EN EN

EUROPEAN COMMISSION

Brussels, 6.7.2026 COM(2026) 352 final

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')

{SWD(2026) 179 final}

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INTRODUCTION

Under Article 282 of Regulation (EU) 2016/429 on transmissible animal diseases ('Animal

Health Law')1 the European Commission (‘The Commission’) must carry out an evaluation of

that Regulation and delegated acts referred to in Article 264 of that Regulation and submit the

results of the evaluation in a report to the European Parliament and the Council. This present

document is intended to comply with this legal obligation and to serve as a report.

Accordingly, this report draws from the conclusions and lessons learnt and obtained throughout

the evaluation process. It builds on the results presented in Staff Working Document on the

evaluation of the Animal Health Law (AHL) and further outlining specific areas of particular

attention and certain future actions to be taken by the Commission and Member States.

2. BACKGROUND, SOURCES AND POLICY CONTEXT

Transmissible animal diseases do not respect borders, and even if they mainly affect animals

and cause economic losses, some of them may also affect humans. Harmonised rules with

measures to control such animal diseases are regulated in the EU for decades, e.g. some of the

first acts on animal health were adopted as far back as in 1964. With the introduction of the EU

Single market, these rules were further expanded and reinforced in the 90’s of the last century.

The AHL was adopted in 2016, entered into force on 21 April 2016 and applies from 21 April

2021. It aims to provide for a simpler and more flexible regulatory framework, ensuring a risk-

based approach to set out animal health requirements, enhanced disease preparedness,

prevention and control for listed transmissible animal diseases.

In addition, it reduces the administrative burden for farmers, other operators and competent

authorities without compromising animal health status in the Union. Furthermore, it provides

more suitable tools to deal with sanitary crises (e.g. emerging diseases) or to address specific

circumstances and contributes to less economic losses due to disease outbreaks.

This regulatory framework was adopted as a result of the EU Animal Health Strategy:

‘Prevention is better than cure’2 which followed a comprehensive evaluation of the EU Animal

Health Policy (CAHP) 1995-2004 and alternatives for the future3.

The AHL replaced 39 separate legal acts and introduced a single, harmonised and risk-based

framework for animal health across the European Union. The reform introduced a modernised

system of risk-based measures (e.g. disease categorisation), clearer allocation of

responsibilities among competent authorities and operators, enhancing prevention, most

particularly with strengthened biosecurity, reinforced preparedness, enabling vaccination and

upgrading contingency planning requirements. These are the core tools for disease control and

the structured use of regionalisation to ensure trade continuity.

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), OJ L 084 31.3.2016, p. 1. 2 EU Animal Health Strategy 2007-2013 - Food Safety - European Commission. 3 CAHP evaluation Final Report-Part I final.doc.

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This architecture enables the AHL to implement the principle of ‘prevention is better than

cure’, as set out in the 2007 EU Animal Health Strategy4. It represents a transition from reactive

crisis management to a proactive, risk-based approach that incorporates surveillance,

preparedness, prevention, early detection, rapid response, and recovery measures within a

unified legislative framework.

The AHL also contributes to broader Union policy objectives. It supports the One Health

approach by addressing the link between animal health, public health and the environment. It

aligns with the broader EU objectives by promoting sustainable and resilient agri-food systems.

Furthermore, it promotes sustainable competitiveness of the agri-food sector and strengthens

crisis resilience within the internal market by ensuring harmonised standards and coordinated

responses to transboundary animal diseases.

The Commission evaluated the Regulation (EU) 2016/429 in accordance with the EU Better

Regulation Principles and presented the results in the Staff Working Document on the

evaluation of the AHL and its supporting study5. The evaluation assesses the extent to which

the AHL has achieved its objectives since its entry into force on 21 April 2016, and more

specifically after becoming applicable on 21 April 2021. The study covered the period until 31

December 2023, while the Staff Working Document includes some more recent experiences

including until early 2026. Both documents draw on extensive evidence, including monitoring

data and stakeholder input collected through multiple consultations conducted as part of the

study and beyond, notably the CVO forum, Animal Health Advisory Committees, and other

expert groups. The evaluation also relies on Member State implementation reports and

notifications, Commission audits, data from the Animal Disease Information System (ADIS),

European Food Safety Authority (EFSA) scientific opinions, and findings from the EU

Veterinary Emergency Team (EUVET).

Overall, the results indicate that the AHL has mostly reached its main objectives, although with

a certain level of variation. The regulation is viewed by all key stakeholders as creating a strong

foundation for a harmonised animal health policy in the EU.

3. SUMMARY OF THE MAIN FINDINGS, LIMITATIONS

During the evaluation period, stakeholders and Member States faced several implementation

challenges. Although the AHL establishes a harmonised framework, its application across the

Union has not been uniform. As described in the SWD the consultation performed through the

supporting study indicates that differences in administrative capacity, governance structures,

and resources have affected the pace and extent of national alignment, with some Member

States still to finalise the necessary adjustments. The complexity of the legal framework,

including its delegated and implementing acts, has been highlighted as demanding, particularly

for smaller operators. Differences in interpretation and enforcement practices influence the

perception of equal treatment among stakeholders. These findings must be interpreted in light

of important limitations. The AHL has been applicable only since April 2021, providing a

relatively short timeframe to assess structural and long-term impacts. National alignment

4 https://food.ec.europa.eu/document/download/7820a76d-d19d-4a35-b223-

caae0f7143da_en?filename=ah_policy_strategy_2007-13_en.pdf. 5 https://data.europa.eu/doi/10.2875/0446681

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progressed at varying speeds, and in several cases pre-existing rules continued to apply

alongside AHL requirements, making attribution of impacts difficult.

The evaluation period also coincided with the COVID-19 pandemic, geopolitical disruptions,

increased costs and significant disease outbreaks, including highly pathogenic avian influenza

and African swine fever. These factors make it difficult to attribute impacts and limit drawing

definitive conclusions. The evaluation still provides early, indicative insights although a more

robust assessment will require additional time and data.

3.1 EFFECTIVENESS

The AHL has been widely acknowledged as a significant step forward in harmonising the EU’s

approach to animal health, moving from a reactive to a preventive system. The current

effectiveness of the AHL must be assessed in light of its ongoing implementation. Most

Member States have not yet completed the alignment of their national legislation with the

Regulation, with some showing substantial progress. For example, the Commission analysis of

Member States’ transposition of penalties according to the AHL shows that by June 2023 only

10 Member States reported that they have adopted, or were working on, rules which include

penalties applicable to infringements of the AHL. Delays are due to the complexity of national

legal systems and administrative structures. In addition, adapting to the new approach

introduced by the AHL will take time for all actors to master and therefore affects stakeholders´

perception of its effectiveness. This also explains the progressive transition.

The AHL has introduced a structured and science-based system for disease categorisation.

Transmissible animal diseases are listed under five categories (A to E) based on their

epidemiological profile, impact, and type of measures to be implemented to address them. This

categorisation enables proportional responses and prioritisation of resources, allowing Member

States to tailor their surveillance and control strategies to national contexts. This approach is

broadly supported but concerns remain about the system's responsiveness to emerging threats

and the need for more frequent updates, particularly considering climate-driven changes in

disease dynamics.

The AHL emphasises prevention through enhanced biosecurity. The regulation establishes

clear responsibilities for operators and competent authorities, requiring the implementation of

biosecurity measures at the farm level and across the production chain. While this has improved

awareness and risk mitigation, implementation remains uneven between different operations

(e.g. large vs. small scale). The lack of harmonised guidance and training has further

complicated the uptake in some Member States.

The reinforcement of stakeholder roles and shared responsibilities is another key feature. The

regulation clarifies the duties of farmers, veterinarians, competent authorities, and other actors

in the animal health chain. This has improved coordination and accountability, particularly in

disease notification, surveillance, and outbreak response. However, the evaluation study

highlights6 the need for broader awareness on the responsibilities of each actor and capacity-

building, especially among smaller operators and non-authority stakeholders. Despite EU-level

training initiatives as part of the Better Training for Safer Food initiative, dissemination at the

national level remains limited, and many stakeholders report difficulties in navigating the legal

6 External study, p 84.

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framework and understanding their obligations. In this regard, contingency planning and

simulation exercises can also play a role in involving operators and increasing awareness.

Delays in the alignment of national legislation have led to differences in the application of

certain new provisions, such as those on risk-based animal health visits. These visits are an

important tool for disease prevention and early detection. While some Member States have

integrated these visits into existing programmes, the extent to which this provision is

implemented remains difficult to assess due to a lack of data. In addition, a lack of enforcement

mechanisms and shortages in veterinary personnel, particularly in rural and remote areas,

further undermine full implementation.

The AHL strengthens the EU’s capacity to control and eradicate diseases through structured

eradication programmes and the recognition of disease-free areas7, which are essential to

maintain safe trade and reduce the burden of endemic diseases. However, uneven national

implementation has limited their full potential. Importantly, the use of regionalisation has

avoided major disruption of trade flows during outbreaks. The AHL allowed Member States to

apply targeted restrictions rather than blanket bans, enabling the safe movement of animals and

products from disease-free zones.

The evaluation recognised and welcomed the paradigm shift of the AHL which provides for a

wider and more flexible use of vaccination against animal diseases. The AHL has clarified the

conditions under which vaccination can be used as a preventive or emergency measure. This

has enabled more strategic deployment of vaccines, such as in the case of Highly Pathogenic

Avian Influenza (HPAI)8, where targeted vaccination campaigns have helped to reduce

outbreak severity and limit economic losses. This new policy contributed importantly to

limiting negative effects of several animal diseases. Most often mentioned examples are HPAI,

with recent preventive vaccination in France since 2024, bluetongue virus (BTV) in several

Member States, lumpy skin diseases (LSD) in Italy, France and Spain in 2025-2026 as well as

foot and mouth diseases (FMD) in Slovakia, Hungary (2025) and Cyprus (2026). However,

some called for broader support for vaccination, such as expanded EU antigen and vaccine

banks beyond only Category A diseases and called for a more structured and coordinated

vaccination plan against animal diseases in the EU.

The upgrade of digital tools such as TRACES for traceability and animal movements and ADIS

for reporting and notification are seen as an improvement and have been recognised as a step

forward in simplifying procedures, although technical and interoperability issues persist9.

While the implementation of the AHL has aimed to harmonise and simplify animal health

requirements across the EU, some unintended effects have been observed, particularly for

small-scale operators, such as hobby keepers. In particular, in certain cases, the requirements

introduced at the national level, which sometimes go beyond what is set by the AHL, have

resulted in increased administrative and financial burdens. Additionally, while the AHL does

not regulate financial support, the lack of adequate compensation mechanisms has been noted

by stakeholders as a barrier to effective implementation.

7 External study, p 111. 8 SWD, point 2.3.3. 9 External study, Point 4.12. page 69.

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The AHL effectiveness is evident in areas where implementation has progressed, particularly

in disease categorisation, risk-based surveillance, biosecurity, and eradication efforts.

However, overall the implementation is still in a transition phase. Continued support for

Member States, simplification of legal instruments, and broader stakeholder engagement will

be essential to fully realise the regulation’s potential. As national systems continue to align

with the AHL, a more comprehensive assessment of its long-term impact will become possible.

3.2 EFFICIENCY

The evaluation of the AHL efficiency examines whether the costs incurred by Member States,

stakeholders, and the Commission have been proportionate to the benefits achieved since its

implementation. However, a significant limitation of the evaluation is that Member States have

not yet fully aligned their national legislation with the AHL, nor fully utilised the flexibility

offered by the AHL. As a result, it remains challenging to disentangle the impact of the AHL

from that of not fully aligned national legislation. Additionally, several years may be required

before the effects of the AHL are reflected in actual changes to animal health status, especially

considering that external factors markedly influence the epidemiological landscape.

Overall, the cost-benefit balance of the AHL is expected to be positive in the long term, though

with important qualifications. In the short to medium term, the AHL has entailed substantial

costs and administrative efforts for various stakeholders, and these upfront costs have in some

cases been higher than initially expected. These costs and efforts are investments expected to

yield clear future benefits in disease prevention and control, regulatory harmonisation, and

trade facilitation. Such benefits are expected to grow over time. The AHL’s emphasis on

prevention (e.g. biosecurity measures and surveillance) is expected to reduce costly disease

outbreaks in future years, leading to savings that justify the current expenditures. Nonetheless,

the efficiency gains are not yet fully achieved, as the regulatory transition is still ongoing. In

this early implementation phase, the AHL’s benefits have materialised unevenly, while certain

costs are front-loaded.

Some National Competent Authorities have borne substantial one-off and ongoing costs to

align national systems with the AHL. These include efforts to update or consolidate national

legislation, upgrade IT systems (e.g. for disease notification and traceability), recruit or train

staff, and communicate new requirements to stakeholders. Many national authorities had to

redirect significant resources to adapt their surveillance and reporting infrastructure.

New compliance costs for operators also appeared. These stem from obligations such as

enhanced disease surveillance and biosecurity, record-keeping for animal movements, and, in

some cases, requirements such as animal health visits and registrations of new establishments.

However, depending on the specific measures, they were not entirely new to all operators. For

instance, some farmers in particular sectors and countries were already subject to animal health

visits prior to the implementation of the AHL, either due to national legislation or to

participation in private certification schemes. Consequently, the extent to which the AHL has

introduced new costs varies across operators, sectors, and Member States.

According to the study, the benefits observed or anticipated under the AHL include a more

effective and efficient disease control and a more coherent regulatory environment. By

replacing 39 legal acts with a single regulation, the AHL was designed to streamline rules and

reduce legal fragmentation. In principle, this consolidation has given more legal certainty and

should improve clarity and save administrative effort in the long term. Indeed, many

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stakeholders report that having a unified framework has improved coordination between

authorities and stakeholders and facilitated a quicker, more unified response to transboundary

disease threats. There is evidence that the AHL’s measures (such as risk-based surveillance

and regionalisation) have helped contain recent animal disease incursions (e.g. avian influenza,

African swine fever) more efficiently, thereby reducing the scale of culling, trade bans, and

other costly emergency measures. Trade data and stakeholder feedback indicate that the

internal market has remained resilient. Intra-Union trade recovered strongly after 2021 despite

ongoing outbreaks of animal diseases, suggesting that the AHL framework has supported trade

continuity10. By harmonising standards and approaches across the EU, the AHL helps maintain

trust in intra-EU trade of animals and animal products and prevents unjustified trade barriers

during disease events (use of disease zoning/regionalisation rather than nationwide bans).

These benefits, while harder to quantify immediately, contribute to a more stable and

predictable operating environment for businesses and authorities. Taken together, the above

elements suggest that the AHL is delivering value that should, over time, balance out the

investments made.

Despite its long-term advantages, certain operators claim that the implementation has

introduced administrative burdens, particularly in the initial stage. They have raised concerns

about increased paperwork, the complexity of new procedures, such as establishments

registration, record keeping, animal health visits, and overlapping requirements between

national and EU requirements. Certain target groups have been especially affected. In

particular, small-scale farmers and hobby animal keepers have reported that complying with

the AHL’s requirements (such as obtaining animal health certificates for animal movements,

or meeting new record-keeping and biosecurity rules) is, in their view, onerous and

disproportionate to the scale of their operations. Larger commercial operators also note some

increased compliance costs, but these tend to be more easily absorbed in bigger businesses.

The efficiency and cost-benefit experience of the AHL varies significantly between Member

States and groups of operators. Member States that entered the AHL era with a developed

veterinary infrastructure, advanced IT systems, and well-resourced administrations have

generally managed the transition more smoothly and even capitalised on it. For example,

countries that introduced a national computerised database for animal traceability ahead of the

AHL have built up on this system and reported improvements in surveillance and early

detection capacity. This example highlights that where investment has been made in

infrastructure and capacity-building, the AHL’s operational efficiency can be realised more

effectively. By contrast, Member States with more limited resources or less developed systems

have faced steeper challenges and higher relative costs. Such disparities also affect stakeholders

like farmers; for instance, if a country delays rolling out updated guidance, farmers and

veterinarians in that country might struggle for longer with confusing procedures.

Moreover, the distribution of costs and benefits among stakeholder categories also varies

depending on the extent Member States use the flexibility granted by the AHL11 12. In Member

States that did not fully embrace a risk-based approach, the farming community felt a heavier

burden. In other Member States that applied the flexibilities of the AHL to tailor measures to

local risk (for example, exempting very small keepers from certain duties), the private sector’s

burden was relatively lighter. These policy choices, along with differing economic structures

10 SWD, Point 4.1.1, page 44. 11 External study, Annex 3, p. L 12 SWD, point 4.1.2, p 46.

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(large commercial farms vs. many smallholders), mean that the AHL’s efficiency can be

viewed differently from one country or sector to another.

3.3 COHERENCE

The evaluation shows that the AHL is internally coherent. Union disease listing and

categorisation determine the level of surveillance, movement conditions and control measures,

creating a structured link between risk assessment and operational response. In practice,

however, differences remain in how Member States design surveillance systems, manage

wildlife interfaces and apply derogations during outbreaks. As several Member States are still

completing national alignment, full operational consistency has not yet been achieved.

Externally, the AHL operates alongside other Union legislation in a complementary manner.

The Official Controls Regulation provides the horizontal framework for verification and

enforcement in the EU along the agri-food chain. The AHL acts upstream of General Food

Law13 and zoonoses legislation14 by addressing animal health risks before they affect food

safety or public health. It also aligns with the EU legislation on veterinary medicinal products15

especially where vaccination or treatment forms part of disease control strategies. The AHL

seeks to provide a coherent application of ‘One health’ concept, addressing the

interconnections between animal and public health, wildlife, the environment, food and feed

safety, animal welfare and taking other external factors, such as food security, economic

factors, social issues into consideration16.

Consistency with food safety and animal welfare legislation is overall assessed as strong 17,

although stakeholder views on practical alignment with animal welfare legislation are mixed,

particularly where disease-control measures under the AHL may have implications for animal

welfare.

The AHL applies to wildlife only where it is epidemiologically relevant for the prevention or

control of listed diseases. Certain areas, particularly transmissible spongiform

encephalopathies and most rules on animal by-products, continue to be regulated under specific

legal frameworks outside the AHL.

3.4. RELEVANCE

The AHL remains highly relevant in light of evolving epidemiological pressures, including

recurrence of certain diseases, the continued spread of others such as African Swine Fever

(ASF), highly pathogenic avian influenza (HPAI) and the expansion of vector-borne diseases.

13 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 and laying down procedures in matters of food safety,

http://data.europa.eu/eli/reg/2002/178/2026-01-01. 14 Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the

monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing

Council Directive 92/117/EEC, http://data.europa.eu/eli/dir/2003/99/oj. 15 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on

veterinary medicinal products and repealing Directive 2001/82/EC,

http://data.europa.eu/eli/reg/2019/6/oj. 16 External study, p.78. 17 SWD, p59.

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Its preventive orientation, use of regionalisation and other tools as vaccination provide

appropriate tools to address increasingly complex disease dynamics.

Overall, the AHL is considered fit for current needs and sufficiently adaptable to emerging

threats through uniform minimum requirements for diseases categorised as category A and B

and more flexible approaches for diseases categorised as category C, D and E. However, the

operators indicate several challenges in this regard. The flexibility provided for diseases

categorised as C, D and E enables Member States to tailor measures to national circumstances

but may also lead to heterogeneous application of measures (for example, vaccination against

bluetongue), which are beneficial for controlling the disease in the Member States but can

impact intra-EU trade and market predictability. In addition, biosecurity obligations and animal

health visit requirements, while clearly defined in principle, were identified by stakeholders as

areas where more detailed and harmonised operational guidance would support more consistent

implementation.

3.5 EU ADDED VALUE

The evaluation confirms clear EU added value. By establishing harmonised rules for animal

health and in particular for disease surveillance, prevention and control, the framework

supports coordinated action across Member States and contributes to a level playing field

within the internal market. Union-level tools, such as disease listing and categorisation, antigen

and vaccine banks, EU disease notification and reporting system, network of EU animal health

laboratories, regionalisation and common rules for movements and entry into the Union,

underpin predictable cross-border coordination and facilitate safe trade. Moreover, the AHL

framework ensures that requirements for entry into the Union are as stringent as those applying

in the EU, creating an equal level playing field for the EU operators. These entry requirements

in line with the international standards of WOAH permit international trade in accordance with

WTO/SPS principles. These outcomes could not have been achieved to the same extent by

Member States acting alone 1819.

The balance between EU and national action is broadly proportionate. However, the outcomes

show some limitations affecting 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 certain operators. On that

the consultation pointed out that further coordination at Union level could improve consistency

and market predictability while maintaining necessary flexibility.

4. LESSONS LEARNED AND NEXT STEPS

As indicated, although the AHL has only been fully applicable since 2021, the evaluation

confirms an overall positive assessment and widespread appreciation among stakeholders. The

AHL is widely regarded as a significant improvement on the previous fragmented framework,

providing a modernised, risk-based legal architecture and is considered to provide a strong and

coherent foundation for a harmonised, preventive, and risk-based animal health policy in the

EU. It supports a shift in focus from eradication to prevention, preparedness and proportionate

18 External study, p139. 19 SWD, p 69.

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long-term disease management, thereby strengthening the predictability and sustainability of

EU animal health policy.

Despite positive overall feed-back and appreciation, the complexity of tertiary legislation,

uneven implementation and delays in national alignment have limited the full realisation of the

framework’s potential. The Commission identified certain areas where further attention is

needed. These areas, identified across the evaluation criteria and requiring further attention by

the Commission and Member States have crystalised in the points presented below.

4.1 Strengthening the single policy and legal framework

The evaluation recognises the AHL as a clearer, modernised legal structure that ensures more

consistent application of animal health rules across the EU. The AHL is widely seen as a

structural improvement compared with the previous framework. It further reduces reliance on

emergency eradication measures alone and supports more sustainable, predictable, flexible

long-term disease management.

On the other hand, the evaluation points towards complexity of tertiary legislation, unevenly

implemented or not yet enforced rules across Member States. These also report that alignment

with national legislation was more complex than anticipated. The study also identified a certain

level of frustration as regards the time needed for the adoption Delegated Acts, which is longer

than initially assumed by certain stakeholders.

To address these issues, the Commission should continue aligning and streamlining tertiary

legislation to make it easier to navigate and more user friendly. In addition, the Commission

should increase the user friendliness and updates of the Commission website with explanations

on integration and operation of different pieces of legislation and their inter-connections. If

necessary, the Commission can develop Guidance on various elements of the legislation,

adopted in the format of “Commission notice” when relevant. Better Training for Safer Food

(BTSF) training must continue and reinforce the transfer of knowledge across Member States.

Member States must accelerate and ensure full transposition of the AHL by removing obsolete

national legislation. Where needed, they should develop national or sectorial guidance as

relevant for the topic to complement the Commission Guidance, especially to address specific

circumstances and situations. Moreover, Member States must distribute downstream the

knowledge obtained through BTSF training more effectively and efficiently in the official

services and operators.

4.2 Clarifying responsibilities of different actors and strengthening compliance

The evaluation showed a clearer allocation of obligations and reduced uncertainty about who

is responsible for prevention, notification, control and recovery measures. It shows that the

AHL introduced a shared-responsibility principle, increased awareness among stakeholder

groups, particularly veterinarians and the competent authorities, which has facilitated more

organised cooperation during disease outbreaks. This has also contributed to improved

compliance.

However, responsibilities can still be unclear at local operational level, particularly during

outbreak situations. The evaluation showed shortcomings in local operational planning,

stemming from lack of training and coordination, rather than from deficiencies in the AHL

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framework. Practical application of the framework is further complicated by layered delegated

and implementing acts. Moreover, there is a legal obligation for Member States to report to the

Commission on the penalties applicable to infringements of the provisions of the AHL. Few

Member States reported about their acts providing for penalties 20.

To address these issues, in addition to the elements mentioned under point 4.4, the Commission

aims to adopt an implementing regulationon contingency plans.

Regular publication of comparable information on national penalties and enforcement practices

can be envisaged in order to enhance transparency regarding national sanctioning systems and

to promote accountability and mutual trust. In light of this reflection, the Commission could

initiate a discussion in the framework of Animal Health Advisory Committee (AHAC) and

Standing Committee for Plants, Animals, Food and Feed (PAFF) on the added value of

establishing requirements on minimum level of sanctions or other guidance to Member States

on how to apply sanctions.

Member States must reinforce their efforts in transposing rules and develop the necessary

sanctions to ensure a proper implementation of the AHL nationally and give the competent

authorities the necessary tools to enforce the legislation.

4.3. Ensuring adaptability of disease categorisation/prioritisation

The evaluation concludes that disease prioritisation and categorisation is a valuable key

measure which supports proportionate, science-based EU measures. However, concerns remain

about adaptability and the timeliness of updates and adaptability to emerging risks and diseases

posing specific challenges such as vector-borne diseases.

The Commission will therefore review and verify whether the current categorisation system

still fits the current circumstances. It will also review if categorisation criteria adequately

address specific challenges (e.g. vector borne diseases, where a request for an EFSA opinion

has already been launched) and may propose changes to legislation, if needed. The Commission

will further mandate EFSA and consider launching a more comprehensive assessment and

where relevant, re-assessment of animal diseases for their listing for Union intervention and

categorisation under the AHL.

4.4. Improving the response to animal diseases and contingency plans

The evaluation concluded that the adoption of the AHL has led to better coordinated responses

to animal diseases. In addition, rules for contingency plans will further contribute to improved

response to disease outbreaks.

However, implementation of disease control measures across Member States remains uneven.

On the contingency plans, stakeholders note the absence of implementing rules and the Study21

concluded that contingency plans are outdated in several Member States.

20 SWD, p.27. 21 External study, p 66.

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To strengthen the disease control measures in the EU, the Commission willcontinue to revise

and amend delegated regulations22to adjust them to the most recent scientific developments

and Member States’ needs. To ensure uniform implementation of contingency plans, the

Commission will adopt an implementing regulation.The Commission will further support

Member States by continuous BTSF training, focussing on continued support provided on

animal health. The Commission will launch a specific series of Commission audits in Member

States to monitor Member States’ States implementation of simulation exercises and the

implementation of the rules on contingency plans.

4.5. Enhancing regionalisation and compartmentalisation

The evaluation indicated that the disease control measures introduced by the AHL that have

helped minimise the impact of disease outbreaks, support the recognition of disease-free areas

in the EU and enable continued intra-EU trade and exports. This has been achieved using EU

regionalisation, and to a lesser extent also newly introduced concepts of compartmentalisation,

enabling the continued trade within the EU and exports to non-EU countries.

However, an uneven recognition by third countries of regionalisation and related tools reduced

expected benefits for international trade continuity. Several stakeholders call for more practical

guidance, knowledge and capacity building.

To address these issues, the Commission will further support Member States by developing

Guidance on the application of regionalisation and compartmentalisation, to improve

understanding. A user-friendly Commission website will provide explanations of different

pieces of legislation and visualisation of regionalisation through innovative IT mapping tools.

The Commission and Member States will also continue advocating for the recognition of EU

regionalisation with the trading partners at bilateral and multilateral meetings, within trade

agreements, SPS negotiations and international standard setting bodies.

4.6. Addressing uneven implementation in Member States, risk-based measures and

flexibility

Weak and uneven implementation of the AHL in the Member States is amongst the most often

mentioned findings of the evaluation and perceived as a weak point. At the same time, the

measures in the AHL are based on risk. In that respect, the legal framework offers opportunities

to provide flexibility through more detailed rules i.e. delegated and implementing acts adopted

on the basis of the AHL. The AHL also gives Member States the possibility to implement

stricter rules in certain areas. Although some Member States have good practices to ensure

proper implementation of the new regulatory framework, and the added value of BTSF

trainings is clear, the implementation in many Member States remains only partial.

With respect to flexibility, while the evaluation highlights the AHL’s added value, especially

when implementing disease control measures, it also stresses that this leads to uneven

enforcement and to different use of derogations in Member States. This was perceived as a

factor affecting the single market and creating unequal conditions for certain sectors in different

Member States and there was a call for more consistent implementation across the EU.

22 http://data.europa.eu/eli/reg_del/2020/687/oj.

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To address this, the Commission can reinforce Commission audits in Member States to closely

monitor and stimulate a better and more even level of implementation. If considered necessary,

the Commission may limit/frame the use of Member States derogations through the

modification of delegated and implementing acts and ensure more prescriptive harmonised

rules. The Commission and Member States could increase transparency by keeping up-to-date

and transparent national and Commission websites, by providing information at Standing

Committee on Plants, Animals, Food and Feed (PAFF Committee) and making it publicly

available on the PAFF Committee website. Moreover, continued BTSF training will, by raising

knowledge, providing information and conducting practical exercises, continue supporting

Member States’ implementation.

4.7. Emphasis on risk-based prevention, biosecurity and surveillance measures

The evaluation noted an important progress in obtaining disease free statuses for several listed

animal diseases, for which eradication is compulsory in the Union, such as tuberculosis,

brucellosis or rabies, introducing a shift from an eradication-centric model to prevention and

control23. The evaluation shows that surveillance is reinforced under this framework applying

a risk-based approach. On the other hand, it observed a mixed application of basic operator’s

surveillance through animal health visits according to Article 25 of the AHL, uneven

enforcement of biosecurity, and pointed to resource issues, especially a shortage of

veterinarians. Enhancing national-level surveillance networks and ensuring alignment with

EU-level indicators to maintain a level playing field across Member States,24 could help in

implementing a flexible, risk-based approach that adapts to the local context which is only

justifiable if it is underpinned by robust surveillance systems.

To address a request repeated in the evaluation, the Commission can develop rules with criteria

and baseline frequency of animal health visits and develop guidance on biosecurity, where the

Member States in their reflection explicitly preferred guidance to legislation.

4.8. Optimising the use of vaccination across the EU

As indicated in point 3.1, the evaluation recognised and welcomed the paradigm shift of the

AHL which provides for a wider and more flexible use of vaccination against animal diseases

and shows some good examples. More recently, an unprecedented volume of animals to be

culled due to the spread of diseases justifies calls for broader use of vaccination also as a

prevention tool where possible.

In response, the Commission will verify whether the current vaccination rules and principles

included therein are fit for purpose and if the approach for different Category A diseases

addresses the needs, taking into consideration potential impacts of such changes to the

economy, society and trade. This work should be undertaken within a broader international

multilateral context, taking into account not only EU rules but also international standards and

trade requirements. The Commission will therefore continue to engage with WOAH, trading

partners and other international stakeholders to promote science-based approaches to

vaccination, contribute to the development of international standards and, reduce unjustified

trade related barriers associated with the use of vaccination. The Commission will also

regularly discuss with Member States and industry how to ensure better availability of vaccines

23 Point 3.4. of Staff Working Document, p.26. 24 Point 5.6. of External study.

13

for such animal diseases. The Commission will also ask for scientific advice supporting the

decision-making process on how to best use vaccination under different scenarios and for

different purposes, i.e. to support disease control measures with emergency vaccination or to

use it as a disease prevention tool.

4.9. Reducing administrative burdens, costs, reporting and complexity of certain

measures

The evaluation study perceived the introduced risk-based measures as more cost-effective.

Some specific benefits are already visible, for example improvements in early detection of

avian influenza in certain regions25. However, these benefits are not yet widespread. Training

and the implementation of new obligations, such as animal health visits, also generated

increased costs.

Moreover, in some cases, as for example for ASF, specific rules introducing additional zoning

elements and movement restrictions on top of the general AHL framework provisions, were

perceived as more complex, reintroducing a disease-by-disease approach, increasing

documentation requirements and creating confusion for operators and trading partners.

Member States and operators also reported increased workloads related to early detection and

surveillance of animal diseases.

On the other hand, some simplification occurred in practice. The Commission has issued

clarifications to distinguish low-risk movements (e.g. certain pets and captive birds), and some

Member States have introduced national measures such as waiving fees for hobbyist

certificates. Simplification is proved to be possible within the existing legal framework.

However, the evaluation study also pointed towards diverging national obligations and top up

EU rules, which many perceive as problematic.

The Commission will therefore continue pursuing the use of simplification possibilities

through amending the existing delegated and implementing acts, taking an evidence- and risk-

based approach. The Commission can also consider limiting or better framing the use of

Member States’ derogations through the modification of delegated and implementing acts

and ensuring more harmonised rules.

4.10. Addressing funding concerns

The evaluation study highlights several instances of the lack of adequate financial mechanisms,

in particular to compensate farmers for their losses due to disease outbreaks and related costs.

Although the study considered this was an unintended effect, it noted that the clarification of

responsibilities shifted the financial obligations to farmers.

Experience as regards EU co-financing has shown that the unpredictability of large-scale

outbreaks of certain animal diseases, leading to major crises, point to a need to ensure access

to a crisis reserve fund suitable for financing animal diseases emergency measures.

The Commission noted these concerns which will be also addressed through the Livestock

Strategy and the new Multiannual Financial Framework.

25 SWD, Point 4.1.1., page 39-41.

14

4.11 Strengthening external coherence and links with other legislation:

The evaluation confirms that the AHL is broadly aligned with other EU policy frameworks,

including the One Health approach. Its objectives reinforce those of the single market, public

health, food safety, and environmental protection. Nonetheless, some inconsistencies remain.

4.11.1. One Health approach

Meaningful alignment of the AHL with the One Health approach is observed. The AHL reflects

a clear legislative commitment and remains relevant to its overarching objectives. However,

the extent of its practical alignment and operational effectiveness is perceived differently by

various stakeholder groups and is characterised by both notable strengths and persistent

challenges in implementation and integration26. Its effective application continues to face gaps,

especially in the integration of environmental health and cross-sectoral collaboration and

stronger coordination across animal, human and environmental health systems, particularly for

zoonotic and wildlife-related risks.

The Commission will further support efforts of Member States to enhance coherence and

strengthen multidisciplinary integration in the countries with emphasis on sharing best

practices.

In the new implementing regulation on contingency plans (see also above), which is planned

for adoption in 2026, the Commission will require Member States to clarify procedures for

cooperation of veterinary authorities with their public health counterparts, and when relevant

environmental and other authorities.

4.11.2. AHL and the link with rules on transmissible spongiform encephalopathies

(TSE) and on zoonoses

Despite the fact that AHL has introduced a well-structured, risk-based approach for animal

disease control, its coherence with pre-existing, legislation on Transmissible spongiform

encephalopathies (TSE) Regulation27 - remains partial. Stakeholder input, particularly from

competent authorities, has highlighted that maintaining separate legal frameworks for TSEs

and other zoonotic diseases has resulted in regulatory fragmentation and implementation

difficulties. The fact that TSEs are not included in the AHL's disease categorisation process

results in confusion among operators and authorities, it complicates disease prioritisation,

influences co-financing decisions and weakens communication of health risks28. According to

the study, addressing these inconsistencies would support both legislative coherence and more

efficient allocation of disease-related EU funding.

26 External study, point 4.3.7, p 143. 27 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. 28 External study, point.4.4.2, p 151.

15

The Commission is already addressing certain aspects of the TSE rules in the ongoing Food

and Feed Safety simplification omnibus29 adopted in December 2025. In addition, it will launch

a comprehensive revision of the TSE rules and consider bringing them under the AHL.

The Commission will also review, simplify and update the existing zoonosis directive and

reflect how to incorporate other zoonotic agents under the AHL framework.

4.11.3. Clarifying interfaces with animal welfare

Although the evaluation study didn’t identify any direct legal contradiction/friction with animal

welfare rules, perception of misalignment exists, especially in the areas of animal transport and

culling practices during outbreaks, particularly in some farming systems. Normally such

concerns relate more to the specific and in many cases local implementation of certain

temporary disease control measures and broader farming practices rather than to the legal

provisions.

The Commission can further address these through scientific advice provided by EFSA and in

the Livestock Strategy. The Commission can also consider organising a dedicated BTSF for

specific issues at the interface between animal health and animal welfare in different outbreak

scenarios, particularly during emergency situations affecting transport, housing conditions or

culling of animals during disease outbreaks.

5. CONCLUSIONS

In conclusion, the evaluation shows that the AHL presents a strong foundation for a harmonised

animal health policy in the EU. Its shift towards prevention, risk-based decision-making, and

integration with broader EU goals marks a substantial improvement over the previous system.

However, uneven implementation, perceived complexity in legal instruments, and limited

stakeholder understanding continue to pose challenges.

The Commission identified areas and actions that could address these issues, for instance

through simplification, capacity building, enhanced cooperation between operators, and

Member States and the European Commission aiming at introducing a more preventive

approach. These would help the AHL to fulfil its potential in safeguarding animal and public

health, promoting resilience, and supporting the competitiveness of the EU’s agri-food sector.

The priority at this stage is not a fundamental reform, but consolidation, clarification and

consistent implementation across the Union. Continued monitoring and evidence gathering will

inform any future legislative adjustments.

29 Simplification of legislation - Food Safety - European Commission.

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 Animal Disease Information System

AHL Animal Health Law

AMR Antimicrobial Resistance

ASF African Swine Fever

BSE Bovine spongiform encephalopathy

BRG Better Regulation Guidelines

BT/BTV Bluetongue (Bluetongue virus)

BTSF Better Training for Safer Food

BVD Bovine Viral Diarrhoea

CBA Cost-Benefit Analysis

CfE Call for Evidence

CPs Control Programmes

CSF Classical swine fever

COMEXT External Trade Database

CVO Chief Veterinary Officer

DG SANTE Directorate General for Health and Food Safety

EBL Enzootic Bovine Leukosis

EC European Commission

EEA European Economic Area

EFSA European Food Safety Authority

EFTA European Free Trade Association

EHD Epizootic Haemorrhagic Disease

EMA European Medicines Agency

EU European Union

EUROSTAT Statistical Office of the European Communities

EUVET EU Veterinary Emergency Team

FMD Foot-and-mouth disease

FVE Federation of Veterinarians of Europe

HPAI Highly Pathogenic Avian Influenza

IA and DA Implementing and Delegated Act

IBR Infectious Bovine Rhinotracheitis

IHN Infectious Haematopoietic Necrosis

IT Information Technology

MS Member State

NCA National Competent Authority

NGO Non-Governmental Organisation

OCR Official Control Regulation

PPR Peste des Petits Ruminants

SPGP Sheep Pox and Goat Pox

SME Small and Medium-sized Enterprise

SPS Sanitary and Phytosanitary Measures

TRACES Trade Control and Expert System

TSE Transmissible Spongiform Encephalopathies

WAHIS World Animal Health Information System

WOAH World Organisation for Animal Health

WTO World Trade Organisation

5

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.

6

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

7

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.

8

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.

9

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.

10

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

11

12

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.

13

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

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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 impacts on animal health, public health and trade, while avoiding

disproportionate disruption.

15

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.

16

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

17

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 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.

4 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 and laying down procedures in matters of food safety,

http://data.europa.eu/eli/reg/2002/178/2026-01-01.

18

19

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.

20

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.

21

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.

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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

23

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 Eurostat: Livestock populations (apro_mt_lscatl, apro_mt_lsgoat, apro_mt_lssheep, apro_mt_lspig,

agr_r_animal). Farm structure (ef_lsk_poultry). 8 Eurostat: Farm structure (ef_m_farmleg). 9 Farm Sustainability Data Network (FSDN). 10 COMMISSION STAFF WORKING DOCUMENT Summarising evidence supporting the

legislative proposal on the welfare of dogs and cats and their traceability

https://food.ec.europa.eu/document/download/caf8cd1d-967a-4e60-a0e5-19401be1c6b3_en.

24

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 provisionsinto 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 EUR-Lex - 52021DC0057 - EN - EUR-Lex. 12 Delegated and implementing acts - Food Safety - European Commission.

25

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.

26

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

27

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.

28

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.

29

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;

30

• 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

31

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.

32

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

33

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

34

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

35

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

re-emerging diseases, maintain long-term eradication programmes, and adapt

surveillance and controlstrategies 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

36

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.

37

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 External study, Annex V, p XCVI. 16 External study p 56 , Annex V p XCVI. 17 European Parliament (2020) Parliamentary question - E-004906/2020(ASW). Available here. 18 External study, p 57.

38

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 External study, p 52. 20 External study, p 55.

39

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.

21EFSA 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. 22 See Annex V - Synopsis report.

40

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 External study, p 67. 24 External study, p 82.

41

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.

42

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

43

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.

44

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 External study, p.71. 27 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. 28 External study,p.68.

45

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 refinement would further strengthen

responsiveness to future risks.

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

46

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

47

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

epidemiological developments. Robust attribution would require dedicated

counterfactual modelling beyond the scope of this evaluation.

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

48

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

49

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

implementation, with smaller farms and aquaculture operators bearing a

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.

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.

50

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

Once

every 3

years

18

hours (1

00%

modalit

y)

12,6

hours (3

0%

reductio

n)

20.4

22610 - 7610526 2536842

Bovines 173.3 22810 73370 43906057

14635352

Ovine and

caprine 140 50010 37170

40123049

13374350

Poultry 180 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 External study, p.100. 31 External study, Annex 3, p70.

51

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)

Application for registration and

development of animal health and

treatment plans (one-off)

1.5 24.2 - 36.3

Record keeping (yearly)

for the average farm size 10

24.2

10760 2603920

Record keeping (yearly) for below-

average farm size 8 16310 3157616

Record keeping (yearly) for above-

average farm size 12 4540 1318416

Total 7079952

Source: External study

32 External study, Annex 3, p LVI. 33 External study,p.102. 34 External study,p.102.

52

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 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. 36 External study, Annex 3, p. LIX.

53

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

54

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 External study, p. 102. 38 External study, p. 104. 39 External study, Annex 3, p. CV. 40 External study, Annex 3, p. LI. 41 External study, Annex 3, p. LXIV.

55

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 External study, Annex 3, p. 107. 43 External study, p. 107. 44 External study, p. 107.

56

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

outweigh costs, compared to 6/19 who see costs as predominant.

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.

57

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 External study, Annex 3 p. LVIII.47 External study, Annex 3 p. LXXXV. 48 External study, Annex 3, p. LI. 49 External study, Annex 3, p. LXIV.50 External study, Annex 3, p. LXXXVII.

58

Buying the vaccine 24 State 22464 22464 0

Vaccine storage and transport 4 State 3744 3744 0

Supervision of vaccination

(official vets) 18 State 16848 16848 0

Vaccination operations 27 State/Farmers 25272 13204 12068

Monthly visits for active

surveillance 8 State 7488 7488 0

Active surveillance analyses 17 State 15912 15912 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 lies in better implementation, including digitalisation,

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

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.

59

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 External study, p.131. 52 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.

60

identified issues are primarily implementation-related or reflects evolving

epidemiological needs rather than stemming from deficiencies in the design of the

framework.

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 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on

veterinary medicinal products and repealing Directive 2001/82/EC,

http://data.europa.eu/eli/reg/2019/6/oj. 54 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022

on serious cross-border threats to health and repealing Decision No 1082/2013/EU, http://data.europa.eu/eli/reg/2022/2371/oj.

55 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. 56 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

61

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

disease-specific frameworks, in particular Regulation (EC) No 999/200157 on

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. 57 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. 58 External study, Annex 3, p. CXXXVIII.

62

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

63

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.

64

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

65

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 External study, Annex 3, p. CCLIV. 61 External study, Annex 3, p VIII.

66

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 External study, Annex 3, p V. 63 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.

67

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

68

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 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. 65 External study, p. 145.

69

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 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.

67 External study, Annex 3, p. 146.

70

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

71

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. Its continued effectiveness depends on remaining responsive to

epidemiological risks, including emerging, vector-borne and wildlife-related diseases,

and to different regional contexts.

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.

72

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.

73

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.

74

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.

75

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.

76

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

Effectiveness

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Effectiveness

Effi 1.1 What

were the main

challenges in the

implementing

phase after April

2021? To what

extent have these

been addressed?

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

AHL after its

1.1.1 Level of alignment of

national legislation to AHL

across MS

1.1.2 Identification of

challenges in the

implementation of AHL in

Member States

1.1.3-4 Measures taken at

EU level

1.1.1 Number of Member

States that have fully aligned

their national legislation

- MSs

reports

Member States were largely able to

align their national legislation with

the AHL within the required

timeframe, contributing to a more

harmonised framework. However,

the extent and approach varied:

some consolidated existing

legislation into the new framework,

while others repealed and replaced

national rules. Differences in

alignment reflect varying

administrative capacity and legal

traditions.

Key challenges included the

complexity of the framework,

uneven clarity of certain provisions,

limited administrative and

veterinary resources, and

differences in national

interpretation. Practical issues also

arose from gaps in digital systems,

workforce constraints, and partial

implementation of obligations such

1.1.1 Number of Member

States that have partially

aligned their national

legislation

- MSs

reports

1.1.1 Number of Member

States that have not aligned

their national legislation

- MSs

reports

1.1.1 Degree of significance

of the lack of adaptation - Audit

reports

1.1.1 Type of alignment

carried out by MS - MSs

reports

1.1.1 Timing of legislative

adaptation - Annual

reports

1.1.2 Challenges identified by

stakeholders that affect the

implementation of the AHL at

national level

- Audit

reports

77

Evaluation

Question Sub question Judgement criteria Indicators Data sources

entry into force?

(e.g. complexity

of the

regulations; lack

of clarity ;

insufficient

resources,

resistance from

stakeholders,

lack of

coordination)

1.1.3 How and to

which extent

were challenges

addressed at the

EU level?

1.1.4 How and to

which extent

were those

challenges

addressed at

national level?

1.1.2 Types of challenges

identified by stakeholders

(uneven starting point,

regulatory, administrative,

financial, technical, cultural,

etc.)

- MSs

reports

- Audit

reports

as biosecurity, animal health visits,

and contingency planning.

At EU level, challenges were

addressed through guidance,

coordination mechanisms, and

digital tools such as ADIS and

TRACES, which improved

surveillance, notification, and data

exchange. The AHL itself

strengthened legal clarity, defined

responsibilities, and introduced

structured approaches to disease

management, supporting more

coordinated implementation.

At national level, Member States

addressed challenges through

legislative adjustments,

administrative measures, and

gradual strengthening of

implementation systems. However,

progress remains uneven, with

continued differences in

enforcement, resource allocation,

and system capacity affecting the

full and consistent application of

the AHL

External study, p. 52

1.1.2 The size and structure of

MS affect the implementation

of AHL

- Audit

reports

1.1.3 Measures taken at the

EU level to address identified

challenges (Number of

Implementing Acts/Delegated

Acts)/and the amendments to

these Acts

- Eu

legislation

changes

EU

website

1.1.3 Timing of Adoption of

tertiary legislations - Audit

reports

1.1.3 Evidence of adequate

and regular training sessions

organised

- Annual

reports

- Audit

reports

1.1.3 Best practices shared

1.1.4 Measures taken at

national level to address

identified challenges (e.g.

establishment of Task force,

Committee, training session)

- Ms reports

- Audit

reports

78

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Effe 1.2 To what

extent has the

AHL legislation

achieved its

general and

specific

objectives?

1.2.1 What

progress has been

made towards the

achievement of

the general

objective of

preventing and

controlling

animal diseases

transmissible to

animals or

humans by:

- ensuring

improved animal

health to support

sustainable

agricultural and

aquaculture

production

[Art.1(2.a.i)]

- ensuring the

effective

functioning of the

internal market

for the livestock

and aquaculture

sector and other

1.2.1.1 Evidence of

progress towards the

general objectives

1.2.1.2 The AHL is

effective in preventing and

controlling animal diseases

1.2.1.3 Stakeholder

perception on the AHL

contribution to the

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

effectiveness of training

programmes focused on

animal health and

sustainable practices

1.2.1.6 Stability,

competitiveness, growth of

livestock and aquaculture

market

1.2.1.7 Evidence of no

significant disruptions in

the Internal market

1.2.1.1 Stakeholder views on

the reasons for (un)success in

achieving the general

objective

- Input

during

PAFF and

other

meetings

by

stakehold

ers

The AHL has made clear progress

towards achieving its general and

specific objectives by establishing a

harmonised and prevention-

oriented framework, improving

disease control, and supporting

trade through tools such as

regionalisation and traceability. It

has also simplified the legal

framework and introduced a

flexible, risk-based approach to

emerging diseases.

However, its full effectiveness is

not yet realised due to uneven

implementation, complexity in

practice, and the early stage of

application, which limits a

complete assessment of outcomes.

External study p 60

1.2.1.1 Number of areas

declared disease-free

following to the

implementation of eradication

programmes

- 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

1.2.1.1 Change in the number

and quality of animal health

visits from veterinarians

[Art.25] since the

introduction of AHL

- Audit

reports

79

Evaluation

Question Sub question Judgement criteria Indicators Data sources

kept animals

[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]

- Audit

reports

1.2.1.2 Appropriate

(preventive) measures are

undertaken for movements of

kept animals [Art124-169;

191-225; 244-251]

- Audit

reports

1.2.1.2.2-3 The

availability/number of

veterinarians carrying out

regular visits is deemed

suitable by stakeholders

- Audit

reports

1.2.1.2 The frequency of

health visits is deemed

suitable by stakeholders

- Audit

reports

- FVE

report on

art. 25

1.2.1.1 Number and quality of

contingency plans and

simulation exercises

conducted [Art.43;45]

- MS

reports

- Audit

reports

80

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]

- MS

reports

- Audit

reports

1.2.1.5 Strengthened

competitiveness of farming

and the rural economy (I) - Interviews

1.2.1.6 Market data (volumes,

prices, trade flows) are

maintained or increased

- Desk

research:

Comext

database

and

Eurostat

- Focus

groups

(Question

s on

potential

benefits

for trade

due to

AHL

introducti

on)

81

Evaluation

Question Sub question Judgement criteria Indicators Data sources

1.2.1.6 Trade flows are

maintained and undisrupted

- Desk

research:

Comext

database

and

Eurostat

- Focus

groups

(Question

s on

potential

benefits

for trade

due to

AHL

introducti

on)

1.2.2 To which

extent did the

AHL achieve its

specific objective

of establishing a

single,

simplified,

transparent and

clear regulatory

framework by

providing a clear

and balanced

distribution of

1.2.2.1 There is adequate

clarity across actors

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

introduced simplified

procedures

1.2.2.4 The regulatory

framework reduces

complexity and

1.2.2.2.1-2 Stakeholders’

views regarding clarity and

benefit of the role and

responsibilities outlined by

the AHL

- Survey

1.2.2.3 Stakeholder views on

the new rules and procedures

introduced by the AHL - Survey

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

82

Evaluation

Question Sub question Judgement criteria Indicators Data sources

roles and

responsibilities

and introducing

simplified

procedures?

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)

- Interviews

with

internatio

nal

organisati

ons

1.2.2.5 Existing and well-

functioning online

information system to register

and document the evolution of

diseases [Art.22] (O)

- Desk

research:

disease

notificatio

n systems

and audit

reports

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)

- Disease

notificatio

n systems

and audit

reports

1.2.2.5 Protocols have been

developed to ensure effective

and rapid emergency

measures in cases of outbreak

or hazard [Art. 257-262] (O)

- Disease

notificatio

n systems

and audit

reports

1.2.2.5 Existing and well-

functioning online

information system to track

animal movements

- Traces

valuation

83

Evaluation

Question Sub question Judgement criteria Indicators Data sources

1.2.3.6 Degree of

coordination between

veterinary and human health

authorities

1.2.4 To which

extent did the

AHL achieve its

specific objective

of ensuring

consistency

among principles

of animal health,

animal welfare

and food safety

legislation?

1.2.4.1 The AHL ensures,

through its principles,

consistency with the

principle of animal welfare

1.2.4.2 The AHL ensures,

through its principles,

consistency with the

principle of food safety

1.2.4.3 The AHL ensures,

through its principles,

consistency with the

principle of One Health

1.2.4.1-3 Coherence with food

safety, animal welfare, One

Health regulation and wider

strategic policy objectives

- Surveys

- Findings

from EQ

coherence

- Interviews

- Case

studies

1.2.5 To which

extent did the

AHL achieve its

specific objective

of reducing the

socio-economic

impact of animal

diseases on

public health,

animal welfare,

economy and

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)

- ADIS

1.2.5.1.4 Stakeholders' views

on the social impact of AHL

- Surveys

1.2.5.2.1 Improved public

perception of animal health

- Call for

Evidence

- Interviews

84

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 by the

implementation of the AHL

1.2.5.2.2 Reduction of animal

health disparities across socio-

economic groups (MS eastern

versus western/ Farmers small

versus bigger)

- Interviews

- Focus

groups

1.2.5.2.3 Reduction of animal

health disparities across socio-

economic groups (MS eastern

versus western/ Farmers small

versus bigger)

- Case

studies

1..2.5.2.4 Risks of

interference with the internal

market due to animal disease

are minimised ( R)

- Surveys

1.2.5.2.5 Trade flows are

maintained without

significant disruptions.

- Desk

research:

Comext

database

Effe 1.3 How do

these results

compare with the

initial

expectations?

1.3.1 Has the

AHL led to an

improvement in

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

1.3.1 Number of outbreaks of

listed disease - : Adis

The results of the AHL broadly

align with initial expectations. It

has delivered a flexible, coherent,

and risk-based framework,

supporting prevention, improved

coordination, and internal market

stability. The shift towards a

proactive approach has

1.3.1 Trade of live animals

and animal products to 3rd

countries

- Desk

research:

Comext

database

1.3.2. Stakeholders' view on

results alignment with initial

expectations

- Call for

Evidence

85

Evaluation

Question Sub question Judgement criteria Indicators Data sources

to the

expectations set

forth in the

Impact

Assessment and

the Animal

Health Strategy

2007-2012, as

well as in the

legislation?

1.3.3 Is the One

Health principle

reflected in the

national

legislation related

to animal health?

1.3.3 National legislation

reflects the One Health

approach in their legislation

related to animal health

1.3.3 Stakeholders' view

regarding AHL contribution

to the one health approach

- Surveys

(Q33 on

coherence)

strengthened preparedness and

response capacities.

However, implementation has been

more complex than anticipated,

with delays and inconsistencies in

aligning national legislation across

Member States.

External study , p 82

Effe 1.4 What are

the strengths and

weaknesses of the

AHL, in particular

in relation to

specific

provisions,

regarding:

1.4.1 Does the

AHL clearly

outline the roles

and

responsibilities

across different

actors involved in

animal health?

1.4.1 Roles and

responsibilities for actors,

e.g. competent authorities

and stakeholders, are

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

- Interviews

The AHL’s key strengths

include clearer roles and

responsibilities across

stakeholders, improved

coordination, and a strong risk-

based approach enabling

targeted EU intervention

through tools such as disease

categorisation and

1.4.2 Stakeholders' views on

the priorities for the EU

intervention and limiting

factors are clearly outlined in

the AHL

- Surveys

(linked to

external

coherence)

86

Evaluation

Question Sub question Judgement criteria Indicators Data sources

- clearer

responsibilities

- Priorities for EU

intervention

- prevention,

including

biosecurity and

surveillance?

1.4.2 Is the link

with EU

priorities clearly

set in the AHL?

1.4.3 Are there

any limiting

factors in linking

the AHL to the

wider EU

priorities?

1.4.4 Has

prevention,

including

biosecurity and

surveillance,

improved in the

EU since the

adoption of the

AHL?

intervention logic are

clearly set in the AHL text

1.4.3 Limiting factors that

could hamper the

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

1.4.3 Stakeholders' views on

the priorities for the EU

intervention and limiting

factors are clearly outlined in

the AHL

- Surveys

(linked to

external

coherence

)

regionalisation. It has

strengthened prevention,

particularly through

biosecurity and surveillance,

and modernised the legal

framework, supporting

measures like vaccination and

maintaining trade during

outbreaks.

However, weaknesses remain

in uneven implementation,

limited stakeholder

engagement, and gaps in

communication. Biosecurity

and prevention measures are

not consistently applied across

sectors and Member States,

with particular challenges for

small-scale operators. In

addition, capacity constraints

and limited expertise in

applying risk-based

approaches reduce overall

effectiveness.

External study, p.83

1.4.4 Qualitative description

of the action MS take to

increase biosecurity,

including enforcement

measures

- Annual

reports

- Audit

reports

1.4.4 Qualitative description

of the action MS take to

increase surveillance incl.

enforcement measures

- Annual

reports

- Audit

reports

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

- Interviews

1.4.4 Number of outbreaks of

contagious livestock disease - ADIS

1.4.4 Number of training

sessions taken up by animal

keepers, especially farmers

- Annual

reports

1.4.4 (Stakeholders views on)

the reaction time - Interviews

87

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Effe 1.5 What are

the main

shortcomings that

need to be

addressed?

1.5.1 Are there

any shortcomings

that can arise

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

1.5.1 Examples of

shortcomings identifiable that

can be linked to the

functioning of the AHL at EU

level

- Case

studies

The main shortcomings relate

to insufficient support and

guidance for farmers in

applying biosecurity and

disease detection measures, as

well as uneven implementation

of training and awareness

programmes across Member

States. Stakeholders also

highlight the lack of adequate

funding mechanisms and

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

fully distinguish structural

shortcomings from transitional

implementation challenges.

External study , p 89

1.5.1 Stakeholder views on

possible shortcomings linked

to the implementation of the

AHL at EU level

- Case

studies

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

1.5.1 Example of

shortcomings identified by

MS at national level during

outbreaks of contagious

livestock diseases

- Case

studies

1.5.1 Stakeholder views on

possible shortcomings linked

to the implementation of the

AHL at national level

- Case

studies

88

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Effe 1.6 To what

extent do the

AHL’s risk-based

approaches

effectively

prioritise

resources and

actions based on

the severity and

likelihood of

different threats?

Idem to EQ

1.6.1 The AHL’s risk-based

approaches effectively

prioritise resources and

actions based on the

severity and likelihood of

different threats

1.6.1 Stakeholders’ views on

the AHL’s risk-based

approaches effectively

prioritise resources and

actions based on the severity

and likelihood of different

threats

- Case

studies

The AHL’s risk-based approach is

generally effective in prioritising

resources and actions, allowing

tailored and 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, particularly for

persistent and emerging diseases.

Overall effectiveness remains

difficult to fully assess due to

ongoing and uneven

implementation across Member

States.

External study p 92

Effe 1.7 Does the

AHL enhance

transparency in

decision-making

processes related

to animal health?

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

in terms of more deeper

involvement of stakeholders .

Extrenal study p 94

89

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Effe 1.8 Does the

AHL enhance the

resilience of

animal health

systems?

Idem to EQ

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

- Interviews

The AHL has enhanced the EU's

capacity to detect, contain, and

respond to outbreaks through

structured mechanisms like zoning,

regionalisation, and traceability.

These tools allow for targeted

restrictions rather than blanket

bans, helping maintain internal

market stability even during disease

events.

Stakeholders acknowledged the

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

1.8.2 The AHL has a

positive effect on the

competitiveness of the EU

agri-food sector in the face

of changing environmental,

social and economic

conditions

1.8.2 Stakeholder views on

the impact of the AHL on the

competitiveness of the EU

agri-food sector

- Interviews

1.8.2 Data and statistics linked

to the competitiveness of the

EU agri-food sector

- Desk

research:

Comext

database

- Inputs

from other

EQs

1.8.2 Intra-EU trade and trade

with 3rd countries

- Desk

research:

Comext

database

- Inputs

from other

EQs

Effe 1.9 What

were the

unexpected or

unintended effects

Idem to EQ

1.9 Stakeholders examples

of unexpected or

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

90

Evaluation

Question Sub question Judgement criteria Indicators Data sources

which have

occurred during

implementation?

from the implementation of

the AHL

1.9 Stakeholders examples of

the impacts of such

occurrences

addition, tools such as

regionalisation are not always

applied or recognised consistently

between Member States, reducing

their effectiveness and affecting

confidence in 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

91

Efficiency

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Efficiency

Effi 2.1 Has the

implementation

of the AHL

generated

incremental costs

and benefits for

different

stakeholders?

Are the costs

proportionate to

the benefits of the

AHL?

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 and

aquaculture

farmers, animal

farming and

industry

operators,

veterinarians, and

competent

authorities of

major trading

partners) versus

baseline scenario

(pre-AHL) for all

key activities?

2.1.2 Are

incremental

2.1.1. Assessment of

incremental costs and

benefits per each

stakeholder group

2.1.1 (direct and indirect)

incremental Costs for

operators (livestock and

aquaculture farmers, animal

farming and industry

representatives):

• cost of

implementing

biosecurity

measures to

prevent and control

disease

• costs of traceability

systems for animal

and animal

products and for

complying with

animal movements

• costs of

implementing

emergency

measures in case of

outbreaks

• costs for training

and education

- Surveys

- Interviews

- Desk research

The AHL has increased short-

term costs (e.g. administration,

training, biosecurity, reporting),

while benefits are mainly

structural and preventive—

improved coordination, clearer

responsibilities, and better

preparedness—and remain

difficult to quantify.

It is not yet clear that benefits

outweigh costs. Perceptions are

mixed: farmers and industry

often see higher costs, while

NCAs and veterinarians report a

more balanced view, and

academia is more positive.

Overall, the AHL shows potential

for benefits to outweigh costs in

the medium to long term,

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.

92

Evaluation

Question Sub question Judgement criteria Indicators Data sources

benefits larger

than the

incremental

costs?

2.1.1 (Direct and indirect)

Costs for veterinarians:

• costs of training

and education

• cost of

implementing new

technologies for

health surveillance

• costs and admin

burdens for

cooperation and

communication

activities

- Surveys

- Interviews

External study p. 98

2.1.1 Costs for NCAs:

• costs for

compliance and

reporting

• costs of

harmonization and

coordination

• cost for crisis

management in

case of outbreaks

- Surveys

- Interviews

93

Evaluation

Question Sub question Judgement criteria Indicators Data sources

2.1.1 Costs for EU officials:

• costs and resources

for data

maintenance

• regulatory and

oversight costs

• Cost for training

• Developing and

amending

delegated acts

- Surveys

- Interviews

2.1.1 (Indirect) Cost for the

public:

• consumer and

production costs

- Surveys

- Interviews

94

2.1.2 The benefits outweigh

the costs/stakeholders

consider the benefits to

outweigh the costs

2.1.2 Benefits for operators

(livestock and aquaculture

farmers representatives and

animal farming & industry

representatives (SMEs)

• benefits from

clearer rules and

responsibilities

• benefits from

market

opportunities for

preventive

measures or

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 animals and

trade

- Surveys

- Interviews

2.1.2 Benefits for NCAs: - Surveys

95

Evaluation

Question Sub question Judgement criteria Indicators Data sources

• benefits from

harmonisation and

coordination

• benefits from

clearer roles and

responsibilities

- Interviews

2.1.2 Benefits for the public:

• benefits from

improved human

and animal health

- Surveys

- Interviews

2.1.2 Cost-benefit ratio - Surveys

- Interviews

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 as

expected?

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 (total and

distribution between

stakeholders) - see 2.1.1.1-5

- Interviews

Costs are not yet distributed as

initially expected, though this is

largely perception-based and

reflects early AHL

implementation. They 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.

2.2.2 Were the

benefits

distributed

among

stakeholders as

expected?

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

2.2.3 What is the

magnitude of

incurred costs

and benefits for

stakeholders?

96

Evaluation

Question Sub question Judgement criteria Indicators Data sources

2.2.4 Are there

significant

differences in

terms of costs and

benefits between

MS?

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

Effi 2.3 Are there

additional

regulatory

burdens and/or

savings

stemming from

the

implementation

of the AHL?

What elements of

the legislation

generate

administrative

burden and/or are

overly complex?

2.3.1 Are there

additional

regulatory

burdens and/or

savings stemming

from the

implementation

of the AHL?

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 to enhanced

transparency

2.3.1 List of additional

regulatory burdens and/or

savings identified at MS

level

- Case studies

The AHL has generated

additional regulatory burdens,

particularly in the short term, as

stakeholders must navigate

multiple new EU rules and their

links with national legislation,

creating complexity 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

2.3.2 What

elements of the

legislation

generate

administrative

burden and/or are

overly complex?

2.3.2 Stakeholders’

perception of admin burden

and/or savings - Case studies

Effi 2.4 Have any

inefficiencies

been identified?

How do these

Idem EQ

2.4.1 Inefficiencies

identified in relation to

challenges identified as per

EQ #1.2

2.4.1 Stakeholder opinions,

or policy research notes on

major inefficiencies

(administrative, operational,

etc.)

- Interviews

Some inefficiencies have been

identified, mainly in the early

implementation phase. NCAs

faced challenges registering new

operators, farmers report added

97

Evaluation

Question Sub question Judgement criteria Indicators Data sources

impact different

stakeholders?

2.4.2 Stakeholders identify

inefficiencies and their

impact

2.4.2 Stakeholder perception

of inefficiencies - Interviews

costs with unclear short-term

benefits, delays occur in

certification processes, and

veterinarians face 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

Effi 2.5 What

reporting

obligations stem

from the

regulation? Is

there potential for

simplification

and cost

reduction, for

example through

rationalisation,

benefiting

businesses and

competent

authorities?

Idem EQ

2.5.1 Available

opportunities for

simplification and

cost/burden without

hampering effectiveness

2.2.1 See inputs from 2.1.1 - Inputs from

other EQs

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.

There is potential for

simplification through better

alignment, greater use of

flexibility, and improved

digitalisation (e.g. TRACES,

interoperability). Preventive

measures are considered cost-

effective.

External study, p.127

2.5.1 Stakeholder opinion

on the opportunities for

simplification and

cost/burden reduction

- Interviews

98

Coherence

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Coherence

C 3.1 To what

extent is the

legislation

coherent within

itself? Have the

different

elements of the

legislation

operated together

to achieve all the

objectives of the

legislation in a

coherent way?

3.1.1 To what

extent the

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

delegated and

implementing

acts adopted so

far?

3.1.1 Existence of diverging

interpretations and/or

application issues regarding

AHL provisions

3.1.2 Existence of

inconsistent or

contradictory provisions

between the AHL and its

delegated and

implementing acts

3.1.1 Number of diverging

provisions, interpretations

and/or application issues

regarding AHL provisions

- Surveys

- Interviews

- Desk

research:

legislative

texts and

case-law

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

stem from differences in

interpretation and

implementation across Member

States rather than 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 extent to which these

objectives are fully achieved in

practice.

The AHL is broadly coherent

with its Delegated and

Implementing Acts, forming a

consistent and integrated legal

framework, while some targeted

technical clarifications could

further enhance legal clarity and

operational effectiveness.

External study, p.131

3.1.2 Number of inconsistent

or contradictory provisions

between the AHL and its

delegated and implementing

acts

- Interviews

- Desk

research:

legislative

texts and

case-law

- Call for

Evidence

99

Evaluation

Question Sub question Judgement criteria Indicators Data sources

C 3.2 Is this

legislation

coherent with

other related EU

pieces of

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

diverging provisions,

interpretations and/or

application issues between

the legislations considered

3.2.8 Degree to which the

AHL allowed making

proper use of EU financing

3.2.1-3.2.7 Number of

diverging provisions,

interpretations and/or

application issues

- Surveys

- Desk

research:

- Literature

- EC

legislative

documents

- General

Food Law

- Case-law

- Call for

Evidence

- Case Studies

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 rules is generally

satisfactory.

Coherence is moderate with

animal welfare legislation and EU

financing instruments, where

further alignment is needed. No

major contradictions are

identified; remaining issues are

mainly operational, linked to

100

medicinal

products and

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

3.2.8 Number of cases in

which the AHL prevented or

hindered the proper and

timely earmarking of EU

financing

- Interviews

implementation differences

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

101

Evaluation

Question Sub question Judgement criteria Indicators Data sources

3.2.7 To what

extent is the AHL

and its principles

(risk based and

new scientific

Knowledge)

coherent with

other legislation

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

animal health

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

provisions, interpretations

and/or application issues

between AHL and MS

animal health measures

3.3.2 Number of diverging

provisions, interpretations

and/or application issues

- Surveys

- Interviews

- Desk research

The AHL has established a

coherent EU-level framework,

but its implementation remains

uneven across Member States due

to different legal systems,

capacities, and starting points.

While some countries adapted

102

Evaluation

Question Sub question Judgement criteria Indicators Data sources

policy within the

EU and in the

territory of the

Member States?

Did the

implementation

of the AHL

reveal any

incoherent

elements

internally or

externally, in

particular with

national animal

health measures

and systems?

that usefully

complements

animal health

policy and

legislation

developed by

MS?

3.3.2 To what

extent the

provisions of the

AHL and other

relevant EU

legislation have

been interpreted

and/or applied in

a way that

usefully

complements

animal health

policy and

legislation

developed by

MS?

3.3.2. Existence of

diverging provisions,

interpretations and/or

application issues between

AHL, other relevant EU

legislation and MS animal

health measures

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

interpretation and ongoing

national adaptation affect

consistency.

Overall, coherence is progressing

but not yet fully realised, as

implementation is still ongoing

across Member States. External

study, p.135.

C 3.4 To what

extent does the

AHL facilitate

3.4.1 To what

extent has the

AHL been

3.4.1 Degree to which the

AHL is perceived as an

effective instrument to

3.4.1 Stakeholders opinion - Interviews

The AHL is generally recognised

as a strong framework for

addressing global animal health

103

Evaluation

Question Sub question Judgement criteria Indicators Data sources

international

collaboration on

animal health to

address global

challenges and

promote

harmonisation of

standards?

recognised as an

effective model

of regional

governance in the

animal health

area?

3.4.2 To what

extent has the

AHL inspired the

legislators of

other

jurisdictions

outside the EU?

3.4.3 To what

extent has the

AHL raised

concerns from the

EU’s trading

partners?

tackle animal health and

related challenges beyond

national borders

3.4.2 Degree to which the

AHL has promoted

harmonisation of animal

health standards outside the

EU

3.4.3 Existence of SPS

concerns about the AHL at

the WTO level

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 alignment in

neighbouring countries and in

export-oriented sectors seeking

access to the EU market.

However, its influence beyond

the EU remains moderate, as

uptake by third countries is

uneven and broader

harmonisation of standards is

limited. While no major concerns

from trading partners are

consistently reported, the AHL’s

complexity and specific

requirements can pose challenges

for external alignment.

External study, p.137

3.4.3 Number of SPS

concerns about the AHL still

open at the WTO level

- Desk research

- Interviews

C 3.5 To what

extent does the

AHL promote

cooperation with

relevant

international

organisations, the

exchange of

3.5.1 To what

extent has the

implementation

of the AHL

fostered

cooperation in

relevant

international

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

exchange of information

3.5.1 Stakeholder perception

on the degree to which AHL

promotes cooperation - Interviews

The AHL has strengthened the

EU’s role in international

cooperation, particularly within

organisations such as World

Organisation for Animal Health,

and has supported improved

information exchange on

transboundary animal diseases,

3.5.1. Examples of

cooperation in the context of

AHL implementation - Interviews

104

Evaluation

Question Sub question Judgement criteria Indicators Data sources

information and

joint response

measures?

organisations

(e.g.,

WOAH/OIE)?

3.5.2 To what

extent has the

implementation

of the AHL

catered for the

exchange of

information and

joint response

measures in the

context of

relevant

international

organisations

(e.g. through

WAHIS)?

and joint response measures

at the international level

3.5.2 Number of cases where

exchange of information and

joint response measures in

relation to cross-border

threats to animal health took

place under the AHL

framework

- Interviews

including through systems like

World Animal Health

Information System.

Its contribution is mainly indirect,

driven by EU engagement in

international fora and trade-

related objectives. While it

facilitates cooperation and

information sharing, further

efforts in awareness-raising and

technical support could enhance

its visibility and uptake among

international partners.

External study, p.140

C 3.6 To what

extent does the

intervention

comply with the

‘do no significant

harm’ principle?

3.6.1 To what

extent is the AHL

coherent with the

EU efforts to

fight climate

change?

3.6.2 To what

extent is the AHL

coherent with EU

policies that

3.6.1. Degree of alignment

between AHL and EU

efforts to fight climate

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)

3.6.1 Evidence collected

from literature and

stakeholders

- 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 economy, and

environmental sustainability.

3.6.2 Evidence collected

from literature and

stakeholders

- Interviews

(with NGO

and

science/acade

mia)

105

Evaluation

Question Sub question Judgement criteria Indicators Data sources

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 and

unsustainable

management of

water and marine

resources?

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

3.6.3 Evidence collected

from literature and

stakeholders

- Interviews

(with NGO

and

science/acade

mia )

The AHL contributes positively

to biodiversity protection through

disease prevention, including in

wildlife. However, certain

measures, such as culling for

disease control, may at times

conflict with conservation and

rewilding objectives.

Overall, coherence with

environmental policies is partial

and indirect, and the assessment is

constrained by limited

stakeholder feedback on these

aspects. External study, p.142 3.6.4 Evidence collected

from literature and

stakeholders

- Interviews

(with NGO

and

science/acade

mia)

106

C 3.7 To what

extent is the

intervention

coherent with the

EU sustainable

development

goals? How does

the AHL relate to

and contribute to

strategic policy

objectives,

among others

One Health,

Green Deal, a

Long-Term

Vision for Rural

Areas and the

sustainable

competitiveness

of the agri-food

sector? In

particular, does

the AHL

strengthen the

integration of a

One Health

approach that

recognises the

interconnectedne

ss of human,

animal, and

3.7.1 To what

extent does the

AHL contribute

to the objectives

of the EU Green

Deal and the

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

extent does the

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 and Long-Term

Vision for Rural Areas

3.7.4. Degree of alignment

between the objectives of

AHL and current and

emerging EU policies on

long-term competitiveness

of the EU agri-food sector

3.7.1-of 4 Evidence collected

from literature and

stakeholders, namely on

social, economic and

environmental dimensions.

- Surveys

- Desk research

- Interviews

The AHL is broadly aligned with

key EU policy frameworks,

including the Green Deal, Farm to

Fork Strategy, One Health

approach, and the Long-Term

Vision for Rural Areas. It

supports the internal market by

harmonising animal health rules

and enabling safe animal

movements, thereby contributing

to the competitiveness of the EU

agri-food sector.

The AHL reflects a clear

commitment to the One Health

approach by integrating animal,

human, and, to a lesser extent,

environmental health

considerations. However, its

practical implementation and

cross-sectoral integration are still

evolving.

Stakeholder perceptions vary:

civil society and academia see a

strong contribution, while

veterinarians, NCAs, farmers,

and industry consider it more

moderate due to ongoing

implementation challenges.

External study, p.143

107

Evaluation

Question Sub question Judgement criteria Indicators Data sources

environmental

health?

108

Relevance

Evaluation

Question Sub question Judgement criteria Indicators Data sources

Relevance

R 4.1 To what

extent is the AHL

fit and relevant to

current and

emerging needs

regarding Animal

health?

4.1.1 Is

implementation

of the AHL

harmonised and

streamlined

across MSs?

4.1.2 Are the

responsibilities of

stakeholders

(farmers,

veterinarians, MS

competent

authorities, and

others) still up to

date with current

needs?

4.1.1 Stakeholders

perceive a more

harmonised approach

4.1.2 Delineation of roles

and duties of relevant

stakeholders is clear

4.1.3 The availability and

offer of trainings for

veterinarians, animal

handlers, and staff is

adequate

4.1.4 Criteria to address

emerging diseases are in

place

4.1.1 Degree of agreement of

stakeholders on the level of

harmonisation - Surveys

The AHL is overall fit and

relevant to current and emerging

animal health needs, providing a

harmonised and adaptable

framework that supports disease

control, facilitates trade, and

ensures a level playing field

across Member States. The

disease listing and categorisation

system is considered a clear

improvement and remains

appropriate to current challenges.

The AHL also broadly defines

stakeholder responsibilities and

supports training (e.g. through

BTSF), although dissemination to

operators remains uneven,

leading to gaps in awareness.

4.1.2 Degree of understanding

and agreement in roles and

responsibilities of relevant

stakeholders among MS

- Surveys

4.1.3 Proportion of

veterinarians, animal handlers

and staff involved with animal

health and biosecurity

ve acquired knowledge

through formal education or

training regarding animal

health, disease prevention and

their responsibility

- Interviews

- Case studies

- Desk

research:

FVE reports

on art. 25

109

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?

4.1.4 Are the

criteria for listing

of diseases still

up to date with

current needs?

4.1.4 Diseases that cannot be

adequately listed

- Interviews

- Case studies

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

in responses to vector-borne

diseases. In addition, limited

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

R 4.2 To what

extent is the AHL

able to adapt and

adequately reply

to evolving

threats and

challenges in

animal health?

4.2.1 Are there

examples where

AHL, DA or IA

have adopted new

diseases

(including new

threats and

emerging

diseases)?

4.2.1 Degree of

responsiveness of the

legislation in including

new animal diseases

4.2.2

Stakeholders/scientific

experts agree with the

criteria of categorisation

and prioritisation of

animal diseases

4.2.12 Incorporation of

zoonosis, new emerging

animal diseases in AHL, DA

or IA

- Focus group:

academia and

NCAs

The AHL is largely able to adapt

to evolving animal health threats

through its harmonised and

flexible framework, with

appropriate disease categorisation

and the ability to address new and

emerging diseases. Systems like

ADIS support monitoring and

information exchange.

4.2.3 Number of large-scale

disease outbreaks and of

animals culled due to

eradication measures

- Focus group:

academia and

NCAs

110

Evaluation

Question Sub question Judgement criteria Indicators Data sources

4.2.2 Does the

AHL currently

consistently

cover all diseases

(including

zoonosis, new

food safety

threats and

emerging

diseases)?

4.2.3 Are the

animal diseases

categorised and

prioritised

correctly?

4.2.4 Is the

Animal Disease

Information

System (ADIS)

adaptable to

emerging

diseases?

4.2.3 Degree of

responsiveness of ADIS in

including new animal

diseases

4.2.4 Stakeholders'

opinion/proposal on criteria

for categorisation and

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

R 4.3 Are there

issues that arose

after the adoption

of the Regulation

4.3.1 How well

adapted is the

AHL to:

4.3.1 Adequacy of

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

require further attention.

Flexibility in addressing fast-

spreading diseases has led to

111

Evaluation

Question Sub question Judgement criteria Indicators Data sources

that would

require further

attention in view

of the objectives

pursued?

- The

animal

health

situation

that

occurred

after

2021?

- The

effective

function

ing of

be included in the AHL,

including DA and IA

4.3.1 Adequacy of the

AHL to support the

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

that necessitate EU-level

action perceived by

stakeholders

- Interviews

- Focus groups

divergent national approaches

and trade disruptions. While the

AHL worked broadly as expected

in crises (e.g bluetongue), gaps

remain, including uneven

biosecurity improvements across

sectors and burdensome

notification requirements in

urgent situations., External study

p.156

4.3.1 Reduction of adverse

effects on animal health,

public health and the

environment due to

inadequate EU legislation

- Interviews

- Focus groups

112

Evaluation

Question Sub question Judgement criteria Indicators Data sources

the

internal

market?

- Reducti

on in the

adverse

effects

on

animal

health,

public

health

and the

environ

ment?

4.3.2 How well

adapted is the

AHL to

technological

developments

that have

appeared since its

introduction?

4. 3.2 Adequacy of the

AHL incl. DA and IA to

implement new

technological

developments that have

appeared since its

introduction

4.3.2 Evidence of the

implementation technological

developments, e.g. updates of

TRACES, data collection

methods, digitalisation,

detection methods, vaccines,

transport

- Interviews

113

EU added value

Evaluation

Question Sub question Judgement criteria Indicators Data sources

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?

5.1.1 T What are

the major benefits

observed due to

the

implementation

of the AHL?

5.1.2. What are

the observed

positive and/or

negative impacts

of the AHL on

animal health and

trade?

5.1.3 Could the

same results have

been achieved by

national animal

5.1.1 Identifiable

evidence that the

AHL’s effects could

have been achieved

without EU

intervention

5.1.2. Observed

positive and negative

impact of AHL

5.1.3 Identifiable

evidence that Member

States acting alone met

equivalent results to the

ones of the AHL

5.1.1 Stakeholder opinion

on the extent to which the

effects of the AHL could

have been achieved without

EU intervention without

updating of the AHL

- Surveys

The AHL has clear EU added value by

strengthening coordination of animal

disease prevention and control across

Member States and 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.

5.1.2. Identified positive

and negative impacts of

AHL - Surveys

5.1.3 Stakeholder opinion

on the need for EU-level

coordination - Surveys

114

Evaluation

Question Sub question Judgement criteria Indicators Data sources

health measures

and system

alone?

5.1.4 To what

extent has the

AHL contributed

to coordination

for better animal

disease

5.1.4. Identified

differences in measures for

the prevention and control

of emerging and listed

diseases and sanitary

measures in kept terrestrial

and aquatic animal MS in

EU MS prior to the

implementation of the AHL

- Interviews

- Case studies

Overall, the AHL has enhanced

alignment and cooperation across the

EU, although some variation in

implementation persists, particularly

due to limited detail on biosecurity and

animal health visits, which are left to

national discretion. External study

p.158

115

prevention and

control measures

in EU MS?

5.1.5. Would

measures for the

prevention and

control of

emerging and

listed diseases in

kept terrestrial

and aquatic

animals be

differently

applied in EU MS

without AHL?

5.1.6 Could

measures for the

prevention and

control of

emerging and

listed diseases in

kept terrestrial

and aquatic

animals and

sanitary measures

in wild animals

be differently

applied in EU MS

without AHL?

5.1.5 Identified differences

in measures for the

prevention and control of

emerging and listed

diseases and sanitary

measures in wild animals in

EU MS prior to the

implementation of the

AHL

- Interviews

- Case studies

EUAV 5.2 To

what extent did

5.2.1 To what

extent does the

5.2.1 Degree of

responsiveness of the

5.2.1 Degree of

responsiveness of the - Interviews

The AHL strikes an overall

proportionate balance between EU-

116

Evaluation

Question Sub question Judgement criteria Indicators Data sources

this intervention

strike a balance

between action at

the EU level and

national action?

Is it

proportionate?

AHL provide

sufficient

flexibility to

adapt rules to

local

circumstances?

5.2.2 Are there

any

efficiency/effecti

veness gains of

EU-level action

compared to

national action?

legislation in including

new animal diseases

5.2.2 Identifiable

evidence that the AHL

ensures

efficiency/effectiveness

gains compared to

national actions

legislation in including new

animal diseases

level coordination and national action.

It provides a harmonised framework for

major diseases (categories A and B),

ensuring consistent measures across

Member States, while allowing

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 responses, improved

disease control, and support to the

internal market. However, for diseases

where flexibility is higher, different

national measures can lead to

inconsistencies, suggesting that in some

cases stronger EU-level coordination

could further improve uniformity.

External study p.161.

5.2.1 Stakeholder opinion

on the flexibility provided

by the AHL to adapt rules

to local circumstances

- Interviews

5.2.2 Identifiable evidence

that the AHL ensures

efficiency/effectiveness

gains compared to national

actions

- Inputs from

efficiency/eff

ectiveness

5.2.2 Stakeholder opinion

on efficiency/effectiveness

gains driven by the AHL

compared to national

actions

- Inputs from

efficiency/eff

ectiveness

117

Evaluation

Question Sub question Judgement criteria Indicators Data sources

EUAV 5.3 What

adaptations could

increase the

additionality of

EU-level action?

5.3.1 Can

adaptations be

identified that

may increase the

additionality of

EU-level action?

5.3.1 Suggestions for

improvements put

forward that justify

(further) EU-level

action

5.3.1 Stakeholder

suggestions for

improvements justifying

EU-level action

- Surveys

- Inputs from

previous

criteria

EU added value could be strengthened

through clearer and more structured

guidance to support more consistent

implementation across Member States,

including tailored, sector-specific

guidance to improve clarity and

compliance.

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

maintaining flexibility for local

conditions. External study p.163.

<Written by><Month – 20XX>

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:

Key area 1:

Prevention and

control of

transmissible animal

diseases;

Recurrent and

one-off:

Estimation of

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.

Indirect benefit:

Lower use of

antimicrobials

contributing to less

AMR

Indirect Cost:

Potentially a slight

increase in pricing of

goods.

Estimates are

that benefits of

healthy animals

far outweigh the

economic

impact. For

example, an

average pig

farmer earns

5.753.700 euro

per year, who

can face losing

profits

depending on

infected

animals. Profit

loses from death

of animals

affect profits:

ranging from

10% dead

Direct benefit:

Less risk of

diseases

destroying farms.

Indirect benefit:

Less farms

destroyed, more

products on

market giving

macroeconomic

benefits.

Additionally, less

environmental

impacts for

farmers if other

farms get sick.

Direct

compliance cost:

Adjustment to

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

less

administrative

works for

incidence.

Direct benefit:

Less

administrative

work from

disease

incidents due to

less

duplications.

119

animals

(575.370 euro)

to 90%

(5.178.330

euro) dead ones.

Animal deaths

are

unpredictable,

but loss of

animals far

outreach

administrative

burdens on

farmers, as

disease

outbreaks cause

financial ruin.

new

requirements.

Estimate slight

adjustment 5-

10%.

Enforcement

cost: Inspection

of animals health

are still

happening, no

cost change here.

Key area 2:

Prioritisation and

categorisation of

animal diseases of

Union concern

Recurrent:

Not applicable Farmers

indicate an

additional

burden on 5 to

10% extra,

depending on

their size. This

is offset by

quicker

identification of

animal diseases

that lowers risk

of further

Direct benefit:

Proportionate

measures to

prevent and

control animal

diseases, avoid

focussing on too

many diseases

Indirect benefit:

Common

knowledge on

diseases in

regions aids

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

Direct benefit:

Easier

administrative

work on

identification

Enforcement

cost:

Monitoring and

updating the

list. No cost

change due to

120

animal deaths

and infections.

better and

focussed earlier

treatment.

less

administrative

works for

incidence.

part of their

agencies work.

Key area 3: Animal

disease Surveillance,

early detection,

notification, and

laboratory

confirmation;

eradication

programmes and

disease–free status.

Recurrent and

one off:

Direct benefit:

Consumer knowing

product is disease-

free.

Indirect benefit: Not

becoming infected

from other people.

Estimation of a

5 – 10%

increase,

depending on

the size of the

farmer. This is

offset by

quicker

identification of

animal diseases

that lowers risk

of further

animal deaths

and infections.

Indirect benefit:

Label of “disease

free” status is

marketable.

Direct cost:

Implementation

fees (one off).

Enforcement

cost:

Surveillance,

testing, disease

control measures

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

less

administrative

works for

incidence.

Direct benefit:

Direct cost:

Implementation

fees (one off).

Enforcement

cost: Reaction

to notification,

and laboratory

confirmation of

diseases.

121

Key area 4:

Biosecurity and

responsibilities of

operators and

competent authorities

Recurrent:

Not applicable Farmers

indicate an

additional

burden on 5 to

10% extra,

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

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

less

administrative

works for

incidence.

Indirect

benefit:

Prevention of

introducing

harmful

organism

reduces

enforcement

cost through

less

notifications

and laboratory

checks.

Enforcement

cost: Actions

to minimize risk

of introduction

of harmful

organisms.

Key area 5: Disease

eradication,

awareness,

preparedness and

control

Recurrent:

Indirect benefit:

Awareness allows

consumer to make

better choices when

buying products.

Direct benefit:

Better farmer’s

awareness, easier

knowledge of

animal diseases

severity.

Indirect benefit:

Disease

eradication can

long term lead to

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

Indirect

benefit:

Disease

eradication can

long term lead

to better

competitiveness

on a

macroeconomic

scale.

122

less usage of

certain drugs.

population,

animals and

less

administrative

works for

incidence.

Key area 6:

Identification,

traceability, and

movements of

animals and germinal

products

Recurrent:

Indirect benefit:

Ensuring trust of

consumers when

buying products and

animals from

thrustful sources.

Direct benefit:

ensured

traceability of

animals less risk

of diseases

destroying farms.

Indirect benefit:

Ensuring trust in

national and

international

trade

Direct

compliance cost:

Adjustment to

new

requirements.

Enforcement

cost: Inspection

of animals health

are still

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

less

administrative

works for

incidence.

Enforcement

cost: Bigger

administrative

burden due to

new and

lengthier tasks.

123

happening, no

cost change here.

Key area 7:

Registration and

approval of

establishments and

operators.

One off:

Indirect benefit:

Ensuring trust of

consumers when

buying products and

animals from

thrustful sources

Farmers expect

slightly longer

registration and

approval.

Indirect benefit:

Ensuring trust in

national and

international

trade

Direct cost:

Applying to

register takes a

little time.

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

less

administrative

works for

incidence.

Enforcement

cost: Approval

of operators,

though already

a part of their

work.

124

Key area 8: Animal

health requirements

for movements in the

Union of terrestrial

and aquatic animals.

One-off /

Recurrent:

Not applicable Farmers expect

requirements to

move increases

burdens for 10-

15% of the cost.

Direct cost:

Filling out forms

to meet

requirement takes

a little time.

National

authorities

estimate an

increase in

10% burden

(on all total key

areas). This is

offset due to

the indirect

benefits such

as healthier

population,

animals and

less

administrative

works for

incidence.

Enforcement

cost: National

authorities have

to check

applications

and judge them.

Key area 9: Animal

health requirements

for entry conditions

for into the Union of

animals, germinal

products and