1. Procedural issues and consultation of interested parties.. 4

1.1. Consultation of Member States' Experts. 5

1.2. Animal Health Advisory Committee. 5

1.3. Animal Health Law Stakeholder Steering Group. 6

1.4. Inter-Service Steering Group (ISSG) 6

1.5. General on-line consultation. 6

1.6. Consultation of competent authorities of MS and the industry on administrative burdens. 7

1.7. Other opportunities used for consultation. 7

1.8. IAB opinion. 7

2. Policy context, problems identified, and subsidiarity.. 11

2.1. Background and context 11

2.1.1. Nature and size of the sectors concerned. 11

2.1.2. Overview of legislative framework and ongoing developments. 13

2.2. Problem definition. 14

2.2.1. High Complexity of the current CAHP. 15

2.2.2. Lack of a single overall strategy. 21

2.2.3. Insufficient focus on disease prevention. 24

2.2.4. Rules for intra-EU trade of live terrestrial animals are sub-optimal 27

2.3. Who is affected by the current policy?. 30

2.4. The right and justification for EU action. 30

2.4.1. Treaty basis. 30

2.4.2. Subsidiarity test 30

3. Objectives.. 34

3.1. General objectives. 34

3.2. Specific objectives. 35

3.3. Operational objectives: 35

4. Options.. 36

4.1. Option 1 - Do nothing. 36

4.2. Option 2 – Simplification of existing legislation with no major content or policy changes. 36

4.3. Option 3 – Existing legal framework with more self-regulation. 36

4.4. Option 4 - Flexible general legislative framework on animal health issues (AHL) 37

4.5. Option 5 - Prescriptive general legislative framework on animal health issues (AHL) 37

4.6. Key elements of the different options. 37

5. Impact analysis.. 41

5.1. Option 1 – No Change. 41

5.2. Option 2 – Simplification of existing legal framework with no significant policy change. 43

5.3. Option 3 – Existing legal framework with more self-regulation. 43

5.3.1. Economic impacts. 45

5.3.2. Social Impacts. 46

5.3.3. Environmental impacts. 46

5.4. Option 4 – flexible general legislative framework for animal health issues. 46

5.4.1. Economic impacts. 47

5.4.2. Social Impacts. 50

5.4.3. Environmental impacts. 50

5.5. Option 5 – prescriptive general legislative framework for animal health issues. 51

5.5.1. Economic impacts. 51

5.5.2. Social impacts. 53

5.5.3. Environmental impacts. 53

6. How do the options compare?.. 54

7. How will the option implemented be assessed?.. 56

ANNEX I Glossary of technical terms and abbreviations.. 58

ANNEX II Key Messages from the evaluation of the Community Animal Health Policy (CAHP) 60

ANNEX III Summary of chronology of main exchanges with representatives of specific sectors likely to be affected by the new AH Law... 62

ANNEX IV Summary document of the stakeholders' steering group: "Problem identification during the creation of the animal health law". 64

ANNEX V Summary of Consultation Responses.. 73

ANNEX VI Summary of the questionnaire on artificial insemination and related issues 110

ANNEX VII Vaccination policy.. 122

ANNEX VIII Additional assessment on Intra-EU trade.. 151

ANNEX IX Key elements of the new Animal Health Law, including indicative list of existing legislation affected.. 162

ANNEX X Preliminary structure of the legislative proposal – options 4 and 5 172

ANNEX XI Additional assessment on biosecurity.. 173

1. Procedural issues and consultation of interested parties

The proposal for action on the EU animal health policy is the result of a long series of considered analyses.

In 2004, the Commission launched an independent evaluation to assess the performance of the Community Animal Health Policy (CAHP)[1] over the previous decade and its coherence with other EU policy interventions. The aim was to identify elements of the CAHP which could be further improved and to propose options to achieve these improvements. The summary of the key messages of the CAHP evaluation is attached at Annex II, and also discussed in further detail below.

Among other things, the CAHP evaluation recommended that a single strategy for animal health be developed to prevent piecemeal and crisis-driven development of policy. The EU Animal Health Strategy 2007-2013 (AHS) "Prevention is better than cure" was the result[2].

The AHS provides for the adoption of a "single regulatory framework for animal health with a greater focus on incentives than penalties, consistent with other EU policies and converging to international standards" and which will "define and integrate common principles and requirements of existing legislation". In their reaction to the Commission Communication on the new Strategy, the European Parliament[3], the Council[4] and the European Economic and Social Committee[5] welcomed this initiative. Subsequently, the Action Plan for the implementation of the Strategy[6] confirmed that "the main objective of the Strategy is the development of an EU Animal Health Law (AHL)".

From the very start of the process, key stakeholders, Member States (MS) Competent Authorities (CA), international organisations and trading partners have been closely involved and have played a crucial role in the discussion. In addition, economic and social stakeholders such as European associations with an interest in animal health and welfare and the interested public have been consulted on a number of occasions in accordance with the Commission’s standards for consultation.

This exercise represents a considerable contribution to the so-called "fitness check" of the food safety and health policy and legislation.

At the same time, it reflects the priorities of Smart Regulation[7] by aiming to simplify the existing legal framework while reflecting stakeholders' expectations in reducing administrative burdens.

And finally, it reflects Commission priorities such as the smart growth objective of the Europe 2020 strategy[8] by helping the sector to become more resilient due to active prevention measures and risk management.

This Impact Assessment (IA) follows the structure given in the Commission’s IA guidelines[9]. It aims to consider the economic, social and environmental aspects of EU policy on animal health in an integrated and proportionate way.

1.1. Consultation of Member States' Experts

CA of the MS have been involved in the preparation of this initiative from an early stage.

Preparatory work started in the frame of the expert working group meetings of the Chief Veterinary Officers of the MS (CVOs). Several working groups were created (in the so-called Adelbrecht process) in order to obtain guidance from the CVOs on the implementation of the new AHS. Commission officials also participated in the working groups. The conclusions of the various working groups on issues such as prioritization of EU intervention and categorization of animal diseases, biosecurity and the use of the veterinary fund are publicly available.[10]

As a continuation of this work, several seminars were organised by the EU presidencies to discuss major issues related to the AHL proposal. These led to the adoption of the set of CVO Conclusions on biosecurity and incentives for prevention (October 2009)[11] and on animal disease surveillance systems (April 2010)[12].

Furthermore, as explained in greater detail under point 1.3, representatives of several MS formed part of the AHL Steering Group.

MS have been updated regularly by the Commission on the development of the AHL during both the Council and Commission CVO meetings and the Standing Committee of the Food Chain and Animal Health (SCOFCAH).

1.2. Animal Health Advisory Committee

The Animal Health Advisory Committee was created as a working group of the Advisory Group on the Food Chain and Animal and Plant Health[13]. It is chaired by a Commission representative, with the special participation of three representatives of CVOs from three MS (the past, present and future Presidencies). The list of other key stakeholders is publicly available[14] as are the agendas, the presentations, the summaries and the participants for each meeting[15].

A consultation and regular update on the progress of the work was provided at numerous meetings of this Committee[16] in order to ascertain stakeholders’ perceptions of the issues identified, to collect views about the possible options to solve them and to sound out stakeholders on the likely acceptability of the various options.

Ad hoc bilateral meetings were held with the representatives of the specific sectors likely to be affected, including key associations (see summary of chronology of main exchanges in Annex III).

1.3. Animal Health Law Stakeholder Steering Group

An AHL Stakeholder Steering Group was set up to assist the Commission Services during the impact assessment process. Its assistance was particularly important in the definition of problems.

This group comprised experts from national veterinary authorities, experts from international organizations and other interested stakeholders.

In particular, delegates from the national veterinary authorities of Germany, Italy, Hungary, Denmark, the United Kingdom, Belgium, Sweden, Slovenia, Lithuania, Finland, the Netherlands, France and Switzerland participated, as well as delegates from the following international, economic or non-governmental organisations: COPA-COGECA (European farmers and European agri-cooperatives), OIE (World Organization for Animal Health), UECBV (European Livestock and Meat Trading Union), FVE (Federation of Veterinarians of Europe), FESASS (European Federation for Animal Health and Sanitary Security), IFAH-Europe (International Federation for Animal Health Europe), FEAP (Federation of European Aquaculture Producers), AVEC (Association of Poultry Processors and Poultry Trade in the EU countries), Vier Pfoten (Four Paws international).

The steering group had 4 meetings during the first part of 2009, and working papers were used during the meetings to focus on and consider particular factors.[17] The work of the steering group is summarised in a document entitled "Problem identification during the creation of the AHL" which can be found in Annex IV.

1.4. Inter-Service Steering Group (ISSG)

Given the crosscutting nature of the issues concerned, the Commission set up an ISSG to provide specialised input and to bring a wider perspective to the process.

Five meetings of the ISSG were held (31 October 2008, 10 February 2009, 9 July 2009, 5 July 2010, 14 April 2011) in order to obtain other services’ views about the issues identified, the possible options and likely impacts in addition to a formal 'Consultation Inter-Service' (CIS) on the AHL consultation document in August / September 2009.

The following services were invited: SG, SJ, AGRI, COMP, ENTR, ENV, RTD, MARKT, MARE, OLAF, TRADE, RELEX, ELARG. As far as possible, the comments expressed by the various DGs represented at the five meetings have been taken into account in this document.

1.5. General on-line consultation

A general consultation addressed to the general public, stakeholders, MS and third countries was carried out from 23 October to 31 December 2009 via an online Interactive Policy Making tool.[18] The outcome of this consultation was used as part of the analysis of impacts. The statistics and a summary of the main findings are available at Annex V.

1.6. Consultation of competent authorities of MS and the industry on administrative burdens

Two questionnaires were developed in order to collect readily available data on administrative burdens and administrative costs for the competent authorities and the operators.[19] Data on compliance costs incurred by operators when implementing current EU animal health legislation and data concerning the expected potential impact of the proposal on administrative burdens for enterprises and competent authorities were also requested in the questionnaires.

Where relevant, the results of this consultation have been used to analyse the impacts of the different proposed options and to identify opportunities for cost reduction.

1.7. Other opportunities used for consultation

EU producers of semen, ova and embryos were the target of a separate questionnaire for gathering data to compare possible options for animal health rules for intra-EU trade. The submitted data was used to assess the impacts of the different options identified. An ad-hoc meeting between the Commission services and the RepVet group of COPA-COGECA was organised to explain the different possible options in order to facilitate answering the questionnaire. The results of that questionnaire can be found in Annex VI.

A task force of experts assisted the Commission in the development of an expert paper[20] on EU vaccine/antigen banks for major animal diseases (such as foot and mouth disease, classical swine fever etc.). Based on that work a questionnaire on emergency vaccination policy prepared by Commission services was addressed to the EU CVOs. The analysis of the replies can be found in Annex VII (part 2).[21]

In addition to the discussions at CVO level, special emphasis was given to the concept of surveillance and its introduction in the new AHL during the Task Force for Animal Disease Surveillance (TFADS). This Task Force was created in November 2008 to support the MS and the Commission services. Two meetings of this expert group, which took place on 16-17 December 2009 and 17-18 May 2010, reflected on the ways in which surveillance should be introduced in the new AHL. This provided expertise and experience on animal disease surveillance in the context of animal disease management, and summaries of the meetings can be found here: http://ec.europa.eu/food/animal/diseases/surveillance/index_en.htm. In addition, the Spanish Presidency held a seminar on animal disease surveillance as part of the Working Party of Chief Veterinary Officers.

1.8. IAB opinion

The draft IA report was discussed at the meeting of the IAB on 13 July 2011. Following this meeting the board issued an opinion on the draft IA emphasising four main points to be addressed in the final version of the IA report.

These four main points have been addressed in this revised version of the IA as follows:

(1) Strengthen the evidence regarding the seriousness of problems:

- The background of evaluation of existing law and development of strategy is now more clearly explained in the first paragraph to the IA.

- More extensive explanations are now given on the problems generated by the lack of a single and fully coherent EU legal framework.

- A summary of the key findings of the CAHP evaluation has now been annexed to the IA (new Annex II) to better explain the background to the development of the AH strategy, the thinking behind the AHL and the stakeholders views collected in this exercise.

- The summary of the main findings of the stakeholder consultation is now annexed to the IA rather than a reference made to a web-link (new Annex V).

- The results from the stakeholder consultation have now also been referred to in each relevant problem identified; including showing how many would support a change in the existing legislation. Examples have also been added of particular problems highlighted by the AHL steering group.

- In Point 2.2.1., a paragraph has now been added to explain who is affected by regulatory over-complexity and how.

(2) Clarify what each option involves and add a simplification only option:

- A new 'simplification only' option 2 has been added in sections 4 and 5 and explanations are given for why this is not a viable option.

- A new point 4.6 has been introduced to explain more clearly the new elements that would be introduced by each option.

- Changes have been made to the legislation table (now Annex IX), to outline more precisely the changes planned in the new legislation. In this new Annex IX an introductory chapter has also been added to explain the key new elements of the future AHL, in accordance with options 4 and 5. Some details are also provided to outline the elements of the existing legislation and map them onto the new AHL and/or the delegated and implementing acts that should follow it, although full details cannot be provided at this stage.

- A new Annex X has been introduced showing the structure of the new AHL in accordance with options 4 and 5.

(3) Present adequate information regarding vaccination issues:

- The current EU approach to vaccination has been explained and assessed in new Part 1 of Annex VII.

- The conclusions of this assessment are presented in the main text of the IA.

(4) Properly assess administrative burden arising from familiarisation activities:

- In point 5.4.1. and 5.5.1., a short explanation has been provided why familiarisation costs for the new AH framework law have not been quantified by the Standard Cost Model (SCM) but rather identified as being part of the business-as-usual costs for business and competent authorities alike, given the individual and different natures of animal diseases and subsequent frequent adaptations of the legal framework.

The IA executive summary has been changed accordingly to reflect the changes of the main report. In addition, this version of the IA includes several improvements to better respond to the IA Quality Checklist for IAB Opinion.

The Impact Assessment was re-submitted to the IAB in September 2011 with these amendments made. Some further changes were requested by the IAB and have been addressed as follows:

(1) Clarify what the preferred option involves in terms of non-commercial actors, biosecurity and future Impact Assessments.

- More analysis has been made in section 5.4.1 of the impact of option 4 on non-commercial actors, particularly in economic impacts.

- Option labels in the Annex XI on biosecurity have been changed for clarity, and the options linked back specifically to options in the main text.

- A set of sub-options in table 4.1 has been removed where its impacts have not been separately analysed.

- A paragraph has been added at the start of Annex IX to give examples of where further impact assessments might be required.

(2) Present further evidence regarding the seriousness of particular problems.

- An FVE report has been cited as evidence around the lack of consistency in training for veterinarians in section 2.2.1.5.

- Some more explanation of the problems faced in regulatory over-complexity has been made in section 2.2.1.6, using Food and Veterinary Office (FVO) reports as evidence.

(3) Consistently describe vaccination options

- The main text of the report has been linked more explicitly to Annex VII on vaccination, particularly in table 4.1 in section 1.

- The option labels in Annex VII have been changed to provide more clarity and for ease of linkage with the main text.

- Annex VII has more analysis of stakeholder views and the need for subsidiarity.

(4) Better explain administrative burden analysis

- The impacts of new information obligations have been covered more explicitly in section 5.4.1 in examining the analysis of economic impacts of the preferred option 4.

(D) Procedure and presentation

- A sentence has been added at the end of section 7 to cover the proposed evaluation timetable.

2. Policy context, problems identified, and subsidiarity 2.1. Background and context 2.1.1. Nature and size of the sectors concerned

Across the EU, the farming sector is the largest user of animals with at least 2 billion birds (chickens, laying hens, turkeys, etc.) and 334 million mammals (pigs, sheep, goats, cattle, fur animals, etc.). There are 13.7 million animal holdings in the EU.[22]

The value of livestock farming output in the EU is €149 billion[23] of which pigs and poultry (subject to specific EU provisions) represent 38% (i.e. €57.6 billion). Animal output value represents 41% of the overall agricultural output (€363 billion in 2008).

According to Eurostat, total aquaculture production in the European Union (EU-27) in 2005 was 1,272,455 tonnes (live weight). This includes production of crustaceans, molluscs, and finfish[24]. The total value of production is estimated as €3,159bn.

Pet animals represent the second largest type or usage of animals, by number, in the EU. There are around 120 million dogs and cats, and approximately 35 million pet birds. The annual value of cat and dog sales in the EU is estimated at €1.3 billion and the sector is estimated to generate direct employment of 300,000 persons, including 32,000 dog breeders.

Many fewer animals are used for experimentation (pharmaceutical and cosmetic industries and public research bodies): around 12 million animals in the EU, of which most are rodents. There are between 2,000 and 3,000 zoos in the EU and there are an estimated 800,000 captive wild animals. The fur farming sector also farms a significant number of animals, covering about 7,200 farmers and producing around 32 million pelts per year[25]. No reliable data could be obtained for circuses or other activities such as animals used in sports, shows, etc.

EU intervention is currently focused primarily on the prevention and control of major transmissible diseases that can have significant health and economic impacts at EU level. Animal diseases do not recognize borders and present a constant threat to all of the sectors above. They pose a direct risk to animal and often public health, but also can have other negative but indirect impacts, such as economic or social effects. The unpredictable occurrence and behaviour of animal disease epidemics and the still insufficient reliability of modelling studies, despite the recent progress made in this field, makes forecasting their frequency and impact very difficult.

The impacts of an animal disease outbreak can vary widely due to a variety of factors including the epidemiological characteristics of the disease, the structure of the sectors affected and the nature of the control measures imposed. These impacts can include negative effects for animal and human health, costs to livestock farmers and related industries of dealing with disease and of business disruption, public sector costs of eradication and monitoring, and changes in consumption patterns. Often, disease outbreaks also have significant impacts on international trade of animals and animal products. Finally, many animal diseases also affect wild animals, and may have detrimental effects on wild animal populations. Thus they can have a negative environmental impact, for example, on biodiversity.

Some of the consequence of past animal health crises have been used to illustrate the potential scale of the impacts of animal disease outbreaks.

§ BSE (1996-1997): for UK only, GBP£3.5 billion (0.5% of GDP). The disease also caused a serious fall in consumer confidence across the whole EU and the deaths of more than 200 people in the last 15 years.

§ FMD (2001-2002): for UK only, GBP£10-12 billion (1.2% of GDP) mainly in agriculture / food chain (30%) and tourism (50%).

§ SARS (2003): (cost of lost GDP: US$18bn in East and Southeast Asia (0.6% of GDP) (Asian Development Bank); estimated global economic impact US$30bn (World Health Organisation, 2003). Around 800 people ultimately died from the illness.

§ Avian flu in the Netherlands (2003): 30 million birds and direct economic costs of more than €150 million. A veterinarian died due to this disease.

The EU emergency fund[26] makes financial contributions to MS during animal disease outbreaks[27]. It would usually make a contribution of 50% (with the remaining 50% covered by the MS) of the direct costs to animal keepers for certain specified diseases. Table 1.1 below sets out contributions since 2000. As shown, the total amount paid since 2000 is just over €1 billion. However, it should be noted that of this, €664 million (63% of total) was paid between 2002-2005 in relation to Foot and Mouth outbreaks in 2001.

Table 1.1: EU Emergency Fund Payments by Disease from 2000-2010

Year of Payment || Payments in €m

Avian Influenza || Bluetongue - disease, surveillance & vaccination || Classical swine fever || FMD || Newcastle disease || Other Diseases || Grand Total

2000 || 13.79 || || 47.05 || || || || 60.84

2001 || 17.00 || 0.73 || 6.28 || || || || 24.01

2002 || || 11.46 || 11.42 || 400.44 || 0.42 || 0.57 || 424.32

2003 || 4.76 || 0.47 || 1.78 || 67.82 || || || 74.84

2004 || 55.92 || 4.14 || 8.92 || 78.73 || 1.00 || || 148.71

2005 || 18.23 || 2.65 || 4.16 || 119.96 || 0.65 || || 145.64

2006 || 0.05 || 0.10 || 1.63 || || || || 1.78

2007 || 1.00 || 4.27 || 5.00 || || 0.22 || 1.20 || 11.69

2008 || 8.65 || 51.00 || 3.32 || 0.46 || 0.14 || || 63.56

2009 || 3.90 || 36.36 || 0.04 || || 0.36 || || 40.66

2010 || 1.27 || 31.75 || 0.02 || 0.72 || || 17.18 || 50.94

Grand Total || 124.57 || 142.93 || 89.63 || 668.14 || 2.79 || 18.95 || 1,046.99

Animals must fulfil specific animal health conditions when they are moved between MS or imported from third countries. Indeed there are areas within the EU with different health statuses (for example, freedom from certain animal diseases). These conditions ensure that animals do not pose any risk during movement and they are moved only to an area of equal or lower health status than their place of origin. The conditions are attested by official veterinary certificates accompanying the consignment of the animals from their origin to their destination.

These specific rules for movements are sometimes considered burdensome, especially in the case of frequent cross-border movements between two adjacent MSs with a similar or identical health status. The most often cited examples of movements of this kind are those of pigs and poultry between Germany and the Netherlands; cattle between France, Belgium and Luxembourg; animals for slaughter between Austria and Germany; and cattle, pigs and sheep between Ireland and Northern Ireland (in the UK). More detailed analysis (along with some assessment of policy options referred to in Section 4 later) is available in Annex VIII.

2.1.2. Overview of legislative framework and ongoing developments

The current EU animal health legislative framework involves almost 50 basic directives and regulations, some of them adopted as early as 1964. The veterinary acquis communautaire now covers more than 400 acts:

- c. 50 basic acts that lay down horizontal and vertical principles of animal health which apply to intra-Community trade, imports, disease eradication, veterinary controls, notification of diseases and financial support of terrestrial and aquatic animal. A provisional list of legislation expected to be affected by the new legal framework is attached in Annex IX;

- c. 200 acts of general application that lay down implementing rules such as the ones that specify lists of third countries, or the rules on veterinary certification;

- c. 200 acts of special application that lay down more specific provisions such as rules on protection or transitional measures.

This set of animal health legislation interacts with the current legal framework on animal welfare, food safety, public health, animal nutrition, veterinary medicinal products, environmental protection, official controls, the Common Fisheries Policy (CFP) and the Common Agricultural Policy (CAP). A new proposal would need to successfully interlink with all these sets of legislation, especially with Regulation (EC) No. 882/2004[28], so as to increase consistency for official controls (checks) related to animal health.

For the aquatic sector, Directive 2006/88/EC was adopted in 2006, bringing together disease control and trade provisions (intra-EU movements and import). This amalgamation was a new concept, which has proven to work fairly successfully, so no policy changes are being proposed in this area. Therefore, this Impact Assessment largely focuses on policies relating to terrestrial animals.

2.2. Problem definition

As noted in Section 1 above, problems with the existing animal health framework and suggestions for improvements to it have been identified in a number of fora. Subsequent to the evaluation of the CAHP and the development of the EU AHS 2007-2013, stakeholders and competent authorities of the MS were then further asked to identify problems with current legislation on animal health in the scope of the AHL Steering Group. The replies served as a basis to develop the "Annotated agenda for a wide stakeholder consultation" in which stakeholders were asked to raise any issues of concern as regards current legislation on animal health. The summary of this consultation is available at Annex V.

The CAHP Evaluation and the stakeholders' consultation broadly agreed that the current system functioned well, however a number of issues were identified that could be improved. Some relate to the general policy approach whilst others relate to specific legal acts or diseases. Some of these issues should be addressed by stakeholders as part of their responsibility to prevent animal diseases, but others relate to the responsibilities of the EU and of CA.

As the AHS recommends that the AHL should be a general horizontal legislative framework, this impact assessment focuses on the main problems identified in the general policy approach. Some of the more specific problems identified during the wide stakeholders' consultation have been used in this impact assessment as examples of the general problems. Others will be addressed, if needed, in subsequent legislative proposals and impact assessments – see Annex IX for more details.

As noted above, a summary of the key messages from the CAHP is available at Annex II; however the main thematic issues identified during the CAHP evaluation were:

- The high complexity of the current CAHP

- The lack of an overall strategy

- An insufficient focus on disease prevention, with a particular focus on the need for increased biosecurity.

A specific policy issue was also identified both in the evaluation and in the consultation with stakeholders in the framework of the AHL preparatory work:

- Issues related to intra-EU trade in live animals.

These trade issues cut across the general problems identified in the first three bullets. As such, further more specific analysis was carried out on intra-EU trade, which is presented in overview in section 5 and in detail in Annex VIII.

2.2.1. High Complexity of the current CAHP

As described above, current EU animal health legislation is very complex, with over 400 pieces of legislation, but no single horizontal law containing the overarching principles, main objectives and tools of animal health policy. This means that legal measures are spread among very many different pieces of legislation with different subject matters, including a mixture of horizontal and vertical issues, trade (intra-EU and international), disease control measures and specific safeguard measures.

Within the current framework there are not always clear links to other relevant legislation, and there can be a lack of consistency and transparency across the various existing animal health legislation. The existing veterinary legislation and policies were widely perceived to be very complex by stakeholders across the board during the evaluation of the CAHP.

The high complexity of the current system means it can be difficult for stakeholders (whether CA, veterinary professionals or farmers and operators 'on the ground') to understand their roles and responsibilities. Since this complexity and lack of clarity are caused by the shortcomings of the existing legal framework, they cannot be adequately mitigated by means of training or other familiarisation exercises only. Consequently, the current complexity has the potential to jeopardise the achievement of the EU's animal health objectives.

All the specific problems identified below within the overall problem of 'high complexity of the current CAHP' relate to the implementation of the current legislation, with the exception of the lack of rules on professional qualifications and training for official veterinarians (see 2.2.1.5), which relates to a lack of legislation.

2.2.1.1. Large number of pieces of EU animal health legislation

Driver: Large number of pieces of EU animal health legislation but no single horizontal law.

Problem: Potential high administrative burden for stakeholders to understand legislation.

The absence of a single horizontal act containing the overarching principles means that obligations are scattered in different legal acts. This can mean that the rules can be unclear or difficult to comprehend for animal keepers and owners. They may need to consult many different pieces of legislation or consult a specialist before they can fulfil their obligations. Some obligations are laid down in legislation dealing with disease outbreaks which could be outside their day-to-day areas of activity. There can also be a lack of clarity about the relationship between animal health legislation and other pillars of legislation. So it can potentially be difficult for stakeholders to fully comprehend their roles and responsibilities in the current animal health framework. Nevertheless, this situation can vary between MS according to the manner in which they have transposed directives, with some potentially offering more coherence than others.

Nevertheless, it is clear that the time spent by animal keepers and operators familiarising themselves with their statutory obligations represents an administrative burden. This could be through the time spent by operators reading legislation (or more likely guidance about the legislation), or the cost of consulting legal experts. When aggregated across the several million animal keepers, operators and related business operators in the EU, this is clearly a considerable administrative burden.

2.2.1.2. Responsibilities and obligations of animal keepers and owners are not always clearly spelled out

Driver: Existing roles and responsibilities differ across existing legislation and in many cases are not clearly laid down and consequently interpreted differently in different MS.

Problems: Animal keepers' legal responsibilities as they are expressed in the current legal framework do not reflect the totality of the role of keepers and operators in animal disease prevention and management. Differences in responsibilities between MS may lead to varying costs of complying with obligations between keepers in different MS.

Animal keepers and owners, especially farmers, are well placed to prevent and detect animal diseases, but they can also contribute to the frequency and scale of disease outbreaks. Current EU and/or national legislation already sets certain obligations for animal keepers and owners, such as:

- notifying the keeping or possession of animals,

- notifying the relevant authority of the presence or suspected presence of certain diseases without delay,

- providing regular care for and supervision of the animals,

- handling animals with a certain standard of care,

- reporting the dispatch and/or arrival of animal consignments,

- keeping records and registers and providing for the identification and traceability of animals,

- having a baseline knowledge of animal diseases and how to prevent them.

Most of these obligations are laid down in Directives and Decisions which are then transposed by MS, but some others are not regulated at EU level. For example, there are currently very few mechanisms at EU level which actively involve animal keepers in the rapid notification of suspected animal disease or on-farm preventive measures, but many of these types of mechanism exist at national or regional levels.

The current framework creates a particular problem. Because many of the obligations are in Directives, they can be transposed into MS legislation differently. MS sometimes interpret the obligations in different ways so there are disparities in obligations related to animal health for animal keepers and owners between MS. These inconsistencies between MS mean that the responsibilities of animal keepers vary across the EU, which can alter the costs of complying with legislation. This in turn leads to an uneven playing field for livestock keepers in different MS in relation to the cost and responsibilities of national animal health requirements.

During the stakeholder consultation, there was wide support for clarifying these responsibilities, with 78.4% of respondents replying 'agree' or 'strongly agree' to the proposal to clearly setting out obligations of animal keepers/owners/operators. In particular many of the stakeholders stressed the need to establish obligations for operators as well as for animal keepers. The impacts on small farmers have to be taken into consideration. Furthermore, the third countries replying to the questionnaire stressed that these obligations should not be imposed on third country operators.

2.2.1.3 Rules for commercial farming do not always apply in a proportionate manner to non-commercial animal keeping

Driver: To establish better consistency and proportionality to address risk posed by non-commercial animal keeping.

Problem: Non-commercial animal keeping usually entails a different kind and level of disease risk compared to industrial farming and the administrative burdens imposed on non-commercial animal keeping is not always proportionate to the level of disease risk.

During the consultations, concerns were raised that surveillance and disease control measures are applied identically to both commercial and non-commercial holdings (such as hobby and backyard holdings). The necessity of the current application of measures to non-commercial farming (such as for example the obligation to identify and register certain animals and the holding registration), was questioned, given the different levels of risk that they pose.

To ensure appropriate animal health in the EU and for effective prevention and control of animal disease, at least a basic level of control measures need to be applied to both categories of holdings as they can both be affected by disease and become a source of wider infection. In some circumstances, non-commercial holdings can pose a lower risk of spreading diseases compared to industrial holdings: for example, because of fewer movements, less contact with other animals (especially with industrially farmed animals), animals being kept in smaller groups and more contact between the keepers and the animals (see studies on the spread of Avian Influenza). On the other hand there are circumstances where high numbers of small non-commercial holdings can present a potentially major risk of spreading diseases to industrial farming. An example of this might be small-scale pig production. The risk of disease can arise from potentially lower biosecurity levels in such holdings such as increased wildlife contact, less supervised movement control, swill feeding, uncontrolled disposal of carcasses, etc.

Current practices also raise some questions about intra-EU movements, specifically whether different conditions should be applied to commercial and non-commercial movements. Some species of animals are considered not to represent a high risk for spreading animal diseases, or are kept or bred in certain particular and well controlled biologically secure conditions (for example, laboratories, zoos, circuses etc.). Pet animals are often moved in a different context, that is to say, they move in accompanying their owners on their journeys. So they have little contact with farmed (or in fact any other) animals and the risk of spreading disease is much lower. However, the movements do need to be somewhat traceable and controllable in case of disease outbreaks posing risks to animal or human health.

The stakeholder consultation showed a high level of support for the Commission's approach for differentiated rules for commercial and non-commercial movements, providing possibilities for risk based exemptions on a case-by case basis (74.5% of respondents agreed or strongly agreed with the suggested approach). However, a certain extent of uneasiness was observed as a significant percentage of respondents argued that changes could lead to an increased risk of animal disease spread and possible outbreaks. (for full details see 2.8 in Annex V).

2.2.1.4. Unclear definition of the role of veterinary services including the tasks and duties of official veterinarians, and other veterinary practitioners.

Driver: Inconsistency in the role of veterinary services across existing EU legislation.

Problems: Legal uncertainty about roles of veterinary services, possible conflicts of interest and limits to the development of veterinary networks.

EU legislation (such as Council Directive 90/425/EEC, Regulation (EC) No 882/2004, Council Directive 64/432/EEC, and Regulation (EC) 854/2004) gives different definitions of ‘competent authority’, ‘official veterinarian’, ‘approved veterinarian’ and 'official auxiliary'. This lack of legal clarity has paved the way for different interpretations by the MS, and an uncertainty about the roles of the various segments of veterinary services during animal disease outbreaks.

For example, the majority of MSs' veterinary practitioners or technicians are authorised to perform a range of official veterinary activities, including sampling (for example, in the cases of brucellosis, tuberculosis, Aujeszky’s disease and the tuberculosis skin test), vaccination (for example, for Bluetongue) and also some clear-cut official controls, such as regular hygiene checks on dairy farms, or health checks of animals prior to intra-EU trade dispatch. In other MS, official tasks such as these are only performed by official veterinarians.

The steering group consultation also raised concerns that a veterinary practitioner might face a ‘conflict of interest’ when certifying animals in his or her care; for example if carrying out work as an official veterinarian but also undertaking private veterinary work, perhaps for the same client.

Different roles for veterinary services across the EU could limit veterinary coordination and the development of networks for the surveillance, prevention, early detection, control and notification of disease.

At the same time, all MS are members of the World Organisation for Animal Health (OIE). The OIE Terrestrial and Aquatic Animal Health Codes provide existing frameworks to which EU rules should be aligned in order to ensure that MS are fulfilling their obligations as OIE members, which, amongst other positive benefits, facilitates trade with third countries. The Terrestrial Animal Health Code defines the concept of ‘Veterinary Services’ as the governmental and non-governmental organisations that implement animal health and welfare measures and other standards and recommendations in the two OIE codes in the territory. The Veterinary Services are under the overall control and direction of the Veterinary Authority. Private sector veterinary organisations, veterinarians, veterinary paraprofessionals or aquatic animal health professionals are therefore included in Veterinary Services and they are normally accredited or approved by the Veterinary Authority to deliver the delegated functions. The tasks of veterinary services include many programming and management activities, including international certification, and particularly the organisation of a veterinary network for the prevention, control and notification of disease outbreaks. International trade in animals, animal products and products of animal origin is based on international (OIE) standards, where the first step in fulfilling import conditions is a successful evaluation of the veterinary services in a given potential exporting country. Without that evaluation, health certification is not reliable and export is therefore not possible under OIE rules.

However, it has to be noted that in aquaculture, apiculture and some other animal categories (such as animals used in scientific experiments) control activities may be carried out not only by veterinarians but by other professions and services. In this regard, international standards and recommendations set in the OIE Terrestrial and Aquatic Codes have to be taken into account.

This variety in the structure of differing veterinary services, their relationships nationally, intra-EU and internationally, and the differences in their roles and responsibilities, adds to the complexity of the current context. During the stakeholder consultation, 81.7% of respondents agreed with the suggestion to clarify the tasks and duties of official veterinarians and veterinary practitioners (for full details see 2.3 in Annex V). Stakeholders are of the view that there is a need to clarify and harmonise certain veterinary tasks EU-wide. This is in particular valid for "export certification" and international trade.

2.2.1.5. Lack of rules on the professional qualifications and training for official and approved veterinarians

Driver: Diverging national standards for qualification and training for official and approved veterinarians.

Problem: Differences between levels of health protection across MS due to the differences in veterinary qualifications, ongoing training and professional development.

Official, approved and authorised veterinarians need in-depth and regularly updated knowledge and skills to perform official tasks and official controls adequately. This knowledge will be gained first through undergraduate veterinary education and then by postgraduate studies and/or vocational training. Differences in these qualifications between MS mean that there can be differing levels of health protection and impartiality throughout the EU.

The Federation of Veterinarians of Europe (FVE) and the European Association of Establishments for Veterinary Education (EAEVE) run an evaluation system of veterinary schools in MSs with a view to providing an independent and fair accreditation system. The latest published evaluation, in 2009, concluded that while many veterinary schools in the EU are world-class, some 16% are at one or more points inadequate[29]. This variability in education can lead to inconsistency in the knowledge of those who qualify as vets.

Regulation (EC) No 882/2004 already envisages appropriate and, as necessary, additional training for staff performing official control tasks. In addition, there are specific provisions on the professional qualifications and continuing education of official veterinarians, but this is limited to those responsible for fresh meat controls in establishments covered by Regulation (EC) No 854/2004. These provisions may need to be extended to other areas of competence of official veterinarians to ensure that official tasks are performed in an adequate and uniform way throughout the EU. At the same time it has to be noted that in aquaculture, apiculture and some other animal categories (i.e. experimental animals), control activities may be carried out not only by veterinarians but by other professions and services. This would have to be taken into account as necessary in defining the required qualifications and ongoing professional development.

During the stakeholder consultation, there was wide support for extending the requirements for professional qualification and for veterinary training for officials veterinarians in all areas, and to those authorised to perform official tasks in the field of animal health, with 81.0% of respondents replying 'agree' or 'strongly agree'. Many supported a broader harmonised EU approach for all those that perform official tasks; this includes not only veterinarians but also other professionals. On the other hand, others warn that MS already have continuous professional developments for veterinarians in place and that additional regulation at EU level is unnecessary. If training is to be introduced, it should be output / target oriented towards proper enforcement and should not generate unnecessary costs. (for full details see 2.4 in Annex V).

2.2.1.6. Specific animal health conditions relating to imports are difficult to understand, and apply

Driver: Animal health conditions on imports are unclear and difficult to apply.

Problem: Administrative burden for third countries, importers and competent authorities to understand and comply with conditions.

Animal health import requirements for live animals, animal products and products of animal origin are based on the need to prevent the introduction of animal diseases into the EU. These specific requirements are scattered in different pieces of legislation and sometimes within the texts of import certificates instead of the legal act itself.

This makes the rules difficult to understand and apply for competent authorities and business operators in MS and third countries. For example, the Food and Veterinary Office (FVO) has regularly made recommendations to MS to improve their import controls. Many of the issues causing the recommendations appear to arise from misunderstandings due to a lack of clarity rather than wilful disregard. In addition, the complexity adds an administrative burden to operators, who can find it difficult to establish what the requirements for import actually are. The introduction of basic animal health requirements would reduce the administrative familiarisation burden on operators who are running import businesses, and grant more consistency in import policy.

The time spent by the concerned parties understanding animal health import conditions represents an administrative burden for business operators and competent authorities in both MS and third countries which has the potential to be reduced through simplification, harmonisation of the controls, and the introduction of electronic forms.

During the stakeholder consultation, 75.1% of respondents replied 'agree' or 'strongly agree' to the proposals to make the import conditions clearer and simpler. For full details of the proposals see 2.12 and 2.9 in Annex V. Stakeholders especially highlighted the issue of competitiveness: they are of the view that EU operators face stricter standards than international standards. Imports of special animal categories also have to be considered carefully, and exemptions only granted taking into consideration the risks involved (e.g. protected and endangered species, wild animals, etc). They emphasised the need for clear definitions to avoid misunderstanding in import conditions (for example, llamas should not be considered as ruminants).

2.2.2. Lack of a single overall strategy

The final report of the CAHP evaluation highlighted the lack of a single general approach behind the CAHP measures. Instead, the CAHP was perceived to be a patchwork of specific measures and actions, with insufficient clarity in its overall direction. The setting of priorities for the CAHP has consisted of a mixture of longer-term components such as eradication programmes or contingency planning but also of short-term or crisis-driven elements.

Resources, personnel and management attention have tended to follow animal health crises with a reducing focus on the definition and achievement of longer-term strategic objectives. Consequently, this apparent lack of a clear long-term strategy and prioritisation system could lead to sub-optimal prioritisation and allocation of resources.

All of the problems identified below which relate to the lack of a single overall strategy are areas where EU law exists only in piecemeal fashion (for example, relating only to certain diseases); or where there is no existing law.

2.2.2.1. Lack of categorisation and prioritisation of animal disease policy

Driver: Lack of prioritisation of different animal disease control and policy measures.

Problem: Sub-optimal allocation of resources for disease control.

As described above, the CAHP evaluation highlighted the absence of a clear system for prioritising resources for animal health policy interventions, such as categorisation of animal diseases and animal-related threats, (or reliable scientific grounds for such categorisation). This means that resources have sometimes been allocated on short-term, political or crisis-driven grounds, which do not fully reflect evidence based on scientific risk assessments and cost-benefit analysis. The management of less high-profile diseases might therefore be de-prioritised as a consequence. This sub-optimal allocation of resources for disease control under the current system could lead to more negative impacts of animal diseases than if resource allocation were optimally prioritised.

In many cases, the existing legal framework is too rigid and cannot adapt to new developments, including new scientific developments. The AHL Steering Group mentioned certain examples of these problems in their discussions in July 2009, for example: the rules on swine vesicular disease, which they felt to be disproportionate to the risks the disease poses; and protective measures for Newcastle Disease, which they felt to be outdated.

A bluetongue case study is outlined in the box below to illustrate a short term crisis-driven allocation of resources.

Bluetongue disease

Bluetongue is an insect-transmitted disease which appeared in North-Western Europe for the first time ever in summer 2006 when a virus strain, probably originating in sub-Saharan Africa, appeared in the Netherlands. That summer was exceptionally warm and these unusual climatic conditions may have exacerbated the conditions for the virus to flourish. That year 2,000 farms were affected, and in the following year 60,000 farms were affected, from the UK to the Czech Republic. Infections caused high mortality in sheep and goat populations.

In Belgium it is estimated that the mortality rate in 2007 amounted to one sixth of the national sheep and goat population. Economic losses in the Netherlands were estimated at €130 million in 2006 and 2007. In 2007, a BTV-8 outbreak in France was estimated to cost €1.1 billion. Losses there were largely due to the inability to trade cattle on the international market.

In the EU in 2008, a total of 45,000 outbreaks were reported. That number dropped to 1,118 in 2009 and only 120 in 2010. The success is credited primarily to the vaccination campaigns in the MS. A co-financed EU programme was adopted, initially funded by the "emergency fund", and later by annual programmes in all affected areas. This appears to be the main factor leading to the near-disappearance of the disease in the EU in 2010.

It has been argued that a more preventative approach to Bluetongue could have prevented much of the mortality and costs of the disease that the emergency measures required.

2.2.2.2. Poor coordination of animal disease surveillance

Driver: Lack of coordination between different surveillance systems and actors.

Problem: Sub-optimal use of surveillance to reduce the risk and impact of disease outbreaks.

Animal health surveillance is an essential tool to detect and control animal diseases, to monitor disease trends, to support claims for freedom from disease or infection, to provide data for use in risk analysis, for animal and/or public health purposes, and to substantiate the rationale for sanitary measures. Therefore, surveillance is a key element of any animal health policy that gives priority to a preventive approach, early detection and quick response.

Animal disease surveillance is one of the cornerstones of Pillar 3 of the AHS 2007-2013. Several activities (as noted above in section 1.7) have been carried out to identify the main challenges for surveillance and how they could be addressed:

- The current picture of animal disease surveillance in the EU is rather complex and the purposes or objectives of surveillance systems are not always sufficiently clear in current legislation (for example, there are surveillance systems which are EU harmonised vs. those not harmonised; compulsory vs. voluntary; surveillance in free areas vs. monitoring in not-free areas; EU co-financed vs. not EU co-financed; active vs. passive; farmed animals vs. wildlife and so on). It can therefore be difficult for stakeholders and competent authorities to understand their roles and responsibilities.

- The current surveillance systems may not be sustainable, as they do not necessarily make best use of available resources, nor optimally set priorities; so the affordability, sustainability and communication of surveillance activities need to be addressed. Support and engagement of the veterinary authorities and stakeholders, in particular farmers and trading partners, is essential and should be actively sought.

During the stakeholder consultation, 67.3% of respondents replied 'agree' or 'strongly agree' to the proposals to improve animal health surveillance. Full details are in part 2.6 of Annex V. Stakeholders suggested that the surveillance should be developed in partnership with them. Some have asked for a cautious approach in introducing surveillance network in order not to be too prescriptive.

2.2.2.3. Insufficient harmonisation of EU legislation with international standards

Driver: All MS are members of the OIE, so EU legislation should aim to better align with the existing OIE Health Codes for the sake of consistency with international trade rules and competitiveness of the EU farming industry.

Problem: In certain respects, convergence of standards represents a trade-off with animal health standards, but lack of convergence may lead to lack of competitiveness and even international trade disputes.

MS are members of the OIE and as a result should align their rules to the existing OIE Code. As such the standards of the OIE Health Codes should be reflected in EU legislation. Some current differences in EU legislation and OIE standards are set out in the box below.

The potential problem that arises from these differences is in the difficulty of achieving the optimal balance between aligning with OIE standards and maintaining EU health standards. This amounts to a trade-off between maintaining good relations with third countries, hence maintaining the competitiveness of the EU farming industry and avoiding potential trade disputes; and maintaining current animal health standards within the EU.

During the stakeholder consultation, 82.3% of respondents replied 'agree' or 'strongly agree' to the proposals to aligning EU standards with international standards (while not lowering EU standards) and to promoting EU standards in international fora, particularly the OIE.

Whilst EU trade and import legislation generally reflects OIE standards, sometimes there are differences. For example: - The OIE only carries out a paper evaluation as the basis for determining disease-free countries or zones. The EU does not consider this sufficient and generally carries out its own on-the-spot inspections before granting its trading partners this status. - The EU has its own level of protection for certain imports, based on scientific risk assessment, which is often higher than that which can be achieved solely by applying OIE standards or guidelines. An example is that the EU does not accept that the import of bone-in beef from a country carrying out vaccinations against foot and mouth disease is safe, whereas under certain conditions this would be possible under the OIE code. - The EU can act faster and indeed can be more flexible than the OIE in certain instances, such as in recognising different regions of a country or reinstating disease-free status following a satisfactory outcome of an inspection by the Food and Veterinary Office. - The definition of certain disease incubation periods or other time intervals and the approaches to evaluating competent authorities for animal health is different in OIE and EU standards. - There are differences in veterinary roles and standards as highlighted earlier. - Diagnostic tests in EU legislation do not always mirror the prescribed tests in the OIE manual.

2.2.2.4. Emerging, re-emerging and exotic diseases are not duly considered in current legislation

Driver: Lack of flexibility and appropriate tools to respond to, control and monitor emerging and exotic animal diseases.

Problem: Potential for larger scale and more frequent exotic disease outbreaks.

Public authorities and animal keepers know less about diseases which are not commonly present in the EU (typically known as exotic diseases) or are currently unknown (emerging diseases), than about diseases which are endemic in the EU. This means that MS and the EU have lower preparedness for dealing with outbreaks of exotic or emerging diseases. This can contribute to larger scale outbreaks of exotic diseases than if there was more adequate crisis-preparedness.

General EU measures for the control of certain animal diseases are laid down in Directive 92/119/EEC but these measures refer only to a limited list of emerging and/or exotic diseases for the EU and some of these measures do not prescribe the right tools to deal with certain exotic diseases. The rigidity of current rules limits the possibilities for the EU to play a more proactive role to prevent the spread and introduction of such diseases or to react in the event of a new animal disease. This could lead to delays in taking the appropriate measures to control them. In addition, past crises have shown the need to put in place clear and flexible rules for controlling and monitoring animal diseases that can be adapted to every conceivable situation and to varying regional factors. A good example is that of bluetongue, which was outlined in 2.2.2.1 above. Other examples were highlighted by the AHL Steering Group in their meeting in July 2009 for which they felt the existing legislation is too rigid and the EU relatively unprepared. These included Rift Valley Fever, and the rules for African Horse Sickness.

During the stakeholder consultation, 86.1% of respondents replied 'agree' or 'strongly agree' to the proposals to reflect emerging diseases in the AHL and to update certain disease control directives that are outdated or disproportionate. Full details are available in 2.10 of Annex V.

2.2.3. Insufficient focus on disease prevention

Freedom from animal diseases is widely considered to be a global public good, as it protects the health of animals and public health as highlighted in the "One World – One Health" concept developed by the WHO (World Health Organisation), OIE (World Organisation for Animal Health) and FAO (Food and Agriculture Organisation)[30]. Its importance is not limited to the rural economy but impacts on the whole of society. Animal diseases and related control measures can be costly to the livestock sector, and to competent authorities which currently cover most of the costs of crisis response. Additionally, freedom from certain animal diseases is a necessary condition for animals and animal products before they are traded within the EU and with third countries.

While animal health crises will always occur, the CAHP evaluation highlighted the need to focus more on disease prevention and rapid and effective risk management in order to reduce the incidence and scale of animal disease outbreaks. Recent work to put in practice the "One World – One Health" concept clearly show that the emphasis is shifting away from crisis response to building the systems and capacity to prevent and respond more effectively to future outbreaks of diseases.

The issues identified below are all problems caused by a mixture of both the content and implementation of existing legal powers; and because legal powers to provide an overall coherent view of all animal diseases are lacking.

2.2.3.1. Poor coordination of animal disease surveillance and monitoring

Driver: Lack of coordination between different surveillance systems and actors.

Problem: Sub-optimal use of surveillance to reduce the risk and impact of animal disease outbreaks.

As noted above in 2.2.2.2, surveillance is an essential tool to detect and control animal diseases. Its present sub-optimal use means the EU's ability to prevent disease outbreaks before they occur is not at its full potential. The improvement of surveillance systems is widely supported by stakeholders, as noted above.

2.2.3.2. Insufficient on-farm biosecurity measures to prevent outbreaks on farms and in the farming industry

Driver: Lack of comprehensive rules on farm biosecurity measures to reduce impact of disease outbreaks.

Problem: Inefficient use of biosecurity on-farm and in the farming industry, and increased risk of disease outbreaks.

Farmers (animal keepers in general) are often the best placed persons to prevent and detect animal diseases. Currently, very few mechanisms exist at EU level that actively encourage animal keepers to take preventive disease measures. Mechanisms to achieve on-farm biosecurity at other levels within the EU are mainly voluntary or industry-led schemes, which typically achieve a lower uptake than statutory measures.

The lack of biosecurity measures is driven by two factors:

- Many farmers and animal keepers lack sufficient information about biosecurity measures they could implement. In particular they are unlikely to be aware of the costs of implementing biosecurity measures compared to the benefits of reduced animal diseases. This can lead to farmers implementing fewer biosecurity measures than would be beneficial to them (because the on-farm benefits would exceed the implementation costs). This can lead to a lower level of biosecurity than is optimal and a higher risk of on-farm disease outbreaks.

- With optional or voluntary biosecurity schemes, farmers can choose the level of on-farm biosecurity they implement. Without specific mandates or incentives to take into account the wider benefits (public benefits) of their biosecurity measures, farmers are unlikely to implement additional measures above those that benefit them directly (private benefits). For example, certain measures might reduce the likelihood of disease outbreaks spreading to other farms and therefore lead to an overall lower cost of disease to society as a whole. So farmers implement on-farm biosecurity measures based on the private benefits they receive on their farm, not fully taking into account public benefits to others or to wider society. This also leads to a lower level of biosecurity than is socially optimal and a higher risk of on-farm disease outbreaks spreading to other farms.

Still very few mechanisms, regulatory or not, exist to rate holdings with respect to their level of biosecurity within the EU. Those mechanisms that do exist do not recognise or assist those who wish to achieve higher than minimum (additional) standards (and may even create an uneven playing field for them). More data and analysis on this issue are available in Annex XI.

During the stakeholder consultation, 75.8% of respondents replied 'agree' or 'strongly agree' to the proposal of a legal framework introducing voluntary biosecurity on farms, and a minimum criteria for biosecurity measures (adapted to local circumstances). Detailed stakeholder views and conclusions are presented in Points 2.5. and 3.5 of Annex V.

2.2.3.3. Applicability and acceptability of the current vaccination strategy for control of animal diseases

Driver: The willingness of MS and stakeholders to use vaccination as a tool to control animal disease outbreaks, which is often linked to the availability and reliability of vaccines and differentiating diagnostic tests.

Problem: Sub-optimal level of use of vaccination for major animal diseases, increasing the impact of animal disease outbreaks, when they occur.

The use of vaccination to control major epidemic diseases has been the subject of very intense debate in the EU in the last twenty years. The main reasons why vaccination is not often applied by MS are the poor availability of certain vaccines and associated DIVA[31] tests; concern over potential trade blocks (of imports of vaccinated animals and/or products of vaccinated animals) by third countries; and consumer perception in the EU.

Nevertheless, it is widely agreed that in many cases vaccination could be used as a means of preventing animal diseases. But more importantly, vaccination could also be the best means of preventing and minimising negative impacts of animal diseases once they occur by preventing further spread of disease. The principle 'vaccination is better than unnecessary culling' was agreed during the creation of the AHS and its Action Plan.[32] In order to address the issue of availability of vaccines, a task force of experts was created to assist the Commission in the development of an expert policy paper[33] on EU vaccine/antigen banks for major animal diseases. The main conclusions reached in this process were:

- For most of the relevant infectious diseases, existing legislation regarding emerging vaccination should be amended so that vaccination becomes a more realistic and viable option in the event of a crisis.

- The mechanisms of accessing the vaccines/diagnostics have to be clarified. A procedure should be established to assure guaranteed supply.

A detailed analysis of vaccination policy and further data are presented in Part 1 of Annex VII. Stakeholders' views concerning vaccination are collated in Point 2.15 of Annex V. As referred to previously, the questionnaire and a summary of the outcome of this consultation with the CVOs can be found in Part 2 of Annex VII to this document.

This approach is widely supported by stakeholders – there is wide agreement that vaccination should be used in a flexible way, taking into account its advantages and disadvantages and encouraged where it is strategically sensible to do so.

2.2.3.4. No consistent provisions for training on animal health for people dealing with animals

Driver: Animal keepers often have a lack of access to information and training on animal health.

Problem: Potential for sub-optimal on-farm animal health measures to prevent and control animal diseases, with increased potential for disease outbreaks.

Current EU legislation focuses on training for people dealing with or handling animals in dealers’ premises, assembly centres and during transport. However, there are no provisions for training of people dealing with animals at farm level in order to achieve a higher level of awareness of the potential health, social and economical impacts that animal diseases might have and the measures that they themselves can implement to prevent them. This potential lack of awareness can lead to poor implementation of the rules, and the risk of animal health and welfare problems, such as late reporting of animal disease outbreaks. This can result in measures for controlling the diseases being delayed and therefore have an increased impact.

During the stakeholder consultation, a voluntary approach to better training was regarded as the most adequate solution by the majority of stakeholders (see Point 2.2. in Annex V). However, a significant share preferred that training should be compulsory in the AHL, expressing at the same time concerns on funding. The importance of flexibility to adapt provisions to differing circumstances was highlighted by a majority of stakeholders.

2.2.4. Rules for intra-EU trade of live terrestrial animals are sub-optimal

Whilst the previously described problems fit under the thematic headings, the steering group highlighted problems with intra-EU trade that fell under several of these different categories. Therefore rather than addressing these thematically, the issues related to trade have been grouped together. The issues here are areas where the existing law is not optimal, but any proposals for better coherence would not necessarily expand the EU's powers further.

2.2.4.1. Current animal health rules for intra-EU trade

Driver: Current animal health rules for intra-EU trade for live terrestrial animals are not always proportionate to the animal health risks posed by movements.

Problem: Current rules limit the single market for live terrestrial animals, and the administrative burden for traders and competent authorities is not always proportionate to the level of animal health risk posed by different types of movements.

Current animal health provisions for commercial movements of live terrestrial animals between MS are largely based on the "intra-EU trade" concept. Under this approach, before live terrestrial animals are moved between MS they must fulfil certain animal health requirements established in the EU legislation. Veterinary checks and examination are required to ensure the animal meets these requirements and a certificate is issued before the movement is allowed. A notification of the movement must be made in national identification and registration databases and into the TRACES[34] system.

The current EU legislation allows MS to maintain, to a certain extent, animal health rules on national movements in live animals, provided that these national rules comply with the relevant provisions on the control of diseases that are regulated at EU level.

The current system with different requirements for movements within the MS to that across MS does not fit well with the concept of the single market. Although border veterinary checks between MS were abolished long ago and certain certification rules for the EU movements are more straightforward than those for international trade; the movements system still contains different market approaches to trade within MS than for trade across MS.

Furthermore, this system was criticised during the CAHP evaluation for being complicated, expensive for operators and burdensome from an administrative perspective for operators and competent authorities, and because this administrative burden was not proportionate to the health risks posed by such movements. This is most obviously the case for movements of animals between two MS with an identical health status (in an extreme example, even movements across a border between holdings of the same owner, or cross-border transhumance) and movements of animals for direct slaughter. These are largely known in the EU, for example between Germany and the Netherlands; Belgium and Luxembourg; Austria and Germany; in the island of Ireland; Slovenia and Austria; France and Italy; the special case of moving reindeer between Finland and Sweden; and many others. In these cases, an argument can be made that the health status guarantees for the relevant animals may not need to be so demanding.

However, in some cases the measures may be proportionate to the animal health risk posed, for example when animals or their products are moved between holdings or zones of a different health status, or for specific categories of animals, where a health status is of particular or specific relevance and where appropriate health guarantees have to be provided.

A balanced solution ought to be sought for the health risks involved in a particular movement, reducing some complexity of the procedures and costs attached to it and preserving a transparent and simple system that can be easily applied in practice. More data, a special analysis and examples on this issue are available in Annex VIII.

2.2.4.2. Duplication of procedures and electronic certification

Driver: Lack of harmonisation of procedures and certification for intra-EU movements.

Problem: Current system is difficult to use and unclear, with a high administrative burden for users through duplication of procedures.

The diverse information systems on animal health within the EU and in the international framework (TRACES and ADNS in the EU; WAHIS-WAHID for the OIE; and national databases for animal identification and registration) sometimes create multiplication of effort for MS, as the same notification has to be entered in several databases. In addition, despite the high number of information systems, they do not provide information fit for purpose for EU and MS risk managers to support decision making on disease prevention and control measures.

Furthermore, electronic certification could be considered as an option to simplify veterinary procedures greatly. The TRACES system could enable electronic certification and so simplify the process, but a legal basis for doing this is currently lacking.

The collection, processing and use of information on animal health does not function optimally and does not deliver its full potential value.

For example, the CAHP evaluation recommended exploring further the possibility of developing integrated electronic systems that could lead to better traceability and a reduction of administrative burdens for operators. However, there would be considerable technical and other difficulties to be overcome. Prior to proceeding, such integration efforts would have to be subject of a detailed technical feasibility study/impact assessment, as there are risks in integrating the electronic systems for EU procedures applied in animal movement (e.g. data overload, security issues) that require further technical analysis.

2.2.4.3. Concept of compartmentalisation is not widely recognised in EU law

Driver: Compartments used in some production systems are not widely recognised in EU law.

Problem: Legislation does not reflect lower disease risks of compartments, so compartmentalisation is not well incentivised in the current legal framework.

In the context of better biosecurity a new concept of "compartmentalisation" was developed at international level and described in the OIE Health Codes. A compartment is a group of one or more animal establishments which are subject to a common biosecurity management system, with a distinct health status for a specific disease or diseases which require surveillance. These control and biosecurity measures are usually applied to facilitate international trade.

In practical terms this implies that a compartment might be considered as a homogeneous production unit with respect to health status, veterinary control measures and trade, as all establishments in the compartment have the same distinct status, which is known throughout the compartment.

This concept has not been introduced into the EU legislation except in Directive 2005/94/EC related to the measures for Avian Influenza, and Directive 2006/88/EC related to aquaculture animals. It could also be extended to other diseases and used by the MS for the purposes of international and intra-EU trade, and for better control and eradication of animal diseases.

There is currently a lack of legal powers to provide an overall coherent approach for compartmentalisation for all relevant diseases.

2.3. Who is affected by the current policy?

The current policy and the issues associated with it as identified above particularly affect stakeholders involved in keeping live animals and in the production of, trade in, and import or export of live animals, animal products and products of animal origin. Non-commercial animal keepers and holdings such as pet owners, zoos, backyard farmers, and hobby farmers are also affected.

Under present legislation, animal keepers have a degree of responsibility for prevention and control of animal diseases. In general, non-professional animal keepers usually have a lower level of biosecurity and awareness of hazardous practices compared to the professional sector.

Competent authorities in the MS in charge of implementing and controlling the implementation of animal health rules are also a set of key stakeholders.

Trading partners and competent authorities in third countries are affected by the EU's import conditions for live animals, animal products and products of animal origin.

Veterinarians, both official (state) or private, other veterinary professionals, technicians and the wider veterinary industries also play a key role in the delivery of EU animal health policy.

2.4. The right and justification for EU action 2.4.1. Treaty basis

Articles 43, 114 and 168 of the Treaty on the Functioning of the European Union (TFEU) provide the legal basis for the EU legislative measures on animal health, as they are an essential part of EU agricultural, public health and consumer protection, trade and single market policy.

- Article 43 provides the basis for the EU legislative measures on the Common Agricultural Policy. This article also became the basis for veterinary legislation as the CAHP is considered from a legal perspective to be part of the Common Agricultural Policy, so adopting the same legislative and administrative procedures.

- Article 114 provides the legal basis for the establishment and functioning of the internal market and the approximation of provisions laid down by the law, regulation or administrative actions in this respect.

- Article 168 on health protection refers to the protection of human health from all causes that may damage it, including those related to animal health. The legal basis for veterinary and plant health measures directly aimed at protecting public health were adopted under the co-decision procedure as a result of this article.

2.4.2. Subsidiarity test

Necessity test - Why can the objectives not be achieved by MS?

In very general terms, good animal health generates not only private benefits for the particular animal keepers and owners concerned with individual animals, but is a public good with wider societal benefits. The transmissible nature of many animal diseases means that a common approach, rather than a series of individual actions, is likely to have the greatest overall benefits.

The value of a harmonised EU approach to the control of major transmissible diseases has been confirmed by judgements of the Court of Justice and by reports of the Court of Auditors, the farming, agricultural and food industries, the European Parliament, and other stakeholders; with the Commission's role in policy making becoming increasingly accepted both within the EU and internationally.

Veterinary legislation at EU level has led to harmonised rules which apply to all MS and has replaced a complex web of national and regional rules. This harmonisation has helped to reduce the administrative burden for operators, traders, veterinarians and veterinary-related industries.

A harmonised animal health policy has played a key role in the establishment of the single market, facilitating intra-EU trade in animals and animal products (meat, milk, etc.) by setting up harmonised animal health conditions and promoting the success of the CAP. The development of harmonised EU animal health standards has progressed in parallel with the development of intra-EU trade and trade with third countries.

The necessity of continued EU level action is demonstrated by the fact that if MS were to introduce national rules including possible restrictive measures in the event of an animal disease outbreak, serious disruption would likely occur to trade in animals, animal products and products of animal origin as well as to related agricultural and industrial activities such as farming and slaughter. This could also have consequent effects on exports of live animals due to the credibility of EU measures in third countries being jeopardised, while in the long run the EU would lose the power to negotiate at international level.

Animal disease outbreaks that have occurred in the past have shown that MS may be subject to internal pressures which might not allow them to adopt the most effective disease control measures. This problem occurs particularly when certain outbreak scenarios are not provided for in EU legislation. In this situation, there could be increased spread of animal disease and additional costs and losses for the farming, agricultural and food industries as well as costs for MS and the EU.

Added value test - Can objectives be better achieved by the EU?

The benefits of harmonised rules for the prevention, notification, control and eradication of animal diseases at EU level have been demonstrated during animal disease outbreaks in recent times. The response to these crises showed the EU's capability to react quickly, limiting the spread of diseases and minimising their impacts. This was largely due to the harmonised approach to disease control, including providing financial compensation for the losses on farms due to disease eradication measures. The current system also enables the development of sustainable surveillance and monitoring programmes by providing co-financing at the EU level. In the past, the EU harmonised approach to disease control has enabled the EU to defend the interests of its MSs on the international scene. For example, the EU has been able to negotiate the regionalisation approach for disease control measures with several third countries on many occasions. This approach looks at the evidence for where diseases actually occur, treating regions individually according to risk, not simply a single country or territory as a disease-ridden or disease-free block. This has meant that in the case of a disease outbreak in a part of the EU, other parts of the EU have been able to continue to trade without restrictions with third countries. These benefits of these negotiations could not have been achieved without the EU acting as a coherent block.

The main tools that have enabled the achievement of the benefits mentioned above are:

· The establishment of an enhanced system for animal identification and traceability and of TRACES,

· The functioning of the Animal Disease Notification System (ADNS),

· Veterinary Fund expenditure.

Furthermore, the AHL envisages the introduction of a disease categorisation and prioritisation exercise for evaluating the value of EU intervention in relation to animal diseases and related threats. This exercise would categorise animal diseases according to their impact on the economy, trade, human health, society, animal welfare and the environment. It would also take into account the feasibility of implementing successful control measures. Categorisation is a risk management exercise which would be compulsory prior to determining:

- whether a disease should be dealt with at the EU level, by MS and/or at the private level;

- if at EU level, the nature of EU intervention (such as legislation, enforcement regulation, eradication, awareness, training, cooperation or research).

The AHL aims to establish a general framework for the prevention, control and eradication of animal diseases. This framework will be built on outcome-based rules, avoiding over-prescriptiveness, and leaving room for MS to regulate or set more detailed legislation when necessary, so providing for the flexibility to adapt the rules to national, regional or local circumstances.

On the other hand, rules on trade must necessarily have a certain level of detail and precision to reduce the risk of different implementation practices by operators and competent authorities and subsequent distortion of competition and possible reduction in the coherence of the approach to tackling disease.

Boundary test - Impact on other geographical areas and other policy areas

Trans-boundary animal diseases are a permanent threat for livestock keepers and MS as they can have major economic implications for both the private and public sectors. They can easily spread from one country to another and can reach pandemic proportions. Wild animals can play an important epidemiological role in the transmission of animal diseases and their movements are extremely difficult to control or restrict between MS (for example, the spread of avian influenza through wild birds). Global trade and movements of people and goods increase the risk of rapid disease spread over greater distances. For this reason control measures and harmonised surveillance systems are needed at EU level. Past evidence of cases where MS failed to control the spread of the disease (in the absence of an EU-wide framework) show that such cases may lead to significant cross-border impacts in terms of animal health and possibly also public health.

The EU, as the largest global importer of food and animal feed, needs to protect itself against the possible introduction of exotic animal diseases and public health risks through the trade in live animals and animal products. The EU has harmonised rules for imports of live animals and animal products. Their objective is to make sure that the same principles for import are applied in all MS in order to prevent animals carrying transmissible diseases that are dangerous for livestock or humans from entering EU territory.

All types of micro-organisms (viruses, bacteria, parasites) causing animal diseases are covered by this impact assessment. Invasive alien species other than micro-organisms, but also causing diseases are not covered by this impact assessment. This issue is currently being assessed by DG Environment and will be addressed separately to the envisaged animal health law's scope of animal health and pathogens. DG Sanco has worked closely with DG Environment to ensure a joined-up approach.

The new AHS for the EU endorses the concept of the OIE and the World Bank of animal health as a "global public good", which means that good animal health benefits everyone. It accepts that the functioning of animal health services should be a public investment priority. The implementation of the strategy requires public authorities in the EU to take a common approach. Furthermore, the roles and responsibilities of all actors have to be clear and consistently enforced throughout the EU for the sake of better prevention of animal diseases.

In light of these different elements, EU action is justified, as it is clear that MS cannot achieve this satisfactorily acting alone and that the EU would achieve a consistent approach more effectively and efficiently.

3. Objectives

Having established in section 2 above that there are a number of aspects of EU animal health policy that could be improved, and that the EU has both the basis to act and can add value by doing so, we now turn to the objectives of what animal health policy is actually trying to achieve.

The EU as a whole is working towards the agreed objectives of Europe 2020[35]. Animal health objectives should uphold these crucial overarching objectives by reducing the risk of the negative economic, social (including public health) and environmental impacts of poor animal health or animal disease outbreaks; and consequently by supporting the economic security and success of animal keepers, particularly farmers.

It is worth reiterating here that animal health objectives do not stand in isolation. Good animal health is a critical factor in ensuring the viability and sustainability of the internal market; and particularly of the food sector, which is the largest single economic sector in the EU. There is inevitably overlap and interaction with other areas of policy, such as animal welfare, food safety, animal nutrition, veterinary medicines, and official controls, but also with wider agricultural and environmental issues.

3.1. General objectives

The general objectives of EU animal health policy are outlined in the EU AHS 2007-2013, and are:

- to ensure a high level of public health and food safety by minimising the incidence of biological and chemical risks to humans;

- to promote animal health by preventing/reducing the incidence of animal diseases, and in this way to support farming and the rural economy;

- to improve economic growth/cohesion/competitiveness assuring free circulation of goods and proportionate animal movements;

- to promote farming practices and animal welfare which prevent animal health related threats and minimise environmental impacts in support of the EU Sustainable Development Strategy.

These general objectives demonstrate that the basis for EU action is wider than simply preventing public or animal health problems from arising or ensuring the economic security of farmers. The scope of any new measures will need to encompass not just kept animals (including production animals, animals used for work, sport, recreation or display, companion animals and animals used in research); but also, to an extent, wild animals, where their poor health has the potential to jeopardise any of these objectives.

3.2. Specific objectives

The specific objectives of the new legislation are:

- to establish a single, simplified, transparent and clear regulatory framework that sets out systematically the objectives, scope and principles of the regulatory intervention; based on good governance and compliant with international (e.g. OIE) standards; focusing on long-term preventative measures and working together with all relevant stakeholders;

- to introduce overarching general principles allowing a simplified legal framework in order to be prepared for the new challenges, i.e. to enable quick reaction in case of emerging diseases; whilst ensuring the same quality of reaction as provided for in current legislation.

- to ensure consistency amongst the horizontal principles of the legislation in the field of animal health, animal welfare and food safety policies as well as broader EU policies on climate change and sustainability;

- to reduce the economic and social impact of animal diseases on public health, animal welfare, economy and society as far as possible by enhancing disease awareness, preparedness, surveillance and emergency response systems at national and EU level;

- to ensure the smooth functioning of the internal market of animals and animal products, with a high level of protection of animal health and public health and supporting the objectives of Europe 2020.

3.3. Operational objectives:

- to integrate the new prevention-driven and incentive-oriented approach into the core of animal health policy;

- to provide for a clear and balanced distribution of roles and responsibilities between competent authorities, EU institutions, the farming sector, animal owners and others;

- to introduce disease categorization as the basis for EU intervention;

- to provide for effective mechanisms for a rapid response to disease events, including new challenges, such as emerging diseases;

- to ensure effective emergency preparedness and early response to animal diseases threats and zoonoses, including use of vaccines as appropriate;

- to introduce simplified procedures, wherever possible for technical and other reasons, taking into account the specificity of small farmers and micro businesses;

- to ensure that the new legal framework provides enough flexibility to adapt smoothly to future scientific and technological developments;

- to reduce the risk of trade disruption by seeking an appropriate level of convergence with relevant international standards, while ensuring a firm commitment to high standards of animal health.

4. Options

In order to solve the problems identified and achieve the above-mentioned operational objectives, we have considered four policy options below. It is worth noting here that the development of any new measures will need to have taken evidence into account (where it exists), particularly scientific evidence; but also social, economic and ethical considerations.

Option 1: Do nothing (i.e: continue with current policy)

Option 2: Simplification of existing legislation with no major content or policy changes

Option 3: Existing legal framework with more self-regulation

Option 4: A new flexible general legislative framework on animal health issues, based on achieving certain animal health outcomes

Option 5: A new prescriptive legislative framework on animal health issues, based on setting specific processes and standards for animal health policy.

4.1. Option 1 - Do nothing

Current animal health rules would remain, with technical updates and adaptations made as necessary but without a horizontal framework establishing overall strategic objectives. Where possible, existing regulatory tools would be used to tackle problems identified.

4.2. Option 2 – Simplification of existing legislation with no major content or policy changes

This option would enable the bringing together of all the existing Animal Health Legislation into one large piece of legislation, but would not make any significant changes to the content of the legislation itself. Minor changes would only be made as circumstances required, and in order to comply with the Lisbon Treaty. This would slightly improve clarity of the legal framework but would not solve the problems highlighted in the AHS and in Section 2 of this document.

4.3. Option 3 – Existing legal framework with more self-regulation

This option would complement the current animal health policy and existing legislation with additional initiatives of a non-regulatory nature. Under this option, the use of self-regulation tools[36] such as the drafting of guidelines by the Commission, or by stakeholders with the Commission and/or MS acting as facilitators, would be envisaged in order to cover some of the gaps and inefficiencies of the current animal health legislation. These guidelines would focus on different aspects of day-to-day management at the farm level that may be challenging and would encourage best practice. They would take into account the risks associated with certain types of production and would explain how to contribute to disease prevention and implement more effective biosecurity and surveillance measures. As now, MS would have the ability to regulate certain issues at national level. Legislation would be updated individually as necessary to comply with new requirements (such as the new decision-making processes following the introduction of the Lisbon Treaty), or with technological developments.

4.4. Option 4 - Flexible general legislative framework on animal health issues (AHL)

Under this option, a new legal framework would set out the principles and objectives for animal health policy required to achieve desired outcomes. The outcomes, such as certain animal health and linked public health standards, would be agreed at EU level. However, the framework would be flexible to allow MS to set their own specific rules in certain cases to achieve these outcomes. It envisages that these specific rules would be based on veterinary risk assessment and cost benefit analysis to best suit particular situations in MS.

This general legislative framework of the AHL would not include detailed and specific legislative provisions such as particular disease control measures for specific diseases, specific identification and registration rules for each animal species, or specific measures on movements within the EU for particular species and so on. These specific measures would be laid down at a later stage by means of delegated or implementing acts under the procedure foreseen in Articles 290 and 291 of the TFEU. These acts would be subject to an Impact Assessment where appropriate.

4.5. Option 5 - Prescriptive general legislative framework on animal health issues (AHL)

Under this option, a new comprehensive legal framework would set out the principles and objectives of animal health. This framework would set specific standards for animal health rules and procedures which would be required across MS, with little flexibility for MS to adapt the rules to their differing circumstances. In this case the legal framework would be much more prescriptive and detailed but would cover more or less the same or similar content as the previous option.

Like option 4, this general legislative framework of AHL would likely not contain detailed and specific legislative provisions. These rules would be laid down at a later stage by means of delegated or implementing acts under the procedure foreseen in Articles 290 and 291 of the TFEU and subject to an im