 
extent  did 
the 
AHL  achieve  its 
specific objective 
ensuring 
of 
consistency 
among  principles 
of  animal  health, 
animal  welfare 
and  food  safety 
legislation? 

1.2.5  To  which 
extent  did 
the 
AHL  achieve  its 
specific objective 
of  reducing  the 
socio-economic 
impact  of  animal 
on 
diseases 
public 
health, 
animal  welfare, 
and 
economy 

Degree 

of 
1.2.3.6 
between 
coordination 
veterinary  and  human  health 
authorities 

1.2.4.1-3 Coherence with food 
safety,  animal  welfare,  One 
Health  regulation  and  wider 
strategic policy objectives  

its 

with 

1.2.4.1  The  AHL  ensures, 
principles, 
through 
consistency 
the 
principle of animal welfare 
1.2.4.2  The  AHL  ensures, 
principles, 
through 
consistency 
the 
principle of food safety 
1.2.4.3  The  AHL  ensures, 
principles, 
through 
consistency 
the 
principle of One Health 

with 

with 

its 

its 

1.2.5.1 The social impact of 
animal diseases in terms of 
public  health  is  reduced 
thanks to the AHL 

1.2.5.2.  The  social  impact 
of  animal  disease  in  terms 
of (reduced) animal welfare 
is reduced 

1.2.5.1.1 Reduction in disease 
incidents  of  more  dangerous, 
rapidly spreading both animal 
and  zoonotic)disease  (with  a 
focus on Cat A diseases)  

1.2.5.1.4  Stakeholders'  views 
on the social impact of AHL  

1.2.5.2.1 
perception of animal health 

Improved  public 

83 

-  Surveys 
-  Findings 

from  EQ 
coherence 

Interviews 

- 
-  Case 

studies 

-  ADIS 

-  Surveys 

-  Call 

for 

Evidence 

- 

Interviews 

 
 
 
 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

society 
while 
reducing the risks 
of 
trade 
disruption? 

1.2.5.3  The 
economic 
impact of animal diseases is 
reduced  
1.2.5.4  Trade  flows  are 
improved 
the 
implementation of the AHL 

by 

Effe  1.3  How  do 
these 
results 
compare  with  the 
initial 
expectations? 

1.3.1  Has 
the 
AHL  led  to  an 
in 
improvement 
terms  of  disease 
control 
and 
prevention? 

1.3.2 How do the 
results  compare 

1.3.1  The  implementation 
of  AHL  meets  the  initial 
expectations  as  outlined  in 
the 
Impact  Assessment, 
Strategy and Legislation 
1.3.2 Stakeholders’ view on 
the implementation of AHL 
and the initial expectations 

1.2.5.2.2 Reduction of animal 
health disparities across socio-
economic groups (MS eastern 
versus western/ Farmers small 
versus bigger) 

1.2.5.2.3 Reduction of animal 
health disparities across socio-
economic groups (MS eastern 
versus western/ Farmers small 
versus bigger)  

Risks 

1..2.5.2.4 
of 
interference  with  the  internal 
market  due  to  animal  disease 
are minimised ( R) 

1.2.5.2.5  Trade 
maintained 
significant disruptions. 

flows  are 
without 

1.3.1 Number of outbreaks of 
listed disease 

1.3.1  Trade  of  live  animals 
and  animal  products  to  3rd 
countries  

1.3.2.  Stakeholders'  view  on 
results  alignment  with  initial 
expectations 

Interviews 

- 
-  Focus 
groups 

-  Case 

studies 

-  Surveys 

-  Desk 

research: 
Comext 
database 

- 

: Adis  

-  Desk 

research: 
Comext 
database 

-  Call 

for 
Evidence  

84 

The  results  of  the  AHL  broadly 
align  with  initial  expectations.  It 
has  delivered  a  flexible,  coherent, 
and 
framework, 
supporting  prevention,  improved 
coordination,  and  internal  market 
towards  a 
stability.  The  shift 
has 
proactive 

risk-based 

approach 

 
 
 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

to 
the 
expectations  set 
forth 
the 
in 
Impact 
Assessment  and 
Animal 
the 
Health  Strategy 
as 
2007-2012, 
well  as 
the 
in 
legislation? 

1.3.3  Is  the  One 
Health  principle 
reflected  in  the 
national 
legislation related 
to animal health? 

the 
1.4.1  Does 
AHL 
clearly 
outline  the  roles 
and 
responsibilities 
across  different 
actors involved in 
animal health? 

Effe 1.4  What  are 
the  strengths  and 
weaknesses of the 
AHL, in particular 
in 
to 
relation 
specific 
provisions, 
regarding: 

1.3.3    National  legislation 
the  One  Health 
reflects 
approach in their legislation 
related to animal health 

and 

strengthened  preparedness 
response capacities. 
However, implementation has been 
more  complex  than  anticipated, 
with  delays  and  inconsistencies  in 
aligning national legislation across 
Member States. 

1.3.3 
view 
Stakeholders' 
regarding  AHL  contribution 
to the one health approach  

-  Surveys 
(Q33 
coherence) 

on 

External study , p 82 

and 
Roles 
1.4.1 
responsibilities  for  actors, 
e.g.  competent  authorities 
are 
stakeholders, 
and 
clearer  and  are  defined  in 
the AHL 

1.4.2 EU priorities and their 
articulation  with  the  AHL 

1.4.1  Stakeholders'  views  on 
the  clarity  of 
roles  and 
responsibilities defined by the 
AHL 

1.4.2  Stakeholders'  views  on 
the  EU 
the  priorities  for 
intervention 
limiting 
and 
factors are clearly outlined in 
the AHL 

- 

Interviews 

-  Surveys 
(linked 
external 
coherence) 

to 

The  AHL’s  key  strengths 
roles  and 
include  clearer 
responsibilities 
across 
improved 
stakeholders, 
coordination, and a strong risk-
approach 
based 
enabling 
targeted 
intervention 
EU 
through  tools  such  as  disease 
and 
categorisation 

85 

 
 
 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

clearer 

- 
responsibilities 
-  Priorities for EU 
intervention 
- 
including 
biosecurity 
surveillance? 

prevention, 

and 

1.4.2  Is  the  link 
EU 
with 
priorities  clearly 
set in the AHL? 

1.4.3  Are  there 
any 
limiting 
factors  in  linking 
the  AHL  to  the 
EU 
wider 
priorities? 

intervention 
are 
clearly set in the AHL text 

logic 

hamper 

1.4.3  Limiting  factors  that 
the 
could 
consistency  of  the  AHL 
with wider EU priorities are 
mentioned in the AHL text 
1.4.4 Level of improvement 
of  prevention,  biosecurity 
and surveillance 

and 

Has 

1.4.4 
prevention, 
including 
biosecurity 
surveillance, 
improved  in  the 
EU 
the 
since 
adoption  of  the 
AHL?  

trade 

It 
has 
regionalisation. 
prevention, 
strengthened 
particularly 
through 
biosecurity  and  surveillance, 
the 
and  modernised 
legal 
framework, 
supporting 
measures  like  vaccination  and 
maintaining 
during 
outbreaks. 
However,  weaknesses  remain 
implementation, 
in  uneven 
stakeholder 
limited 
engagement,  and  gaps 
in 
communication.  Biosecurity 
and  prevention  measures  are 
not consistently applied across 
sectors  and  Member  States, 
with  particular  challenges  for 
In 
small-scale 
addition,  capacity  constraints 
and 
in 
risk-based 
applying 
approaches 
reduce  overall 
effectiveness. 
External study, p.83 

operators. 

expertise 

limited 

1.4.3  Stakeholders'  views  on 
the  EU 
the  priorities  for 
intervention 
limiting 
and 
factors are clearly outlined in 
the AHL 

1.4.4  Qualitative  description 
of  the  action  MS  take  to 
biosecurity, 
increase 
including 
enforcement 
measures 

1.4.4  Qualitative  description 
of  the  action  MS  take  to 
incl. 
surveillance 
increase 
enforcement measures 

1.4.4  Stakeholder  views  on 
the  overall  improvement  in 
terms  of  biosecurity  and 
prevention in the EU that can 
be attributed to the AHL 

1.4.4 Number of outbreaks of 
contagious livestock disease 

1.4.4    Number  of  training 
sessions  taken  up  by  animal 
keepers, especially farmers 

1.4.4 (Stakeholders views on) 
the reaction time 

-  Surveys 

(linked  to 
external 
coherence
) 

-  Annual 
reports 
-  Audit 

reports  

-  Annual 
reports  

-  Audit 
reports 

- 

Interviews 

-  ADIS 

-  Annual 
reports  

- 

Interviews 

86 

 
 
 
 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

Effe 1.5  What  are 
the 
main 
shortcomings  that 
be 
to 
need 
addressed? 

1.5.1  Are  there 
any shortcomings 
that 
arise 
can 
from  the  overall 
functioning of the 
AHL at EU level? 

1.5.1  Any  shortcomings  at 
EU  level  that  may  stem 
from the functioning of the 
AHL  at  EU  level  can  be 
easily identified and tackled  

1.5.2  Are  there 
shortcomings 
in 
the 
implementation 
at national level? 

1.5.2  Any  shortcomings 
that  may  stem  from  the 
implementation of the AHL 
at  national  level  can  be 
easily identified and tackled 

-  Case 

studies 

-  Case 

studies 

-  Case 

studies 

-  Case 

studies 

farmers 

Stakeholders 

for 
biosecurity 

The  main  shortcomings  relate 
insufficient  support  and 
to 
in 
guidance 
applying 
and 
disease detection measures, as 
well as uneven implementation 
of 
training  and  awareness 
programmes  across  Member 
States. 
also 
highlight  the  lack  of  adequate 
and 
funding  mechanisms 
balanced  cost-sharing  across 
the value chain as key barriers 
to  effective  prevention  and 
response. 
However, given the partial and 
ongoing implementation of the 
AHL,  it  remains  difficult  to 
structural 
fully  distinguish 
shortcomings from transitional 
implementation challenges. 
External study , p 89 

Examples 

1.5.1 
of 
shortcomings identifiable that 
can 
the 
linked 
functioning of the AHL at EU 
level  

be 

to 

1.5.1  Stakeholder  views  on 
possible  shortcomings  linked 
to  the  implementation  of  the 
AHL at EU level 

Example 

of 
1.5.1 
shortcomings 
identified  by 
MS  at  national  level  during 
contagious 
of 
outbreaks 
livestock diseases  

1.5.1  Stakeholder  views  on 
possible  shortcomings  linked 
to  the  implementation  of  the 
AHL at national level 

87 

 
 
 
Evaluation 
Question 

do 

Effe  1.6  To  what 
the 
extent 
AHL’s  risk-based 
approaches 
effectively 
prioritise 
resources 
and 
actions  based  on 
the  severity  and 
of 
likelihood 
different threats? 

Effe  1.7  Does  the 
enhance 
AHL 
transparency 
in 
decision-making 
processes  related 
to animal health? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

Idem to EQ 

1.6.1 The AHL’s risk-based 
effectively 
approaches 
and 
prioritise 
actions 
the 
based 
severity  and  likelihood  of 
different threats 

resources 
on 

AHL’s 

1.6.1  Stakeholders’  views  on 
risk-based 
the 
approaches 
effectively 
and 
prioritise 
actions  based  on  the  severity 
and  likelihood  of  different 
threats 

resources 

-  Case 

studies 

and 

The AHL’s risk-based approach is 
generally  effective  in  prioritising 
resources  and  actions,  allowing 
tailored 
proportionate 
responses  based  on  disease  risk, 
and  is  widely  supported  for  its 
scientific  basis  and  flexibility.  It 
supports  more  efficient  use  of 
resources by focusing on high-risk 
situations. 
However,  stakeholders  highlight 
the  need  for  more  flexibility  and 
more  frequent  updates  to  disease 
categorisation, 
for 
persistent  and  emerging  diseases. 
Overall 
remains 
effectiveness 
difficult  to  fully  assess  due  to 
ongoing 
uneven 
and 
implementation  across  Member 
States. 
External study p 92 

particularly 

Idem to EQ 

1.7 The AHL enhances the 
transparency  in  decision-
making processes 

1.7.1  Stakeholders  views  on 
the  transparency  in  decision-
making processes is enhanced 

-  Case 

studies 

-  Call 

for 

Evidence 

- 

Interviews 

The  AHL  has  fostered  greater 
transparency  and  openness  in 
decision-making; 
however, 
some  limitations  were  shared 
terms  of  more  deeper 
in 
involvement  of  stakeholders  . 
Extrenal study p 94 

88 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

1.8.1  The  AHL  has  an 
overall  positive  effect  on 
the  resilience  of  animal 
health systems is enhanced  

1.8.1.  Stakeholders  views  on 
the impact of the AHL on the  
resilience  of  animal  health 
systems 

Effe  1.8  Does  the 
AHL  enhance  the 
of 
resilience 
animal 
health 
systems?  

Idem to EQ 

effect  on 

1.8.2  The  AHL  has  a 
positive 
the 
competitiveness  of  the  EU 
agri-food sector in the face 
of changing environmental, 
social 
economic 
conditions  

and 

1.8.2  Stakeholder  views  on 
the impact of the AHL on the 
competitiveness  of  the  EU 
agri-food sector  

1.8.2 Data and statistics linked 
to  the  competitiveness  of  the 
EU agri-food sector 

1.8.2 Intra-EU trade and trade 
with 3rd countries 

- 

Interviews 

- 

Interviews 

-  Desk 

research: 
Comext 
database 

- 

Inputs 
from other 
EQs 
-  Desk 

research: 
Comext 
database 

Inputs 
from other 
EQs 

- 

tools  allow  for 

The  AHL  has  enhanced  the  EU's 
capacity  to  detect,  contain,  and 
through 
to  outbreaks 
respond 
structured mechanisms like zoning, 
traceability. 
regionalisation,  and 
These 
targeted 
than  blanket 
restrictions  rather 
bans,  helping  maintain 
internal 
market stability even during disease 
events.  
the 
Stakeholders  acknowledged 
AHL’s  contributions  to  resilience 
but  also  highlighted  its  limitations 
in  swiftly  addressing  emerging 
diseases, especially under changing 
climate  and  ecological  conditions. 
External study p.96 

Effe  1.9  What 
the 
were 
or 
unexpected 
unintended effects 

Idem to EQ 

1.9  Stakeholders  examples 
of 
or 
unexpected 
unintended effects that stem 

1.9 Stakeholders examples of 
unexpected  or  unintended 
effects  that  stem  from  the 
implementation of the AHL 

The unintended effects refer mainly 
to 
higher-than-expected 
administrative  effort  and  slower 
alignment of national legislation. In 

89 

 
 
 
such 

tools 

addition, 
as 
regionalisation  are  not  always 
applied  or  recognised  consistently 
between  Member  States,  reducing 
their  effectiveness  and  affecting 
confidence 
intra-EU  disease 
management. 
However,  these  effects  are  largely 
linked  to  the  ongoing  and  partial 
implementation of the AHL, which 
limits a full assessment at this stage. 
External study p.96 

in 

Evaluation 
Question 

which 
occurred 
implementation? 

have 
during 

Sub question 

Judgement criteria 

Indicators 

Data sources 

from the implementation of 
the AHL 

1.9 Stakeholders examples of 
such 
the 
occurrences 

impacts 

of 

90 

 
 
 
 
 
Efficiency 

Evaluation 
Question 

Efficiency 

Sub question 

Judgement criteria 

Indicators 

Data sources 

the  AHL 

Effi  2.1  Has  the 
implementation 
of 
generated 
incremental  costs 
and  benefits  for 
different 
stakeholders? 
costs 
Are 
proportionate 
to 
the benefits of the 
AHL? 

the 

and 

2.1.1  What  are 
the 
incremental 
costs and benefits 
for  stakeholders 
impacted  by  the 
AHL (i.e., Cas of 
MS and accessing 
countries, 
livestock 
aquaculture 
farmers,  animal 
farming 
and 
industry 
operators, 
veterinarians, and 
competent 
of 
authorities 
major 
trading 
partners)  versus 
baseline  scenario 
(pre-AHL) for all 
key activities? 

2.1.2 
incremental 

Are 

Assessment 
costs 

2.1.1. 
incremental 
benefits 
per 
stakeholder group 

of 
and 
each 

Costs 
(livestock 

2.1.1  (direct  and  indirect) 
for 
incremental 
and 
operators 
aquaculture farmers, animal 
farming 
industry 
and 
representatives):  

• 

• 

• 

• 

of 

cost 
implementing 
biosecurity 
measures 
to 
prevent and control 
disease 
costs of traceability 
systems  for  animal 
animal 
and 
products  and  for 
complying 
with 
animal movements 
of 
costs 
implementing 
emergency 
measures in case of 
outbreaks 
costs  for  training 
and education 

91 

-  Surveys 
- 
Interviews 
-  Desk research 

and 

benefits 
and 

The  AHL  has  increased  short-
term  costs  (e.g.  administration, 
training,  biosecurity,  reporting), 
are  mainly 
while 
structural 
preventive—
improved  coordination,  clearer 
better 
responsibilities, 
preparedness—and 
remain 
difficult to quantify. 
It  is  not  yet  clear  that  benefits 
outweigh  costs.  Perceptions  are 
mixed: 
industry 
farmers  and 
often  see  higher  costs,  while 
NCAs and veterinarians report a 
more 
and 
view, 
is  more  positive. 
academia 
Overall, the AHL shows potential 
for benefits to outweigh costs in 
the  medium 
term, 
to 
although  this  is  not  yet  clearly 
substantiated. 
Costs  are  unevenly  distributed, 
with  farmers  (especially  small-
scale),  NCAs,  and  veterinarians 
bearing  the  main  burden,  while 
benefits  are  broader,  long-term, 
and less tangible. 

balanced 

long 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

External study p. 98 

-  Surveys 
- 

Interviews 

-  Surveys 
- 

Interviews 

larger 
the 

benefits 
than 
incremental 
costs? 

2.1.1  (Direct  and  indirect) 
Costs for veterinarians: 

• 

• 

• 

training 

costs  of 
and education 
cost 
of 
implementing  new 
technologies 
for 
health surveillance 
costs  and  admin 
for 
burdens 
cooperation 
and 
communication 
activities 

• 

• 

for 
and 

2.1.1 Costs for NCAs: 
costs 
compliance 
reporting 
costs 
of 
harmonization  and 
coordination 
cost 
management 
case of outbreaks 

crisis 
in 

for 

• 

92 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

-  Surveys 
- 

Interviews 

-  Surveys 
- 

Interviews 

• 

2.1.1 Costs for EU officials: 
costs and resources 
for 
data 
maintenance 
regulatory 
oversight costs 

and 

• 

•  Cost for training 
•  Developing 

and 

amending 
delegated acts 

2.1.1  (Indirect) Cost for the 
public: 
• 

and 

consumer 
production costs  

93 

 
 
2.1.2  Benefits  for  operators 
(livestock  and  aquaculture 
farmers  representatives  and 
animal  farming  &  industry 
representatives (SMEs) 

2.1.2 The benefits outweigh 
costs/stakeholders 
the 
consider 
to 
the  benefits 
outweigh the costs 

• 

• 

• 

• 

• 

or 

for 

from 

benefits 
from 
clearer  rules  and 
responsibilities 
benefits 
market 
opportunities 
preventive 
measures 
equipment 
benefits 
from  a 
better image of the 
sector 
financial 
benefits of reduced 
disease instance 
financial  benefits 
of  better  health 
status in the region 
(market 
opportunities, 
competitiveness  vs 
regions  with  lower 
status) 
benefits  associated 
with the circulation 
of 
and 
animals 
trade 

-  Surveys 
- 

Interviews 

2.1.2  Benefits for NCAs: 

-  Surveys 

94 

 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

• 

• 

benefits 
from 
harmonisation  and 
coordination  
benefits 
from 
clearer  roles  and 
responsibilities 

• 

2.1.2 Benefits for the public: 
benefits 
from 
improved  human 
and animal health  

2.1.2 Cost-benefit ratio 

2.2.1  Comparative  analysis 
of  list  of  costs  and  benefits 
as  identified  in  2.1.1  (EQ 
#2.1)  versus  the  baseline 
scenario 

2.2.1  List  of  direct  and 
indirect  costs  borne  by 
stakeholders 
and 
between 
distribution 
stakeholders) - see 2.1.1.1-5 

(total 

- 

Interviews 

-  Surveys  
- 

Interviews 

-  Surveys 
- 

Interviews 

- 

Interviews 

2.2.2-3 
Stakeholders' 
perception  on  distribution 
and  magnitude  of  costs  and 
benefits as expected 

2.2.2 Qualitative description 
of  stakeholders’  perception 
of distribution 

-  Case studies 

95 

Effi 2.2 Were the 
costs and benefits 
distributed 
as 
expected  and  of 
the  magnitude 
expected?  Are 
there  significant 
differences 
between  Member 
States?   

2.2.1  Are 
the 
costs  distributed 
among 
stakeholders 
expected? 

as 

2.2.2  Were 
benefits 
distributed 
among 
stakeholders 
expected? 

the 

as 

2.2.3  What  is  the 
of 
magnitude 
incurred 
costs 
and  benefits  for 
stakeholders? 

They 

Costs  are  not  yet  distributed  as 
initially  expected,  though  this  is 
largely  perception-based  and 
AHL 
reflects 
early 
implementation. 
are 
somewhat  uneven,  with  higher 
short-term  burdens  on  some 
farmers  (especially  small-scale), 
NCAs, and veterinarians. 
Benefits  are  more  diffuse  and 
long-term, with clearer gains for 
authorities,  while  farmers  report 
limited immediate benefits. Costs 
are  immediate  and  measurable, 
whereas  benefits  are  emerging 
and harder to quantify. 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

there 

2.2.4  Are 
significant 
differences 
in 
terms of costs and 
benefits  between 
MS? 

there 

2.3.1  Are 
additional 
regulatory 
and/or 
burdens 
savings stemming 
from 
the 
implementation 
of the AHL? 

2.3.2 
What 
elements  of  the 
legislation 
generate 
administrative 
burden and/or are 
overly complex?   

2.2.4  Differences  between 
MS identified 

2.2.4  List  of  significant 
differences  between  MS  in 
terms  of  incurred  costs  and 
benefits 

-  Case studies 

Differences  between  Member 
States are significant: those with 
stronger  systems  realise  benefits 
faster,  while  others  face  greater 
challenges and delayed gains. 
External study p.115 

2.3.1 Excessive procedures / 
timelines 
2.3.1 Procedural savings due 
to better distribution of tasks 
2.3.2  Excessive  reporting 
requirements 
2.3.2  Savings  in  resources 
dedicated to communication 
due 
enhanced 
to 
transparency 

2.3.1  List  of  additional 
regulatory  burdens  and/or 
savings  identified  at  MS 
level 

-  Case studies 

Stakeholders’ 
2.3.2 
perception of admin burden 
and/or savings 

-  Case studies 

has 

complexity 

The  AHL 
generated 
additional  regulatory  burdens, 
particularly  in  the  short  term,  as 
navigate 
stakeholders  must 
multiple  new  EU  rules  and  their 
links  with  national  legislation, 
creating 
and 
administrative  work.  While  the 
AHL  provides  flexibility  and 
potential  for  simplification  and 
cost  savings  through  risk-based 
approaches,  these  opportunities 
remain underused. The constrain 
in  the  assessment  by  uneven 
implementation 
and  ongoing 
alignment  across  Member  States 
should  be  taken  into  account. 
External study ,p.119 

from 

and/or 

Effi 2.3 Are there 
additional 
regulatory 
burdens 
savings 
stemming 
the 
implementation 
of 
the  AHL? 
What elements of 
legislation 
the 
generate 
administrative 
burden and/or are 
overly complex?   

Effi 2.4 Have any 
inefficiencies 
been 
How  do 

identified? 
these 

Idem EQ 

Inefficiencies 
2.4.1 
to 
in 
identified 
challenges  identified  as  per 
EQ #1.2 

relation 

2.4.1  Stakeholder  opinions, 
or  policy  research  notes  on 
inefficiencies 
major 
(administrative, operational, 
etc.) 

- 

Interviews 

Some  inefficiencies  have  been 
identified,  mainly  in  the  early 
implementation  phase.  NCAs 
faced challenges registering new 
operators,  farmers  report  added 

96 

 
 
Sub question 

Judgement criteria 

Indicators 

Data sources 

2.4.2  Stakeholders  identify 
inefficiencies 
their 
impact 

and 

2.4.2 Stakeholder perception 
of inefficiencies 

- 

Interviews 

2.2.1 See inputs from 2.1.1 

- 

Inputs 
other EQs 

from 

Idem EQ 

2.5.1 
opportunities 
simplification 
cost/burden 
hampering effectiveness 

Available 
for 
and 
without 

2.5.1  Stakeholder  opinion 
the  opportunities  for 
on 
simplification 
and 
cost/burden reduction 

- 

Interviews 

Evaluation 
Question 

impact  different 
stakeholders? 

Effi  2.5  What 
reporting 
obligations  stem 
from 
the 
Is 
regulation? 
there potential for 
simplification 
and 
cost 
for 
reduction, 
example  through 
rationalisation, 
benefiting 
businesses 
competent 
authorities? 

and 

97 

occur 

delays 

processes, 
face 

costs  with  unclear  short-term 
in 
benefits, 
certification 
and 
veterinarians 
increased 
administrative  workload.  These 
issues are largely transitional and 
linked to uneven implementation, 
overlapping  rules,  and  differing 
starting  points  across  Member 
States. External study ,p.124 

The  AHL  introduces  extensive 
reporting  obligations  within  a 
harmonised  EU 
framework. 
Challenges  stem  mainly  from 
implementation, as overlaps with 
national  rules  create  complexity 
and administrative burden. 
potential 
There 
for 
through  better 
simplification 
alignment, 
of 
use 
greater 
and 
flexibility, 
improved 
(e.g.  TRACES, 
digitalisation 
Preventive 
interoperability). 
measures  are  considered  cost-
effective.  
External study, p.127 

is 

 
 
 
 
 
Coherence 

Evaluation 
Question 

Coherence 

Sub question 

Judgement criteria 

Indicators 

Data sources 

C  3.1  To  what 
extent 
the 
is 
legislation 
coherent  within 
itself?  Have  the 
different 
elements  of  the 
legislation 
operated  together 
to achieve all the 
objectives  of  the 
in  a 
legislation 
coherent way? 

3.1.1  To  what 
the 
extent 
different 
provisions  of  the 
AHL  have  been 
interpreted and/or 
applied  in  a  way 
that guarantees its 
key objectives are 
fully met? 
3.1.2  To  what 
extent the AHL is 
coherent with the 
and 
delegated 
implementing 
acts  adopted  so 
far? 

3.1.1 Existence of diverging 
interpretations 
and/or 
application issues regarding 
AHL provisions 

Existence 

of 
3.1.2 
or 
inconsistent 
contradictory 
provisions 
between  the  AHL  and  its 
delegated 
and 
implementing acts 

3.1.1  Number  of  diverging 
interpretations 
provisions, 
and/or  application 
issues 
regarding AHL provisions 

3.1.2 Number of inconsistent 
or  contradictory  provisions 
between  the  AHL  and  its 
delegated  and  implementing 
acts 

-  Surveys 
- 
-  Desk 

Interviews 

research: 
legislative 
texts 
case-law 

and 

Interviews 

- 
-  Desk 

research: 
legislative 
texts 
case-law 

and 

-  Call 

for 

Evidence 

98 

than 

rather 

differences 

The  AHL  demonstrates  a  high 
level of structural and conceptual 
coherence,  with  its  components 
generally  functioning  together  in 
a consistent manner to support its 
objectives. Most issues identified 
in 
stem 
from 
interpretation 
and 
implementation  across  Member 
States 
from 
shortcomings  in  the  legislation 
itself.  Overall, 
the  provisions 
have  been  applied  in  a  way  that 
supports  the  AHL’s  objectives, 
although  such  differences  affect 
the 
these 
objectives  are  fully  achieved  in 
practice. 
The  AHL  is  broadly  coherent 
with 
and 
Implementing  Acts,  forming  a 
consistent  and  integrated  legal 
framework,  while  some  targeted 
could 
technical 
further  enhance  legal  clarity  and 
operational 
effectiveness. 
External study, p.131 

clarifications 

to  which 

Delegated 

extent 

its 

 
 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

this 

C  3.2 
Is 
legislation 
with 
coherent 
other  related  EU 
of 
pieces 
legislation 
and 
policies? 

3.2.1  To  what 
extent is the AHL 
coherent 
with 
OCR? 
3.2.2  To  what 
extent is the AHL 
coherent 
with 
ABP legislation? 
3.2.3  To  what 
extent is the AHL 
coherent 
with 
animal  welfare 
legislation? 
3.2.4.  To  what 
extent is the AHL 
coherent with EU 
legislation 
regulating 
veterinary 

3.2.1-3.2.8  Existence  of 
provisions, 
diverging 
interpretations 
and/or 
application  issues  between 
the legislations considered 

3.2.8  Degree  to  which  the 
allowed  making 
AHL 
proper use of EU financing   

3.2.1-3.2.7  Number 
diverging 
interpretations 
application issues 

of 
provisions, 
and/or 

-  Surveys 
-  Desk 

research: 
- Literature 
- EC 

legislative 
documents 

- General 

Food Law 
- Case-law 

-  Call 

for 

Evidence 
-  Case Studies 

99 

The AHL is overall coherent with 
other  relevant  EU 
legislation, 
providing  a  consistent  and  risk-
based  framework  aligned  with 
food  safety,  public  health,  and 
internal  market  objectives.  It 
shows  strong  coherence  with the 
Official  Controls  Regulation, 
food  hygiene,  zoonoses,  and 
veterinary 
legislation,  while 
alignment with TSE and disease-
specific 
generally 
satisfactory. 
Coherence 
is  moderate  with 
animal welfare legislation and EU 
financing 
instruments,  where 
further  alignment  is  needed.  No 
are 
major 
identified;  remaining  issues  are 
to 
mainly  operational, 

contradictions 

linked 

rules 

is 

 
 
 
and 

medicinal 
products 
medicated feed? 
3.2.5  To  what 
extent is the AHL 
and  its  principles 
(risk-based,  new 
scientific 
knowledge) 
coherent with the 
legislation 
regulating  TSE's 
(Regulation 
(EC)nº999/2001) 
3.2.6  To  what 
extent is the AHL 
and  its  principles 
(risk  based,  new 
scientific 
knowledge) 
coherent with the 
legislation 
regulating 
foodborne 
diseases 
(Regulation  (EC) 
nº2160/2003) and 
Regulation  (EC) 
No.  853/2004  on 
the  hygiene  of 
food  of  animal 
origin  

differences 

implementation 
across Member States. 
Overall,  the  AHL  offers  a  solid 
and  largely  coherent  framework, 
with  some  scope  for  improved 
alignment in specific areas. 
External study, p.133 

3.2.8  Number  of  cases  in 
which the AHL prevented or 
the  proper  and 
hindered 
timely  earmarking  of  EU 
financing 

- 

Interviews 

100 

 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

with 
legislation 

3.2.7  To  what 
extent is the AHL 
and  its  principles 
(risk  based  and 
scientific 
new 
Knowledge) 
coherent 
other 
regulating 
specific  zoonoses 
(Directive 
nº2003/99/EC) 
3.2.8  To  what 
extent is the AHL 
coherent with the 
EU 
financing 
measures  for  the 
prevention 
and 
control  measures 
of 
animal 
diseases? 

C  3.3  To  what 
extent  has 
the 
implementation 
of the AHL put in 
place  a  coherent 
health 
animal 

3.3.1  To  what 
extent  have  the 
provisions  of  the 
AHL 
been 
interpreted and/or 
applied  in  a  way 

3.3.1 Existence of diverging 
interpretations 
provisions, 
issues 
and/or  application 
between  AHL  and  MS 
animal health measures 

3.3.2  Number  of  diverging 
interpretations 
provisions, 
and/or application issues 

-  Surveys 
- 
Interviews 
-  Desk research 

101 

The  AHL  has  established  a 
coherent  EU-level  framework, 
but  its  implementation  remains 
uneven across Member States due 
to 
systems, 
capacities,  and  starting  points. 
While  some  countries  adapted 

different 

legal 

 
 
 
Evaluation 
Question 

the  AHL 
any 

policy  within  the 
EU  and  in  the 
territory  of 
the 
Member  States? 
the 
Did 
implementation 
of 
reveal 
incoherent 
elements 
or 
internally 
externally, 
in 
particular  with 
national 
animal 
health  measures 
and systems? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

Existence 

of 
3.3.2. 
provisions, 
diverging 
interpretations 
and/or 
application  issues  between 
AHL,  other  relevant  EU 
legislation  and  MS  animal 
health measures 

usefully 

that 
complements 
animal 
policy 
legislation 
developed 
MS? 

health 
and 

by 

3.3.2  To  what 
extent 
the 
provisions  of  the 
AHL  and  other 
EU 
relevant 
legislation  have 
been 
interpreted 
and/or  applied  in 
that 
a 
usefully 
complements 
animal 
policy 
legislation 
developed 
MS? 

health 
and 

way 

by 

C  3.4  To  what 
extent  does  the 
facilitate 
AHL 

3.4.1  To  what 
the 
extent  has 
been 
AHL 

3.4.1  Degree  to  which  the 
AHL  is  perceived  as  an 
to 
effective 

instrument 

3.4.1 Stakeholders opinion 

- 

Interviews 

102 

easily, others required significant 
changes, and full coherence with 
national  frameworks  is  not  yet 
achieved. 

The AHL generally complements 
national  animal  health  policies 
and  other  EU  legislation,  but 
coherence  is  mixed  in  practice, 
with some gaps in alignment (e.g. 
TSE,  zoonoses).  Differences  in 
ongoing 
interpretation 
national 
affect 
consistency. 

adaptation 

and 

Overall, coherence is progressing 
but  not  yet  fully  realised,  as 
implementation  is  still  ongoing 
across  Member  States.  External 
study, p.135. 

The AHL is generally recognised 
as  a 
for 
addressing  global  animal  health 

framework 

strong 

 
 
 
Evaluation 
Question 

international 
collaboration  on 
animal  health  to 
global 
address 
and 
challenges 
promote 
harmonisation  of 
standards? 

C  3.5  To  what 
extent  does  the 
AHL 
promote 
cooperation  with 
relevant 
international 
organisations, the 
of 
exchange 

Sub question 

Judgement criteria 

Indicators 

Data sources 

3.4.2  Number  of  non-EU 
countries  whose  legislation 
has been/is being inspired by 
AHL 

- 

Interviews 

challenges  and  aligning  with 
international  standards,  and  is 
viewed by many stakeholders as a 
credible  model  of 
regional 
governance.  It  has  supported 
legislative 
in 
neighbouring  countries  and  in 
export-oriented  sectors  seeking 
access to the EU market. 

alignment 

3.4.3  Number 
of  SPS 
concerns about the AHL still 
open at the WTO level 

-  Desk research 
- 

Interviews 

tackle  animal  health  and 
related  challenges  beyond 
national borders 

has 

3.4.2  Degree  to  which  the 
promoted 
AHL 
harmonisation  of  animal 
health standards outside the 
EU  

3.4.3  Existence  of  SPS 
concerns about the AHL at 
the WTO level 

recognised  as  an 
effective  model 
of 
regional 
governance in the 
health 
animal 
area? 

3.4.2  To  what 
the 
extent  has 
AHL inspired the 
legislators 
of 
other 
jurisdictions 
outside the EU?  

3.4.3  To  what 
the 
extent  has 
raised 
AHL 
concerns from the 
EU’s 
trading 
partners?  

third  countries 
and 

However,  its  influence  beyond 
the  EU  remains  moderate,  as 
is 
uptake  by 
uneven 
broader 
is 
harmonisation  of  standards 
limited. While no major concerns 
from 
are 
consistently  reported,  the  AHL’s 
specific 
complexity 
requirements can pose challenges 
for external alignment. 

partners 

trading 

and 

External study, p.137 

role 

The  AHL  has  strengthened  the 
EU’s 
international 
in 
cooperation,  particularly  within 
organisations  such  as  World 
Organisation  for  Animal  Health, 
improved 
and  has  supported 
information 
on 
transboundary  animal  diseases, 

exchange 

the  AHL 

3.5.1  To  what 
extent  has 
the 
implementation 
of 
fostered 
cooperation 
relevant 
international 

in 

3.5.1  Degree  to  which  the 
AHL  effectively  promotes 
cooperation in international 
fora 
3.5.2 Degree to which up to 
date  the  AHL  has  allowed 
information 
exchange  of 

3.5.1  Stakeholder perception 
on the degree to which AHL 
promotes cooperation 

Examples 

3.5.1. 
of 
cooperation in the context of 
AHL implementation 

- 

Interviews 

- 

Interviews 

103 

 
 
Evaluation 
Question 

information  and 
joint 
response 
measures? 

C  3.6  To  what 
extent  does  the 
intervention 
comply  with  the 
‘do no significant 
harm’ principle? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

organisations 
(e.g., 
WOAH/OIE)? 
3.5.2  To  what 
the 
extent  has 
implementation 
of 
the  AHL 
catered 
the 
for 
of 
exchange 
information  and 
joint 
response 
measures  in  the 
of 
context 
relevant 
international 
organisations 
(e.g. 
WAHIS)? 

through 

3.6.1  To  what 
extent is the AHL 
coherent with the 
EU 
to 
efforts 
fight 
climate 
change? 
3.6.2    To  what 
extent is the AHL 
coherent with EU 
that 
policies 

and joint response measures 
at the international level 

including  through  systems  like 
World 
Health 
Animal 
Information System. 

fora  and 

Its contribution is mainly indirect, 
driven  by  EU  engagement  in 
trade-
international 
it 
related  objectives.  While 
and 
facilitates 
further 
information 
efforts  in  awareness-raising  and 
technical  support  could  enhance 
its  visibility  and  uptake  among 
international partners. 

cooperation 
sharing, 

- 

Interviews 

External study, p.140 

- 

- 

Interviews 
(with  NGO 
and 
science/acade
mia)  

Interviews 
(with  NGO 
and 
science/acade
mia)  

The  AHL  was  not  specifically 
designed  to  address  the  “Do  No 
Significant  Harm”  principle,  but 
overall  it  has  a  largely  neutral 
environmental  impact.  It  shows 
limited direct alignment with EU 
policies  on  climate  change, 
circular 
and 
environmental sustainability. 

economy, 

3.5.2 Number of cases where 
exchange of information and 
joint  response  measures  in 
relation 
cross-border 
threats to animal health took 
place 
the  AHL 
framework   

under 

to 

3.6.1  Evidence 
from 
stakeholders  

literature 

collected 
and 

3.6.2  Evidence 
from 
stakeholders 

literature 

collected 
and 

104 

3.6.1.  Degree  of  alignment 
  AHL  and  EU 
between 
efforts 
fight  climate 
to 
change. 
 3.6.2  Degree to which the 
AHL limits or supports the 
implementation  of  circular 
economy  approaches  and 
solutions  (food  waste  and 
efficient use of resources) 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

3.6.3    Degree  of  alignment 
between  the  objectives  of  
AHL    and  EU  policies  on 
the  prevention  of  loss  of 
biodiversity  and  protected 
habitats and species 
3.6.4  Degree  of  alignment  
between  the  objectives  of 
the AHL and EU policies on 
environmental 
pollution 
and  unsustainable  use  of 
water and marine resources  

support 
circularity? 
3.6.3  To  what 
extent is the AHL 
coherent with EU 
policies 
to 
prevent 
biodiversity 
loss 
and  conservation 
of  habitat  and 
species? 
3.6.4  To  what 
extent is the AHL 
coherent with the 
EU  policies  on 
environmental 
pollution 
unsustainable 
management  of 
water and marine 
resources? 

and 

3.6.3  Evidence 
from 
stakeholders 

literature 

collected 
and 

3.6.4  Evidence 
from 
stakeholders 

literature 

collected 
and 

- 

- 

Interviews 
(with  NGO 
and 
science/acade
mia ) 

The  AHL  contributes  positively 
to biodiversity protection through 
disease  prevention,  including  in 
wildlife. 
certain 
However, 
measures,  such  as  culling  for 
disease  control,  may  at  times 
conflict  with  conservation  and 
rewilding objectives. 

coherence 

with 
Overall, 
environmental  policies  is  partial 
and indirect, and the assessment is 
constrained 
limited 
stakeholder  feedback  on  these 
aspects. External study, p.142 

by 

Interviews 
(with  NGO 
and 
science/acade
mia) 

105 

 
 
C  3.7  To  what 
extent 
the 
is 
intervention 
coherent with the 
EU 
sustainable 
development 
goals?  How  does 
the AHL relate to 
and  contribute  to 
strategic  policy 
objectives, 
others 
among 
One 
Health, 
Green  Deal,  a 
Long-Term 
Vision  for  Rural 
Areas  and 
the 
sustainable 
competitiveness 
of  the  agri-food 
sector? 
In 
particular,  does 
AHL 
the 
strengthen 
the 
integration  of  a 
Health 
One 
that 
approach 
recognises 
the 
interconnectedne
human, 
ss 
of 
and 
animal, 

3.7.1  To  what 
extent  does 
the 
AHL  contribute 
to  the  objectives 
of  the  EU  Green 
Deal 
the 
and 
Farm-to-Fork 
Strategy? 

3.7.2  To  what 
extent  does 
the 
AHL  contribute 
to reinforcing the 
One 
Health 
approach? 

3.7.3  To  what 
extent  does 
the 
AHL  contribute 
to the Long-Term 
Vision  for  Rural 
Areas? 

3.7.4  To  what 
the 
extent  does 
AHL  contribute 
to the current and 
emerging 
EU 
policies  on  long-
term 
competitiveness 
of  the  EU  agri-
food sector? 

3.7.1  Degree  of  alignment 
between  the  objectives  of 
AHL,  EU  Green  Deal  and 
Farm-to-Fork Strategy 

3.7.2  Degree  of  alignment 
between  the  objectives  of 
AHL  and  One  Health 
approach 

3.7.3  Degree  of  alignment 
between  the  objectives  of 
AHL 
Long-Term 
and 
Vision for Rural Areas 

3.7.1-of 4 Evidence collected 
from 
and 
literature 
stakeholders,  namely  on 
social, 
and 
environmental dimensions. 

economic 

-  Surveys 
-  Desk research 
- 

Interviews 

and 

3.7.4.  Degree  of  alignment 
between  the  objectives  of 
AHL 
and 
emerging  EU  policies  on 
long-term  competitiveness 
of the EU agri-food sector 

current 

The AHL is broadly aligned with 
frameworks, 
key  EU  policy 
including the Green Deal, Farm to 
Fork  Strategy,  One  Health 
approach,  and  the  Long-Term 
It 
Vision 
supports  the  internal  market  by 
harmonising  animal  health  rules 
and 
animal 
movements,  thereby  contributing 
to the competitiveness of the EU 
agri-food sector. 

for  Rural  Areas. 

enabling 

safe 

a 

reflects 

The  AHL 
clear 
commitment  to  the  One  Health 
approach  by  integrating  animal, 
human,  and,  to  a  lesser  extent, 
health 
environmental 
its 
considerations.  However, 
and 
implementation 
practical 
cross-sectoral integration are still 
evolving. 

Stakeholder  perceptions  vary: 
civil  society  and  academia  see  a 
while 
strong 
contribution, 
veterinarians,  NCAs, 
farmers, 
and  industry  consider  it  more 
ongoing 
due 
moderate 
implementation challenges. 

to 

External study, p.143 

106 

 
Sub question 

Judgement criteria 

Indicators 

Data sources 

Evaluation 
Question 

environmental 
health? 

107 

 
 
 
 
 
Relevance 

Evaluation 
Question 

Relevance 

R  4.1  To  what 
extent is the AHL 
fit and relevant to 
and 
current 
emerging  needs 
regarding Animal 
health? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

Is 

4.1.1 
implementation 
of 
the  AHL 
harmonised  and 
streamlined 
across MSs?   
4.1.2  Are 
the 
responsibilities of 
stakeholders 
(farmers, 
veterinarians, MS 
competent 
and 
authorities, 
others)  still  up  to 
date  with  current 
needs? 

Stakeholders 
more 
a 

4.1.1 
perceive 
harmonised approach 
4.1.2  Delineation  of  roles 
and  duties  of 
relevant 
stakeholders is clear 
4.1.3  The  availability  and 
for 
offer  of 
animal 
veterinarians, 
handlers,  and 
is 
adequate 
4.1.4  Criteria  to  address 
emerging  diseases  are  in 
place 

trainings 

staff 

facilitates 

is  overall  fit  and 
The  AHL 
relevant  to  current  and  emerging 
animal  health  needs,  providing  a 
harmonised 
adaptable 
and 
framework  that  supports  disease 
trade,  and 
control, 
ensures  a 
level  playing  field 
across  Member  States.  The 
disease listing and categorisation 
is  considered  a  clear 
system 
improvement 
remains 
appropriate to current challenges. 
The  AHL  also  broadly  defines 
stakeholder  responsibilities  and 
supports  training  (e.g.  through 
BTSF), although dissemination to 
operators 
uneven, 
remains 
leading to gaps in awareness. 

and 

4.1.1 Degree of agreement of 
stakeholders  on  the  level  of 
harmonisation  

4.1.2 Degree of understanding 
and  agreement  in  roles  and 
responsibilities  of 
relevant 
stakeholders among MS 

Proportion 

of 
4.1.3 
veterinarians, animal handlers 
and staff involved with animal 
health and biosecurity 
knowledge 
acquired 
ve 
through  formal  education  or 
training 
animal 
regarding 
health, disease prevention and 
their responsibility 

-  Surveys 

-  Surveys 

- 
Interviews 
-  Case studies 
-  Desk 

research: 
FVE 
on art. 25 

reports 

108 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

4.1.3  To  what 
extent is the AHL 
fostering  training 
for  veterinarians, 
animal  handlers 
and staff involved 
with 
animal 
health? 
the 
4.1.4  Are 
criteria for listing 
of  diseases  still 
up  to  date  with 
current needs? 

R  4.2  To  what 
extent is the AHL 
able to adapt and 
adequately  reply 
evolving 
to 
and 
threats 
challenges 
in 
animal health? 

4.2.1  Are 
there 
examples  where 
AHL,  DA  or  IA 
have adopted new 
diseases 
(including 
threats 
emerging 
diseases)? 

new 
and 

Degree 

of 
the 
of 
including 

4.2.1 
responsiveness 
legislation 
in 
new animal diseases  
4.2.2 
Stakeholders/scientific 
experts  agree  with 
the 
criteria  of  categorisation 
and 
of 
prioritisation 
animal diseases  

4.1.4  Diseases  that  cannot  be 
adequately listed 

- 
Interviews 
-  Case studies 

responses 

However,  implementation  is  not 
yet 
fully  harmonised  across 
Member  States,  with  differences 
in national approaches and use of 
flexibility leading to inconsistent 
application,  as  seen  for  example 
to  vector-borne 
in 
diseases. 
limited 
In  addition, 
detail  on  key  elements  such  as 
biosecurity  and  animal  health 
visits,  as  well  as  the  lack  of 
differentiation 
between 
production systems, creates risks 
of  uneven  implementation  and 
effectiveness.  Overall,  while  the 
framework  is  fit  for  purpose,  its 
full  potential  is  not  yet  realised 
due  to  ongoing  implementation 
challenges. 
External study, p.146 

Incorporation 

of 
4.2.12 
zoonosis, 
emerging 
new 
animal  diseases  in  AHL,  DA 
or IA 

4.2.3  Number  of  large-scale 
disease  outbreaks  and  of 
animals 
to 
culled 
eradication measures 

due 

-  Focus  group: 
academia  and 
NCAs 

-  Focus  group: 
academia  and 
NCAs 

framework, 

The AHL is largely able to adapt 
to evolving animal health threats 
its  harmonised  and 
through 
flexible 
with 
appropriate disease categorisation 
and the ability to address new and 
emerging  diseases.  Systems  like 
ADIS  support  monitoring  and 
information exchange. 

109 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

Degree 

of 
4.2.3 
responsiveness of ADIS in 
including 
animal 
diseases 

new 

the 
currently 

new 
safety 
and 

4.2.2  Does 
AHL 
consistently 
cover all diseases 
(including 
zoonosis, 
food 
threats 
emerging 
diseases)? 
4.2.3  Are 
the 
animal  diseases 
and 
categorised 
prioritised 
correctly? 

Stakeholders' 
4.2.4 
opinion/proposal  on  criteria 
for 
and 
categorisation 
prioritisation 

Interviews 

- 
-  Surveys 

However, separate legislation for 
some  diseases  (e.g.  Salmonella, 
TSEs) creates fragmentation, and 
flexibility  in  certain  categories 
can  lead  to  divergent  national 
measures,  affecting  consistency 
and intra-EU trade. 
External study, p.151 

4.2.4 Examples of inadequate 
uptake  of  new  diseases  in 
ADIS 

-  Case studies 

the 
Is 
4.2.4 
Animal  Disease 
Information 
System 
adaptable 
emerging 
diseases? 

(ADIS) 
to 

4.3.1  How  well 
adapted 
the 
AHL to: 

is 

R  4.3  Are  there 
issues  that  arose 
after the adoption 
of the Regulation 

Adequacy 

of 
4.3.1 
evaluation of whether new 
contagious  animal  and 
zoonotic  diseases  need  to 

4.3.1 Adjustments of diseases 
listed in  Reg 2018/1629  

- 
Interviews 
-  Focus groups 

Some  issues  were  identified  to  
further 
require 
attention. 
Flexibility 
in  addressing  fast-
spreading  diseases  has  led  to 

110 

 
 
 
Evaluation 
Question 

would 
that 
require 
further 
attention  in  view 
of  the  objectives 
pursued? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

-  The 

animal 
health 
situation 
that 
occurred 
after 
2021? 

-  The 

effective 
function
of 
ing 

be  included  in  the  AHL, 
including DA and IA 

to 

the 
4.3.1  Adequacy  of 
AHL 
the 
support 
functioning of the internal 
market 

4.3.1  Adequacy  of 
the 
AHL to reduce the adverse 
effect  on  animal  health, 
public  health  and 
the 
environment?  

4.3.1  Reduction  of  disturbed 
transport due to  discrepancies 
or gaps in national legislation 
necessitate  EU-level 
that 
by 
action 
stakeholders 

perceived 

4.3.1  Reduction  of  adverse 
effects  on  animal  health, 
the 
public 
environment 
to  
inadequate EU legislation  

and 
due 

health 

divergent  national  approaches 
and  trade  disruptions.  While  the 
AHL worked broadly as expected 
in  crises  (e.g  bluetongue),  gaps 
uneven 
including 
remain, 
biosecurity  improvements  across 
burdensome 
sectors 
notification 
in 
urgent situations., External study 
p.156 

requirements 

and 

- 
Interviews 
-  Focus groups 

- 
Interviews 
-  Focus groups 

111 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

4.  3.2  Adequacy  of  the 
AHL  incl.  DA  and  IA  to 
implement 
new 
technological 
developments 
appeared 
introduction 

that  have 
its 

since 

the 
internal 
market? 
-  Reducti

on in the 
adverse 
effects 
on 
animal 
health, 
public 
health 
and 
environ
ment? 

the 

is 

4.3.2  How  well 
the 
adapted 
AHL 
to 
technological 
developments 
have 
that 
appeared since its 
introduction?  

of 

the 
4.3.2  Evidence 
implementation  technological 
developments, e.g. updates of 
TRACES,  data 
collection 
digitalisation, 
methods, 
detection  methods,  vaccines, 
transport 

- 

Interviews 

112 

 
 
 
EU added value 

Evaluation 
Question 

Eu added value  

EUAV  5.1  What 
has  been  the  EU 
added  value  of 
the 
AHL 
compared to what 
could  have  been 
reasonably 
achieved 
by 
Member  States 
acting alone? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

5.1.1  T  What  are 
the major benefits 
observed  due  to 
the 
implementation 
of the AHL? 

5.1.2.  What  are 
the 
observed 
and/or 
positive 
negative  impacts 
of  the  AHL  on 
animal health and 
trade?  

5.1.3  Could  the 
same results have 
been  achieved by 
animal 
national 

Identifiable 
5.1.1 
evidence 
the 
that 
AHL’s  effects  could 
have  been  achieved 
without 
EU 
intervention 

5.1.1  Stakeholder  opinion 
on  the  extent  to  which  the 
effects  of  the  AHL  could 
have been achieved without 
intervention  without 
EU 
updating of the AHL 

-  Surveys 

Observed 
5.1.2. 
positive  and  negative 
impact of AHL  

5.1.2.  Identified  positive 
and  negative  impacts  of 
AHL  

-  Surveys 

5.1.3 
Identifiable 
evidence  that  Member 
States acting alone met 
equivalent results to the 
ones of the AHL 

5.1.3  Stakeholder  opinion 
on  the  need  for  EU-level 
coordination 

-  Surveys 

and 

The AHL has clear EU added value by 
strengthening  coordination  of  animal 
disease  prevention  and  control  across 
Member  States 
establishing 
harmonised rules, particularly for major 
(List  A  and  B)  diseases.  This  has 
contributed to greater efficiency, a level 
playing  field,  and  improved  intra-EU 
trade, while supporting more consistent 
and effective responses to animal health 
risks. 

These  results  could  not  have  been 
achieved  by  Member  States  acting 
alone,  as  national  approaches  would 
likely  remain  fragmented,  leading  to 
inconsistent  measures  and  weaker 
coordination,  especially 
for  cross-
border and emerging diseases. 

113 

 
 
Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

health  measures 
and 
system 
alone? 

5.1.4  To  what 
the 
extent  has 
AHL  contributed 
to 
coordination 
for  better  animal 
disease 

Identified 
5.1.4. 
differences in measures for 
the  prevention  and  control 
of  emerging  and 
listed 
sanitary 
and 
diseases 
measures in kept terrestrial 
and aquatic animal MS  in 
EU  MS  prior 
the 
implementation of the AHL 

to 

some  variation 

the  AHL  has  enhanced 
Overall, 
alignment  and  cooperation  across  the 
EU,  although 
in 
implementation  persists,  particularly 
due to limited detail on biosecurity and 
animal  health  visits,  which  are  left  to 
national  discretion.  External  study 
p.158 

- 
Interviews  
-  Case studies 

114 

 
 
prevention 
and 
control  measures 
in EU MS?  

Would 
5.1.5. 
measures  for  the 
and 
prevention 
control 
of 
and 
emerging 
listed  diseases  in 
terrestrial 
kept 
aquatic 
and 
be 
animals 
differently 
applied in EU MS 
without AHL?  

5.1.6 
Could 
measures  for  the 
and 
prevention 
of 
control 
emerging 
and 
listed  diseases  in 
terrestrial 
kept 
aquatic 
and 
animals 
and 
sanitary measures 
in  wild  animals 
differently 
be 
applied in EU MS 
without AHL? 

EUAV  5.2  To 
what  extent  did 

5.2.1  To  what 
the 
extent  does 

of 
5.2.1 
responsiveness  of  the 

Degree 

for 

and 

5.1.5 Identified differences 
the 
in  measures 
prevention  and  control  of 
listed 
emerging 
diseases 
sanitary 
and 
measures in wild animals in 
the 
EU  MS  prior 
implementation 
the  
AHL 

to 
of 

- 
Interviews  
-  Case studies 

5.2.1 
responsiveness 

Degree 

of 

of 
the 

- 

Interviews 

overall 
strikes 
The  AHL 
proportionate  balance  between  EU-

an 

115 

 
Evaluation 
Question 

this  intervention 
strike  a  balance 
between action at 
the  EU  level  and 
national  action? 
Is 
it 
proportionate? 

Sub question 

Judgement criteria 

Indicators 

Data sources 

provide 

AHL 
sufficient 
flexibility 
adapt 
local 
circumstances?    

rules 

to 
to 

there 

5.2.2  Are 
any 
efficiency/effecti
veness  gains  of 
EU-level  action 
to 
compared 
national action? 

level  coordination  and  national  action. 
It provides a harmonised framework for 
major  diseases  (categories  A  and  B), 
ensuring  consistent  measures  across 
allowing 
Member  States,  while 
flexibility for other diseases (categories 
C–E) to adapt to local circumstances. 

This  approach  enables  efficiency  and 
effectiveness gains compared to purely 
national  action,  particularly  through 
coordinated 
improved 
responses, 
disease  control,  and  support  to  the 
internal market. However, for diseases 
where  flexibility  is  higher,  different 
national  measures 
to 
inconsistencies, suggesting that in some 
cases  stronger  EU-level  coordination 
improve  uniformity. 
further 
could 
External study p.161. 

lead 

can 

legislation  in  including 
new animal diseases 

legislation in including new 
animal diseases 

5.2.2 
Identifiable 
evidence  that  the  AHL 
ensures 
efficiency/effectiveness 
gains 
to 
national actions 

compared 

5.2.1  Stakeholder  opinion 
on  the  flexibility  provided 
by  the  AHL  to  adapt rules 
to local circumstances 

5.2.2  Identifiable  evidence 
that 
the  AHL  ensures 
efficiency/effectiveness 
gains compared to national 
actions 

5.2.2  Stakeholder  opinion 
on  efficiency/effectiveness 
gains  driven  by  the  AHL 
compared 
national 
to 
actions 

- 

Interviews 

- 

- 

from 

Inputs 
efficiency/eff
ectiveness  

from 

Inputs 
efficiency/eff
ectiveness 

116 

 
 
 
EU added value could be strengthened 
through  clearer  and  more  structured 
guidance  to  support  more  consistent 
implementation across Member States, 
sector-specific 
including 
guidance 
improve  clarity  and 
compliance. 

tailored, 

to 

Greater  sharing  of  best  practices  (e.g. 
biosecurity,  veterinary  workforce)  and 
stronger capacity in applying risk-based 
approaches  would 
further  enhance 
consistency  and  effectiveness,  while 
local 
flexibility 
maintaining 
conditions. External study p.163. 

for 

Evaluation 
Question 

Sub question 

Judgement criteria 

Indicators 

Data sources 

EUAV  5.3  What 
adaptations could 
increase 
the 
additionality  of 
EU-level action? 

Can 
5.3.1 
be 
adaptations 
identified 
that 
may  increase  the 
of 
additionality 
EU-level action? 

5.3.1  Suggestions  for 
put 
improvements 
forward 
justify 
that 
(further) 
EU-level 
action 

5.3.1 
suggestions 
improvements 
EU-level action 

Stakeholder 
for 
justifying 

-  Surveys  
- 

Inputs 
previous 
criteria  

from 

117 

 
 
Annex IV. Overview of benefits and costs  

Table 1. Overview of costs and benefits identified in the evaluation 

Citizens/Consumers  

Businesses 

Administrations 

Quantitative  

Comment 

Quantitative  

Comment 

Quantitative  Comment  

Cost or Benefit description: 

area 

1: 
Key 
and 
Prevention 
control 
of 
transmissible  animal 
diseases; 

Recurrent 
one-off: 

and 

of 
Estimation 
potential  product 
increasement of 0 
-  5% 
to  offset 
business 
additional  cost  in 
producing food. 

Direct  benefit:  Less 
risk of sickness from 
animals  and 
their 
products.  

benefit: 
of 

Indirect 
Lower 
use 
antimicrobials 
contributing  to  less 
AMR 

Indirect 
Cost: 
Potentially  a  slight 
increase in pricing of 
goods. 

Direct benefit: 

Less 
administrative 
work from 

disease 
incidents due to 

less 
duplications. 

National 
authorities 
an 
estimate 
in 
increase 
burden 
10% 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 
less 
administrative 
for 
works 
incidence. 

and 

are 
Estimates 
that  benefits  of 
healthy  animals 
far outweigh the 
economic 
impact. 
For 
example, 
an 
average 
pig 
earns 
farmer 
5.753.700  euro 
per  year,  who 
can  face  losing 
profits 
depending 
infected 
animals.  Profit 
loses from death 
animals 
of 
profits: 
affect 
from 
ranging 
dead 
10% 

on 

Direct  benefit: 
Less 
of 
risk 
diseases 
destroying  farms. 

Indirect  benefit: 
Less 
farms 
destroyed,  more 
on 
products 
market 
giving 
macroeconomic 
benefits. 
Additionally, less 
environmental 
impacts 
for 
farmers  if  other 
farms get sick. 

Direct 
compliance cost: 
to 
Adjustment 

<Written by> 

<Month – 20XX> 

 
 
  
new 
requirements. 
Estimate 
adjustment 
10%. 

slight 
5-

Enforcement 
cost: 
Inspection 
of  animals  health 
still 
are 
happening, 
no 
cost change here. 

animals 
(575.370  euro) 
to 
90% 
(5.178.330 
euro) dead ones. 
Animal  deaths 
are 
unpredictable, 
but 
animals 
outreach 
administrative 
burdens 
farmers, 
disease 
outbreaks  cause 
financial ruin.  

of 
far 

on 
as 

loss 

area 

2: 
Key 
and 
Prioritisation 
categorisation 
of 
animal  diseases  of 
Union concern 

Recurrent: 

Not applicable 

an 

Farmers 
indicate 
additional 
burden  on  5  to 
10% 
extra, 
on 
depending 
their  size.  This 
is 
by 
offset 
quicker 
identification  of 
animal  diseases 
that  lowers  risk 
further 
of 

Direct  benefit: 
Proportionate 
measures 
to 
prevent 
and 
control 
animal 
avoid 
diseases, 
focussing  on  too 
many 
diseases 
Indirect  benefit:  
Common 
knowledge 
diseases 
regions 

on 
in 
aids 

National 
authorities 
an 
estimate 
in 
increase 
10% 
burden 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 

and 

Direct  benefit: 
Easier 
administrative 
work 
identification 

on 

Enforcement 
cost: 
Monitoring  and 
the 
updating 
list.  No  cost 
change  due  to 

119 

 
  
Key  area  3:  Animal 
disease  Surveillance, 
detection, 
early 
notification, 
and 
laboratory 
confirmation; 
eradication 
programmes 
disease–free status.  

and 

Recurrent 
one off: 

and 

Direct 
benefit: 
Consumer  knowing 
is  disease-
product 
free. 

Indirect benefit: Not 
becoming 
infected 
from other people. 

animal 
and infections. 

deaths 

and 
better 
focussed  earlier 
treatment.  

– 

Estimation  of  a 
5 
10% 
increase, 
depending 
on 
the  size  of  the 
farmer.    This  is 
by 
offset 
quicker 
identification  of 
animal  diseases 
that  lowers  risk 
further 
of 
animal 
deaths 
and infections. 

Indirect  benefit: 
Label  of  “disease 
is 
free” 
marketable. 

status 

cost: 

Direct 
Implementation 
fees (one off). 

Enforcement 
cost: 
Surveillance, 
testing, 
disease 
control measures  

their 
part  of 
agencies work. 

Direct benefit:  

Direct 
cost: 
Implementation 
fees (one off). 

Enforcement 
cost:  Reaction 
to  notification, 
and 
laboratory 
confirmation  of 
diseases. 

less 
administrative 
works 
for 
incidence. 

National 
authorities 
an 
estimate 
in 
increase 
10% 
burden 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
healthier 
as 
population, 
animals 
less 
administrative 
works 
for 
incidence. 

and 

120 

 
  
 
 
area 

4: 
Key 
and 
Biosecurity 
of 
responsibilities 
operators 
and 
competent authorities 

Recurrent: 

Key  area  5:  Disease 
eradication, 
awareness, 
preparedness 
control 

and 

Recurrent: 

Not applicable 

an 

Farmers 
indicate 
additional 
burden  on  5  to 
extra, 
10% 
depending 
on 
their  size  from 
small  to  large. 
This is offset by 
actions 
to 
minimize 
introduction  of 
harmful 
organism. 

Indirect  benefit: 
Prevention 
of 
introducing 
harmful organism 
reduces  risk  of 
disease 
outbreaks. 

Enforcement 
cost:  Actions  to 
minimize  risk  of 
introduction 
of 
harmful 
organisms. 

National 
authorities 
an 
estimate 
in 
increase 
burden 
10% 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 
less 
administrative 
for 
works 
incidence. 

and 

Indirect 
benefit: 
Awareness 
allows 
to  make 
consumer 
better  choices  when 
buying products. 

121 

Direct  benefit: 
Better 
farmer’s 
awareness,  easier 
knowledge 
of 
animal  diseases 
severity. 

Indirect  benefit: 
Disease 
eradication 
can 
long  term  lead  to 

National 
authorities 
an 
estimate 
in 
increase 
10% 
burden 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
healthier 
as 

of 

Indirect 
benefit: 
Prevention 
introducing 
harmful 
organism 
reduces 
enforcement 
cost 
less 
notifications 
and 
checks. 

through 

laboratory 

Enforcement 
cost:    Actions 
to minimize risk 
of  introduction 
of 
harmful 
organisms. 

Indirect 
benefit: 
Disease 
eradication  can 
long  term  lead 
to 
better 
competitiveness 
on 
a 
macroeconomic 
scale. 

 
  
  
  
6: 

area 
Key 
Identification, 
and 
traceability, 
movements 
of 
animals and germinal 
products 

Recurrent: 

Bigger 

Enforcement 
cost: 
administrative 
burden  due  to 
and 
new 
lengthier tasks. 

and 

population, 
animals 
less 
administrative 
for 
works 
incidence. 

National 
authorities 
an 
estimate 
in 
increase 
burden 
10% 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 
less 
administrative 
works 
for 
incidence. 

and 

usage 
less 
certain drugs. 

of 

Direct  benefit: 
ensured 
traceability 
of 
animals  less  risk 
diseases 
of 
destroying  farms. 

Indirect  benefit: 
Ensuring  trust  in 
national 
and 
international 
trade 

Direct 
compliance cost: 
Adjustment 
to 
new 
requirements.  

Enforcement 
Inspection 
cost: 
of  animals  health 
still 
are 

benefit: 
Indirect 
trust  of 
Ensuring 
consumers 
when 
buying  products  and 
from 
animals 
thrustful sources.  

122 

 
  
  
  
area 

Key 
Registration 
approval 
establishments 
operators.  

7: 
and 
of 
and 

One off: 

benefit: 
Indirect 
trust  of 
Ensuring 
consumers 
when 
buying  products  and 
from 
animals 
thrustful sources 

Farmers  expect 
longer 
slightly 
registration  and 
approval. 

no 
happening, 
cost change here. 

Indirect  benefit: 
Ensuring  trust  in 
national 
and 
international 
trade 

cost: 
to 
takes  a 

Direct 
Applying 
register 
little time.   

Enforcement 
cost:  Approval 
of 
operators, 
though  already 
a  part  of  their 
work. 

National 
authorities 
an 
estimate 
in 
increase 
burden 
10% 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 
less 
administrative 
works 
for 
incidence. 

and 

123 

 
  
 
 
Key  area  8:  Animal 
health 
requirements 
for movements in the 
Union  of 
terrestrial 
and aquatic animals. 

One-off / 
Recurrent: 

Indirect  benefit: 
health 
Better 
requirement  and 
proof  of  entry 
means 
less 
diseases spread to 
house  pets  or 
hobby farmers. 

Key  area  9:  Animal 
health 
requirements 
for  entry  conditions 
for  into  the  Union  of 
germinal 
animals, 
products 
and 
products 
 of  animal 
origin  into  the  Union 
and the export of such 
consignments 
from 
the Union. 

One-off / 
Recurrent 

Not applicable 

Farmers  expect 
requirements  to 
move  increases 
burdens  for  10-
15% of the cost. 

cost: 
Direct 
Filling  out  forms 
to 
meet 
requirement takes 
a little time. 

Enforcement 
cost:  National 
authorities have 
to 
check 
applications 
and judge them. 

National 
authorities 
an 
estimate 
in 
increase 
burden 
10% 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 
less 
administrative 
for 
works 
incidence. 

and 

Farmers  who 
follow 
already 
requirements 
expects 
no 
additional costs.  

Direct  benefit: 
your 
Knowing 
animal  is  healthy 
reduces  risk  of 
selling  unhealthy 
products. 

Indirect  benefit: 
level 
equal 
ground 
playing 
between 
intra 
Union 
requirements  for 
animals  and  their 

National 
authorities 
an 
estimate 
in 
increase 
10% 
burden 
(on all total key 
areas).  This  is 
offset  due 
to 
indirect 
the 
such 
benefits 
as 
healthier 
population, 
animals 

and 

Indirect 
benefit: 
Checking 
animals  health 
increase 
environmental, 
social  and  has 
wider economic 
impact on EU. 

Enforcement 
cost: 
Continuous cost 
check 
to 

124 

 
  
  
requirement  for 
of 
conditions 
entry 
for 
animals. 
Nothing 
so 
no 
change. 

new, 
cost 

and 
products 
those 
imported 
from  outside  the 
Union  

less 
administrative 
works 
for 
incidence. 

cost: 

Direct 
Showcasing 
requirements  for 
entry  takes  little 
time.  Takes  no 
time, if papers are 
done previously. 

125 

 
 
Annex V. Stakeholder consultation - Synopsis report 

This  annex  summarises  all  stakeholder  consultation  activities  carried  out  for  the 
evaluation of Regulation (EU) 2016/429 (the Animal Health Law – AHL). It builds on 
evidence  collected  through  the  supporting  study  (RfS  SANTE/2024/G2/007)  and 
complements the analysis presented in Section 4 of the Staff Working Document.  

1.  Consultation strategy 

1.1  Objectives of the consultation  

The stakeholder consultation was designed as a central component of the evaluation of 
the  Animal  Health  Law  (AHL),  supporting  the  collection  of  evidence  on  the  law’s 
implementation and performance across the EU. It aimed to gather insights from a wide 
range  of  stakeholders  directly  affected  by  the  AHL,  including  National  Competent 
(NCAs), farmers and industry representatives, veterinarians, civil society, academia and 
other  organisations  and  citizens.  The  consultation  complemented  the  desk  research  by 
ensuring  that  practical  experiences,  challenges,  and  stakeholder  recommendations 
informed the  assessment of the  AHL’s  effectiveness,  efficiency, relevance, coherence, 
and EU-added value. 

The first activity conducted was the Call for Evidence (CfE), gathering feedback from 
citizens and organisations from 6 March to 3 April 2024. Four online targeted surveys 
were  then  conducted  between  October  and  November  2024,  targeting  National 
Competent  Authorities  (NCAs),  livestock  and  aquaculture  farmers  and  industry 
representatives, veterinary associations, civil society, academia, and other organisations 
involved in animal health. Consequently, 40 targeted interviews were conducted from 
November 2024 to January 2025 to complement the information received. They targeted 
national and EU-level stakeholder representatives to provide a comprehensive overview 
of the AHL across the EU. In addition, five focus groups were held between December 
2024  and  January  2025  with  participants  from  selected  Member  States,  focusing  on 
national  implementation  practices  and  cross-border  movement  issues.  Finally,  two 
validation workshops were organised in February 2025 to discuss preliminary findings 
and gather feedback on the evaluation’s draft conclusions. One workshop was held online 
with  NCAs  and  the  other  in  person  with  a  broader  group  of  stakeholders  including 
farmers,  industry,  veterinarian  representatives  as  well  as  international  and  EU 
organisations/agencies.  

The consultations have achieved broad representation across EU Member States, non-EU 
the  five  consultation  activities, 
countries,  and  EU-level  organisations.  Across 
contributions  were  received  from  stakeholders  in  all  EU  Member  States,  ensuring 
comprehensive geographical coverage. Figure 1 provides an overview of the participation 
of EU Member States and several non-EU countries in the five stakeholder consultation 
activities.  

126 

      
Figure 1 – Country representation across the 5 stakeholder consultation activities 

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Non-
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CfEe

Survey

Interviews

Focus Groups

Validation Workshops

Source:  External study. 

Table 1 provides an overview of the final outreach achieved per stakeholder consultation 
activity 

127 

      
 
 
 
 
Table 1 – Overview of the stakeholder consultation activities performed and final outreach (68) 

NCAs 
(including 
CVOs) 

Farmers rep. 

Industry 
rep. 

Veterinarians 

NGOs,  Research 
academia, others 

organisations 

and 

International 
organisation (IO) 
and EU agency 

Citizens 

Call for Evidence 

18 NCAs 

26 business associations 

37 NGOs 

- 

10 businesses 

3 Research organisations/ Academia 

428 
citizens 

EU 

non-EU 

1 
citizen 

Targeted  surveys 
(4) 

23 NCAs 

16 

19 

14 

Targeted 
interviews (40) 

21 NCAs 

5 

Focus groups (5) 

6 NCAs 

 Validation 
workshops (2) 

48 NCAs 

4 

4 

4 

8 

5 

3 

8 

1 

50  Other  (hobbyists,  consumer  org.,  trade 
union) 

11 NGOs 

2 Trade Union 

1 Research organisation / Academia 

4 Other 

2 NGOs 

2 Research organisation / Academia 

International 

1 
organisation 

- 

International 

2 
organisation 

- 

1 EU agency 

4 Research organisations/ Academia 

- 

- 

International 

1 
organization 

1 EU agency 

- 

- 

(68)   The numbers of responses indicated in this table include the valid responses received. More information on the number of responses excluded (campaigns and duplicates) 

is presented in the following Section. 

128 

      
 
 
 
 
1.2 Methodology  

This evaluation follows a mixed-method approach, combining desk research with several 
consultation  activities  to  gather  quantitative  and  qualitative  evidence.  The  CfE  was 
conducted  through  the  European  Commission’s  Have  Your  Say  portal,  to  collect  open 
feedback  and  documentary  evidence  from  citizens  and  stakeholders,  which  required  a 
specific approach when handling responses.  

Identification of duplicates and campaigns, and specific approach to analyse the 
CfE’s inputs 

All  consultation  inputs  were  systematically  analysed  and  cleaned  to  ensure  unique 
responses.  The  CfE  required  some  thorough  checks  throughout  the  responses 
submitted. While 942 responses were initially submitted for the CfE, 369 responses 
were  excluded  from  the  analysis  as  they  were  identified  as  either  duplicates  (61 
responses) or part of an organised campaign (308 responses). In line with the Better 
Regulation Toolbox, these answers were separated from the analysis when submitted 
by the same respondent (duplicates) or when their content was substantially the same 
across more than 10 responses.  

Three distinct campaigns were identified among the responses and excluded from the 
final analysis (69). The first campaign was conducted by a bird breeding association and 
gathered 17 responses. The second was published by two Federations of Associations 
for  the  protection  of  nature  and  animals  and  gathered  191  responses.  The  third 
campaign was published by two hobbyists organisations and gathered 100 responses. 
All  three  campaigns,  while  providing  distinct  instructions  on  the  organisations’ 
respective websites, raised as a main concern the high costs and excessive bureaucracy 
associated with TRACES certificates for hobbyists. 

After cleaning the responses, 573 valid responses remained for the analysis of the CfE. 
All  valid  replies  were  then  scanned  through  automated  tools  and  contributions 
categorised across themes relevant to the AHL intervention logic. A coding system was 
developed to capture the main themes discussed and structure the inputs provided by 
respondents. As some responses addressed multiple issues, they contributed to one or 
more themes, allowing for a quantification of the number of respondents expressing 
views on specific topics. 

Targeted  surveys  were  designed  as  the  second  consultation  activity  to  collect 
stakeholders’ views and inputs for evaluating the AHL. They were carried out via the EU 
Survey platform and designed to collect structured input from key stakeholder groups. 
Four specific questionnaires tailored to the different stakeholder groups were shared to 
collect quantitative and qualitative inputs. The survey’s responses were extracted, cleaned 
and  analysed  to  identify  general  trends  and  quantify  the  proportion  of  respondents 
expressing  specific  views.  Closed-ended  questions  enabled  statistical  analysis,  while 
open-ended responses were examined to capture additional qualitative insights.  

(69)   A dedicated paragraph on their contribution is included in Annex 1 of the Summary Report for the 

Call for Evidence. 

129 

      
 
The interviews and focus groups were designed to address data gaps and explore specific 
challenges, experiences, and bottlenecks identified by stakeholders in greater depth. Both 
interviews  and  focus  groups  collected  qualitative  insights  on  the  implementation, 
enforcement,  and  reporting  of  the  AHL  and  potential  challenges  encountered.  All 
discussions were transcribed and carefully reviewed to identify common challenges and 
perspectives shared across stakeholder groups.  

Finally, two validation workshops were organised to discuss the preliminary findings of 
the evaluation; one was held online with NCAs and the other in person with other relevant 
EU  stakeholder  representatives.  These  activities  provided  additional  insights  and 
contributed to the triangulation and validation of findings for the evaluation. 

2.  Results of the consultation activities 

2.1 Effectiveness 

Risk-based approach 

The AHL's shift to a risk-based approach was overall praised by NCAs, allowing for more 
focused disease prevention and control measures to address animal diseases (validation 
workshop, interviews, CfE). NCAs indicated that this approach enabled better resource 
prioritisation for higher-risk areas, improving strategic decision-making and preparedness 
(surveys). Several NCAs also noted that increased transparency in rules and procedures 
has supported more open decision-making and built trust among stakeholders (validation 
workshop).  However,  a  few  NCAs  pointed  out  limitations  in  applying  the  risk-based 
approach,  noting  the  need  for  greater  flexibility  to  adapt  measures  to  local  contexts, 
especially during outbreaks of diseases categorised as C, D or E (validation workshop, 
interviews). 

Farmers  and  industry  representatives  also  recognised  the  value  of  the  risk-based 
framework  for  implementing  biosecurity  measures,  but  stressed  the  need  for  sector-
specific guidance to help implement it at the farm level. Several farmers argued that the 
current framework does not account for the diversity of production systems, with varying 
biosecurity  requirements  across  intensive,  extensive,  and  organic  farms  (interviews). 
They called for more tailored risk-based measures that reflect these differences and are 
manageable for smaller farmers (validation workshop). 

Industry stakeholders highlighted the importance of their early involvement in risk-based 
planning, especially regarding vaccine development and outbreak preparedness. Several 
of  them  also  expressed  the  importance  of  EFSA's  early  involvement  in  monitoring 
emerging diseases and the pharmaceutical industry's involvement in developing vaccines. 
Some noted that the industry was often engaged too late in the process, calling for earlier 
dialogue  between  EU  agencies  and  industry  to  ensure  timely  information  sharing 
(validation workshop). 

Veterinarians supported the risk-based approach but reported challenges such as uneven 
application in different sectors and Member States, training gaps, and unclear operational 
procedures, which limit the AHL’s effectiveness (interviews). A few veterinarians also 
highlighted that inadequate training and a lack of communication between veterinarians, 

130 

      
farmers, and authorities in some regions further exacerbated inefficiencies in managing 
animal health and preventing disease outbreaks (focus groups). 

While civil  society and research organisations also  supported the focus on prevention, 
they emphasised the need to include animal welfare in the risk-based model to ensure it 
does not prioritise economic or health risks over animal well-being (interviews). They 
called  for  broader  stakeholder  involvement  in  risk  assessment  processes  to  improve 
transparency (surveys, interviews). 

Categorisation system for diseases 

NCAs generally supported the AHL's disease categorisation system for enhancing disease 
management and early detection (CfE, validation workshop, interviews). Several NCAs 
noted  that  the  system  has  helped  prioritise  diseases  based  on  their  risk  and  impact, 
enabling  more  targeted  surveillance  and  control  (surveys).  However,  some  NCAs 
suggested that the system should be made more dynamic, allowing quicker adaptations 
based on changing epidemiological situations (validation workshop). A few NCAs also 
noted that the flexibility provided to Member States in managing certain animal diseases 
listed under categories C, D and E can lead to inconsistencies in disease control measures 
across  the  EU,  which  in  turn  can  create  disruptions  to  intra-EU  trade  (validation 
workshop, interviews). 

Farmers  expressed  mixed  views.  While  some  acknowledged  the  usefulness  of  the 
categorisation, others found it challenging to apply. They noted operators would benefit 
from  more prescriptive  guidance in  specific disease situations, rather than interpreting 
broad categories of legislative measures (surveys, validation workshop).  

Industry  stakeholders  supported  the  categorisation  but  stressed  the  need  for  greater 
flexibility,  especially  for  emerging  and  vector-borne  diseases.  They  called  for  clearer 
guidance on how responsibilities should be shared between operators and authorities in 
managing these risks (validation workshop). 

Veterinarians generally agreed that categorisation supports better planning but noted that 
its impact is limited if not accompanied by clear, harmonised procedures and adequate 
training (surveys, interviews). They also highlighted that discrepancies in categorisation 
between diseases with different transmission patterns (e.g., vector-borne versus infectious 
diseases) create operational challenges (surveys). 

Civil  society  and  research  organisations  supported  the  categorisation  system  for 
harmonising disease management across the EU (CfE). However, they called for regular 
reviews to ensure its relevance to emerging diseases (interviews, surveys). 

Roles and responsibilities of stakeholders 

A  large  majority  of  NCAs  reported  that  the  AHL  has  clarified  the  roles  and 
responsibilities  of  stakeholders  involved  in  animal  health  (surveys,  interviews,  CfE). 
Many noted that the roles of competent authorities and operators are now more clearly 
defined  than  in  previous  frameworks  (interviews).  However,  a  few  considered  that 
farmers  in  their  Member  States  are  not  sufficiently  involved  and  could  take  more 
responsibility from NCAs to ensure greater accountability. In contrast, a few NCAs point 
out  that  in  their  Member  States,  farmers  already  have  greater  responsibility  for 

131 

      
maintaining biosecurity and preventing disease outbreaks, which is viewed as a positive 
change (interviews, validation workshop). 

Farmers acknowledged the clearer definition of responsibilities under the AHL but noted 
that, in practice, their level of responsibility has not changed significantly compared to 
the previous system (interviews). Some also highlighted the need for continuous dialogue 
with competent authorities and veterinarians to ensure responsibilities are understood and 
implemented effectively at the farm level (validation workshop). 

Industry representatives generally agreed on the clearer allocation of roles (interviews, 
surveys).  However,  they  emphasised  the  importance  of  strong  collaboration  between 
authorities  and  operators.  They  suggested  that  involving  industry  more  in  decision-
making,  particularly  on  disease  control  measures  and  biosecurity  standards,  could 
improve implementation and make responsibilities more realistic (interviews). 

Veterinarians provided mixed feedback. Some noted improvements in role clarity, while 
others  pointed  to  limited  changes  in  practice  due  to  varying  structures  of  veterinary 
services across Member States (interviews). A few veterinarians highlighted that unclear 
responsibilities in  some countries lead to  gaps in health visits  and diseases prevention 
(focus groups). 

Civil society and research organisations recognised the clearer distribution of roles (CfE) 
but called for more involvement of additional stakeholders, such as NGOs and animal 
welfare specialists, especially in emergency responses and control measures (interviews). 
Including a broader range of expertise could balance disease control with broader animal 
welfare considerations. 

Implementation and challenges 

Overall, NCAs reported that the legal framework provided by the AHL has made it easier 
for  authorities  to  manage  outbreaks  and  enforce  disease  control  measures,  leading  to 
faster, more coordinated responses (interviews). However, many NCAs also highlighted 
significant  challenges  linked  to  the  complexity  of  the  legislative  framework  (surveys, 
interviews, focus groups). In particular, several NCAs underlined that the large number 
of delegated and implementing acts, combined with the length and technical detail of the 
legislation, make it difficult for authorities and stakeholders to navigate, interpret, and 
apply the rules effectively (CfE, interviews, focus groups, validation workshop, surveys). 
It  was  noted  that  the  complexity  stems  from  the  structure  of  the  AHL,  where  specific 
provisions are scattered across delegated and implementing acts, making the legislation 
harder  to  read  and  understand  (surveys).  Additionally,  a  few  NCAs  pointed  out 
difficulties in aligning the AHL with existing national legislation, with some countries 
having to invest additional time and resources while others have integrated the AHL more 
smoothly (interviews, focus groups). 

Farmers' representatives reported positive changes in disease management practices and 
improved biosecurity efforts (surveys, interviews). However, they echoed concerns about 
the  AHL's  complexity.  A  few  indicated  that  the  transition  from  a  disease-based 
organisation  to  a  topic-based  structure  has  made  the  framework  more  complicated, 
creating difficulties in understanding and applying the provisions in practice (validation 
workshop). 

132 

      
Industry stakeholders also expressed concerns about  implementation,  pointing out  that 
differences  in  the  pace  and  approach  across  Member  States  have  led  to  inconsistent 
application of the rules.  This  creates trade barriers and distorts competition  within the 
internal  market,  particularly  concerning  disease  status  recognition  and  certification 
procedures (interviews, focus groups). 

Veterinarians observed that the AHL has led to more effective disease control efforts but 
pointed  to  gaps  in  harmonisation  across  Member  States,  particularly  regarding  the 
organisation of veterinary services and the enforcement of health visits (interviews, focus 
groups). A few veterinarians also highlighted insufficient training and guidance for field-
level  professionals,  which  limits  the  effective  application  of  biosecurity  measures  and 
other preventive actions (interviews). Additionally, a few veterinarians noted that limited 
awareness of the AHL among pet owners, a lack of input from field practitioners, and 
insufficient 
the  practical 
implementation of the law (surveys). 

integration  of  research 

further  complicate 

findings 

Civil  society,  research  organisations,  and  other  stakeholders  acknowledged  the 
improvements  brought  by  the  AHL  but  stressed  that  gaps  in  implementation  remain, 
particularly  in  cross-border  cooperation  and  harmonisation  of  enforcement  practices. 
They also pointed to a need for stronger enforcement and oversight to ensure that the law 
is applied consistently across the EU (interviews, CfE). Additionally, they suggested that 
establishing dedicated forums for stakeholder engagement and better integrating cross-
disciplinary  research  into  practice  could  help  address  these  implementation  gaps  and 
support more effective application of the AHL (surveys). 

2.2.   Efficiency 

Benefits  

The  AHL  was  perceived  by  NCAs  as  instrumental  in  improving  animal  health 
management  across  the  EU.  Most  NCAs  acknowledged  the  benefits  of  the  AHL’s 
harmonised  approach,  which  has  enhanced  coordination  and  communication  between 
Member States. According to them, the AHL has made it easier to respond to cross-border 
disease outbreaks and has ensured that disease control measures are consistently applied 
across the EU (surveys, interviews).  

Several farmers and industry representatives largely agreed that the AHL has improved 
disease control and market stability. According to them, the AHL has helped ensure the 
smooth functioning of the internal market by setting clear expectations for animal health 
standards and biosecurity measures, therefore reducing barriers to trade and protecting 
public health. Some industry stakeholders saw the harmonisation of health standards as a 
key benefit of the law, as it facilitates safe trade and ensures consistency across the EU 
(interviews, surveys). 

Veterinarians  acknowledged  the  positive  impacts  of  the  AHL,  such  as  clearer 
responsibilities, improved early detection, and better disease prevention measures, which 
contributed to reducing outbreaks and economic losses on farms. (surveys, interviews). 

Civil society and research organisations recognised that the AHL has had positive effects 
on the public's trust in food safety and animal health practices. The law is seen as a step 

133 

      
towards  greater  transparency  and  accountability  in  how  diseases  are  managed, 
contributing to the EU's overall public health goals (interviews). 

Regarding  the  proportionality  between  the  costs  and  benefits  of  the  AHL,  many 
stakeholders  considered  the  benefits  to  be  proportionate  to  the  costs  involved.  A 
significant number of respondents - particularly among NCAs, veterinarians, civil society 
organisations, and other relevant organisations - considered that the benefits of the AHL 
clearly outweigh the costs or are at least proportionate. Conversely, a smaller group of 
stakeholders, mainly from the livestock and aquaculture sectors, raised concerns that the 
costs of compliance and administrative requirements may outweigh the benefits. These 
findings are reflected in the survey results presented in Figure 2.  

Figure 2 – To what extent do you consider the overall costs of the AHL proportionate 
to the benefits? 

National Competent Authorities

2

4

3

Livestock & aquaculture farmers and industry
representatives

3

1

7

16

3

5

Veterinary associations

1

5

2

Civil society, academia and other organisations
involved with animal health

2

10

3

2

3

4

1

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Benefits outweigh by far the costs
Costs are proportionate to the benefits
Costs outweigh by far the benefits

Benefits outweigh the costs
Costs outweigh the benefits
I do not know

N=77 (70) 

Source: External study. 

Costs 

While the benefits of the AHL were widely acknowledged, stakeholders noted that it has 
introduced certain costs. Some NCAs reported that the costs of implementing the law, 
including staff recruitment, training, and IT infrastructure, have placed a financial burden 
on public authorities (interviews, focus groups). A few NCAs also noted additional costs 
and  time  required  to  adapt  and  harmonise  national  standards  to  comply  with  EU 
requirements (survey, interviews). 

Farmers  and  industry  representatives  expressed  concerns  about  compliance  costs, 
especially  regarding  biosecurity  measures,  health  checks,  and  certification  processes. 
While they recognised that these costs are necessary for preventing disease outbreaks, 
many  indicated  that  they  disproportionately  impact  smaller  farms,  which  lack  the 
financial  capacity  to  meet  the  regulatory  requirements  (interviews,  surveys).  A  few 

(70)   Survey responses.  

134 

      
 
 
farmers  also  mentioned  that  the  costs  of  complying  with  certain  provisions,  such  as 
implementing animal  health surveillance programmes, have not  always  been offset  by 
tangible health benefits, especially in sectors that do not face high disease risks (validation 
workshop). 

Veterinarians  indicated  that  the  costs  of  training  and  the  additional  time  spent  on 
administrative tasks (such as health certifications and disease reporting) have added to 
their  workload.  While  these  activities  are  essential  for  maintaining  the  law’s 
effectiveness, they argued that these additional responsibilities take time away from their 
core activities of direct animal care (interviews, surveys). 

Civil society and research organisations pointed out that the financial burden on smaller 
operators and public authorities may limit the law's effectiveness and could reduce the 
law’s  overall  efficiency.  They  stressed  that  sufficient  financial  and  technical  support 
should be provided to help smaller operators comply without compromising animal health 
and welfare standards (interviews). 

Administrative burden 

NCAs reported that managing the complex requirements of the AHL, including reporting, 
disease monitoring, and compliance checks, has significantly increased their workload. 
This was particularly the case during the transition from previous systems, which required 
amending or repealing national legislation often coinciding with major disease outbreaks, 
further exacerbating the challenges. In addition, the need to coordinate across multiple 
national  and  EU-level  bodies  while  ensuring  compliance  with  various  regulations  was 
seen as time-consuming and resource-intensive (focus groups, interviews). 

Farmers and industry representatives  also  expressed concerns  about  the administrative 
demands,  particularly  for  record-keeping.  Some  suggest  that  the  AHL  could  be  more 
efficient  if  it  incorporated  more  risk-based  flexibility  in  reporting  and  certification 
requirements (validation workshop). 

A few veterinarians also noted that the AHL has increased their administrative workload, 
with additional reporting obligations, such as consolidating regulatory requirements and 
completing paperwork, adding to their responsibilities. This includes tasks like filling out 
disease notification forms, which were reported to require harmonisation across agencies, 
as well as paperwork related to compliance with sector-specific legal requirements (e.g. 
in aquaculture). This administrative burden has reduced the time available for hands-on 
veterinary  work,  potentially  affecting  the  quality  of  animal  health  care  (interviews, 
surveys).  Civil  society  and  research  organisations  emphasised  that  while  these 
administrative requirements are important for ensuring compliance, they can often create 
inefficiencies. They suggested that a more streamlined digital approach to reporting could 
reduce  administrative  burdens  while  maintaining  high  standards  of  animal  health 
(interviews). 

Opportunities for simplification 

Several NCAs suggested that the process could be made more efficient by harmonising 
reporting requirements, specifically addressing issues such as reporting overlaps and the 
proportionality of time invested versus the potential benefits gained. In addition, aligning 
national  procedures with EU-wide standards and  providing clearer guidance and more 

135 

      
targeted training for national authorities are also perceived as ways to help streamline the 
application of the law (interviews, focus groups). 

Farmers and industry representatives recommended reducing the complexity of animal 
movement reporting and certification processes. Digital tools such as e-certificates and 
integrated traceability systems were mentioned to simplify compliance and improve the 
speed  of  reporting,  reducing  the  burden  on  both  farmers  and  authorities  (surveys, 
interviews). They also proposed introducing more flexibility in how disease surveillance 
and biosecurity measures are applied, particularly for low-risk areas, to avoid unnecessary 
costs and paperwork (validation workshop). 

Veterinarians highlighted that digitalisation could be a key tool in simplifying reporting 
and  reducing  the  administrative  load,  without  further  specifying.  A  more  integrated 
system  for  health  certifications  and  disease  reporting,  linked  with  existing  veterinary 
databases, could save time and improve data accuracy (surveys, interviews). They also 
stressed the importance of ongoing training for veterinary professionals to ensure efficient 
and effective application of the AHL (focus groups). 

Civil  society  and  research  organisations  also  advocated  for  simplifying  the  AHL’s 
implementation by reducing redundant or overlapping requirements. A few organisations 
highlighted that the fragmentation of animal health and welfare legislation across the EU 
leads to duplicated procedures, inconsistent rules between Member States, and increased 
administrative  burdens—particularly  for  operators  involved  in  cross-border  activities. 
They  proposed  that  the  AHL  should  be  more  flexible  and  adaptable  to  the  needs  of 
different farming systems, allowing for a more targeted approach to disease management 
(interviews, surveys). Regular reviews and updates to the AHL could also help keep it 
aligned with emerging challenges without overcomplicating implementation. 

2.3   Relevance  

Addressing current and emerging needs 

Most NCAs considered the AHL fit and relevant to current and emerging animal health 
needs. They noted that its harmonised approach ensures that public authorities and the 
livestock sector can effectively tackle disease outbreaks across Member States (surveys, 
interviews). A few NCAs also emphasised that the law is flexible enough to accommodate 
the rapid evolution of specific diseases and public health threats, such as African Swine 
Fever and Avian Influenza (validation workshop, interviews). 

Farmers and industry operators expressed mixed views on the AHL’s capacity to address 
current and emerging needs. They noted that delegated and implementing acts allowed 
for quicker adjustments, while changes to the basic regulation are more complex and take 
longer, making it challenging to update measures when needed (interviews). 

Veterinarians generally agreed that the AHL is relevant to address current animal health 
needs but pointed out that certain sectors, such as aquaculture, face difficulties in adapting 
the  AHL’s  broad  framework  to  their  specific  requirements.  They  noted  that  while  the 
AHL  is  effective  for  broader  disease  management,  further  sectoral  adaptations  are 
necessary for full implementation (surveys, interviews). 

136 

      
Civil society and research organisations recognised the AHL's role in addressing global 
animal  health  challenges  but  stressed  the  need  to  improve  the  framework.  A  few 
international organisations and NGOs pointed out that the AHL has legal mechanisms for 
emergency  responses  but  that  improvements  are  needed  to  increase  preparedness  for 
climate-related risks (interviews, surveys). 

Adaptability to evolving threats and challenges 

The AHL’s ability to adapt to new and evolving threats was widely seen as a strength 
across stakeholders. NCAs particularly appreciated the flexibility provided by the AHL’s 
risk-based approach, which allows for targeted responses to emerging risks and evolving 
disease patterns (validation workshop, surveys). 

Farmers  and  industry  representatives  also  valued  the  AHL’s  adaptability  but  express 
concerns  about  the  speed  at  which  the  framework  can  respond  to  rapidly  spreading 
diseases.  For  example,  during  recent  Bluetongue  outbreaks,  differences  in  approaches 
across  Member  States  led  to  trade  disruptions  and  complications  in  disease  control 
(validation workshop, interviews). 

Veterinarians  highlighted  that  while  the  AHL’s  risk-based  approach  is  generally 
effective,  delays  in  its  application  to  newly  emerging  diseases  have  been  a  challenge. 
They  suggested  that  more  proactive  scanning  and  earlier  detection  of  potential  threats 
could enhance the system’s responsiveness (surveys). 

Civil society and research organisations echoed such concerns, mentioning the need for 
more frequent updates to remain effective in managing the risks posed by new diseases 
and  evolving  environmental  challenges,  including  climate  change  and  biodiversity 
concerns (interviews). 

Flexibility for local adaptation and resulting challenges 

There was consensus among all stakeholder groups that the flexibility of the AHL to adapt 
to  local  circumstances  is  both  necessary  and  beneficial,  particularly  for  addressing 
regional  disease  risks  and  outbreaks.  However,  stakeholders  also  agreed  that  this 
flexibility  must  be  balanced  with  the  need  for  harmonised  implementation  to  avoid 
inconsistencies  that  could  undermine  the  effectiveness  of  disease  control  and  disrupt 
cross-border trade. While adaptation to national contexts is important, they emphasised 
that it should not compromise the AHL’s core objective of ensuring coherent and effective 
disease management across the EU (validation workshop, interviews, surveys). 

2.4  Coherence 

Internal coherence  

There  was  overall  consensus  among  all  stakeholder  groups  that  the  AHL  is  coherent 
within  its  framework,  with  only  minor  inconsistencies.  While  some  NCAs,  farmers, 
industry  representatives,  veterinarians,  and  civil  society  organisations  acknowledged 
practical challenges such as the complexity of the legal language, varying implementation 
across Member States, and differences in interpreting certain measures, these issues were 
generally  seen  as  manageable  and  not  undermining  the  AHL’s  objectives  (validation 
workshop, interviews, surveys). 

137 

      
External coherence  

A  large  majority  of  NCAs  agreed  that  the  AHL  aligns  well  with  key  EU  policies, 
particularly  those  related  to  food  safety  and  trade.  The  law’s  emphasis  on  disease 
prevention  and  biosecurity  complements  EU  food  safety  regulations,  enhancing  cross-
border disease management and ensuring the stability and safety of trade in animals and 
animal products.  

Farmers representatives generally agreed that the AHL is coherent with animal welfare 
legislation but expressed concerns about its coherence with environmental policies. While 
they  valued  the  AHL’s  flexibility  and  risk-based  measures,  they  noted  challenges  in 
balancing  food  safety,  sanitary  requirements,  and  climate-related  objectives,  such  as 
maintaining  safety  standards  while  minimising  environmental  risks.  (interviews, 
surveys). 

A few industry representatives highlighted that while the AHL aligns with the Official 
Control Regulation, its connection to animal transport and welfare regulations remains 
unclear,  leading  to  inconsistencies  in  definitions  and  application.  Similarly,  farmers 
raised concerns about unresolved trade barriers despite internal harmonisation tools like 
regionalisation and  compartmentalisation. They  called for a more flexible approach to 
facilitate global trade (validation workshop, interviews). 

Veterinarians supported the AHL’s coherence with food safety policies, particularly its 
contribution to reducing the need for antibiotics and improving animal welfare. They also 
pointed  out  that  while  the  AHL  strengthens  biosecurity,  it  could  better  align  with  EU 
environmental  policies,  especially  those  addressing  climate-related  impacts  on  animal 
health (surveys, interviews). 

Civil society and research organisations supported the AHL’s alignment with EU animal 
welfare  and  food  safety  regulations  but  called  for  a  more  integrated  approach  with 
environmental policies. They argued that the AHL should better address environmental 
sustainability,  especially  in  the  context  of  climate  change  and  biodiversity.  They 
recommended a closer integration with EU climate strategies, the European Green Deal 
and the Farm to Fork Strategy, to ensure that animal health management contributes to 
both  immediate  health  goals  and  long-term  environmental  sustainability  (interviews, 
surveys, CfE). 

Addressing global challenges and fostering international cooperation 

NCAs recognised that the AHL has contributed significantly to enhancing international 
cooperation  by  providing  a  framework  for  managing  animal  health  that  is  globally 
recognised.  According  to  them,  the  law  has  facilitated  better  engagement  with 
international organisations, such as the World Organisation for Animal Health (WOAH), 
helping tackle global animal health challenges and ensuring the EU’s compliance with 
international  disease  control  standards.  Several  NCAs  also  noted  that  the  AHL  has 
strengthened the EU’s ability to collaborate with neighbouring countries on cross-border 
disease management, improving disease control and preventing outbreaks in both the EU 
and surrounding regions (surveys, interviews, CfE, validation workshop). 

Farmers  acknowledged  the  benefits  of  international  cooperation  fostered  by  the  AHL, 
particularly in maintaining access to international markets. The harmonisation of animal 

138 

      
health standards and the recognition of disease-free zones within the EU has facilitated 
trade  relationships  with  non-EU  countries  (interviews,  surveys,  CfE).  Industry 
representatives,  in  particular,  emphasised  the  role  of  the  AHL  in  raising  the  EU’s 
industry 
standards  for  animal  health,  which  are  recognised  globally.  A  few 
representatives  also  suggested  that  more  focus  should  be  placed  on  improving 
collaboration with low and middle-income countries, particularly in disease surveillance 
and capacity building (surveys, focus groups, validation workshop). 

Veterinarians  highlighted  that  international  cooperation,  especially  with  WOAH  and 
other regional organisations, has helped align the EU’s disease control efforts with global 
standards. This collaboration has further strengthened the EU’s position in global animal 
health governance. However, some veterinarians suggested that international cooperation 
could  be  enhanced  through  joint  training  programmes  and  data-sharing  initiatives  to 
tackle emerging global threats more effectively (surveys, interviews, CfE). 

Civil society and research organisations strongly supported the AHL’s role in fostering 
international  cooperation,  particularly  in  addressing  global  health  challenges  such  as 
zoonotic  diseases.  They  stressed  that  the  EU  should  continue  to  lead  in  global  health 
diplomacy, ensuring that its policies not only promote trade but also contribute to global 
health security (interviews, CfE). In addition, an international organisation pointed out 
challenges in interpreting key concepts, such as ‘disease control’ and ‘prevention,’ which 
differ between the AHL and WOAH standards.  

2.5  EU added value  

The added value of an EU-Level framework 

There was a consensus among all stakeholder groups on the added value of the EU-level 
framework provided by the AHL. Stakeholders agreed that harmonised rules at EU level 
are essential for effective disease prevention and control, facilitating trade, and ensuring 
a coordinated response to cross-border and global animal health threats. 

Most  NCAs  recognised  that  the  EU-level  framework  provided  by  the  AHL  has  been 
essential in harmonising disease prevention and control measures across the EU. The 
AHL  ensures  consistent  standards,  which  facilitates  trade  and  the  movement  of 
animals  within  the  EU,  a  benefit  that  national  measures  alone  would  likely  not  have 
achieved according to NCAs (validation workshop, surveys). Several NCAs highlighted 
that the EU-wide approach has proven particularly useful in managing global disease 
threats and maintaining a level playing field for Member States (surveys, interviews). 

Farmers and industry representatives valued the EU-level action for its uniformity in trade 
and  disease  management.  They  recognised  that  the  AHL’s  harmonised  rules  simplify 
compliance with both internal and external trade requirements, thereby strengthening the 
EU’s position in international trade (interviews, surveys).  

Veterinarians agreed that EU-level action is critical, particularly in avoiding fragmented 
rules and supporting uniform disease management. They stressed that without EU-level 
action, many Member States would struggle to implement effective disease prevention 
and biosecurity measures (surveys, interviews). 

139 

      
Civil society and research organisations generally echoed the positive views on EU-
level action, acknowledging that national systems alone could not have achieved the same 
harmonisation and cross-border coordination necessary for effective disease control 
(surveys,  interviews).  Several  organisations  mentioned  that  the  EU's  actions  ensure 
uniform  standards,  effective  cross-border  countermeasures,  and  uniform  health 
regulations,  which  are  crucial  for  managing  animal  health  in  the  integrated  European 
market (survey).  

Suggestions to further strengthen EU-added value 

Stakeholders across the board suggested several measures to enhance EU-added value 
under the AHL. NCAs proposed that the EU could provide more guidance and resources 
for  national  adaptation,  particularly  regarding  disease  management  and  biosecurity 
standards. This could include dedicated training and capacity-building programmes 
to ensure that national authorities are well-equipped to implement the law effectively 
(interviews, surveys). 

Farmers  and  industry  representatives  recommended  streamlining  documentation, 
improving  digital  tools,  and  making  the  legislative  structure  less  complex  to  make  it 
easier  for  small-scale  farmers  to  comply  (interviews,  surveys).  In  addition,  several 
farmers’  representatives  recommended  expanding  the  BTSF  programme  to  include  a 
broader range of stakeholders, as it is primarily designed for NCA and currently provides 
a limited snowball effect (validation workshop). 

Veterinarians also recommended further training and capacity building to ensure that 
the veterinary profession is fully equipped to support the AHL’s implementation. They 
suggested more harmonised  training programmes and better  data-sharing between 
Member States to improve disease surveillance and biosecurity measures (interviews, 
surveys).  Additionally,  a  few  proposed  peer-to-peer  training  for  animal  keepers  and 
veterinarians (validation workshop). 

140 

      
 
Annex VI Animal Health Law legal evolution and transitional phase (2016-2021) 

In accordance with Article 264(3) of the AHL, the Commission reported in 2020 on the exercise 
of its delegated powers71. That report confirmed that substantial legislative development took 
place between 2018 and 2020, culminating in the adoption of delegated regulations forming 
the  core  of  the  secondary  legal  framework  (see  Table  1).  By  the  date  of  application,  the 
Commission had adopted 10 delegated acts supplementing non-essential elements of the AHL 
and 13 implementing acts laying down detailed technical provisions. These acts established the 
operational framework required for uniform application across Member States  

Table 1: Delegated Regulations containing 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 
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 animals 
(EU) 
Commission  Delegated  Regulation 
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 

Empowerments 
2016/429 
Article 5(2) and (4) 

in  Regulation 

(EU) 

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) 

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) 

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141 

 
 
 
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) 

(EU) 
Commission  Delegated  Regulation 
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 

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 
listed  and 
emerging diseases 

for  certain 

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

requirements 

certification 

and 

142 

 
 
In its 2020 and its 2025 report72 on the exercise of delegated powers, the Commission confirmed 
the continuation of delegated acts adoption covering areas such as Union antigen, vaccine and 
diagnostic  reagent  banks;  the  use  of  certain  veterinary  medicinal  products  for  disease 
prevention  and  control;  and  rules  for  approval  and  recognition  of  disease-free  status  in 
compartments  keeping  terrestrial  animals.  By  mid-2025,  85  of  the  110  delegated  powers 
conferred under the AHL had been exercised. The report concluded that the empowerments 
remained necessary to ensure flexibility, allow regular adaptation to scientific developments 
and  address  areas  requiring  further  regulatory  specification.  On  this  basis,  the  Commission 
proposed extending the empowerments beyond the initial five-year period. 

Moreover, Article 274 of the AHL obliged the Commission to adopt certain delegated acts and 
one implementing act by 19 April 2019. The Commission had partially met this obligation as 
only three of those acts were published in the official journal in 2019, while the rest, even if 
ready and adopted by the Commission earlier, were published only in 2020. The drafting and 
adoption of the delegated and implementing acts was intense and technically demanding with 
60 expert group meetings between 2017 and 2019, and 41 in 2018 alone.  

Scientific advice, including EFSA opinions and alignment with international standards, was 
translated into operational legal provisions across a wide range of disease areas. The transition 
to  the  AHL  framework  required  Member  States  to  adapt  existing  national  systems  and 
procedures to directly applicable Union rules and the delays in adopting certain delegated and 
implementing  acts  posed  an  additional  challenge  to  Member  States.  To  facilitate  the 
adjustment, the Commission introduced transitional measures, issued guidance and organised 
technical exchanges alongside the legislative package. 

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143