Explanatory Memorandum to COM(2013)260 - Animal Health - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)260 - Animal Health. |
|---|---|
| source | COM(2013)260  |
| date | 06-05-2013 |
Animal health is a concern for all European citizens. This concern stems from the public health, food safety and food security aspects, which are related to animal health but also from the economic costs that animal disease outbreaks can trigger and the animal welfare considerations, including the implications of disease control measures on animal welfare.
At the same time, this proposal reflects the priorities of Smart Regulation i 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 by helping the sector to become more resilient due to active prevention measures and more flexible risk management.
The current EU animal health legislative framework involves almost 50 basic directives and regulations and some 400 pieces of secondary legislation, some of them adopted as early as 1964.
The Commission launched an external evaluation in 2004 to thoroughly review the outcomes of EU action of animal health, leading to a new Animal Health Strategy in 2007. A combination of circumstances made it imperative to re-evaluate our policy:
Ÿ The main elements of the existing policy were drawn up largely between 1988 and 1995 when we were still a Community of twelve Member States;
Ÿ New challenges have emerged. Diseases which were unknown a decade ago have appeared, while others, such as foot and mouth disease, bluetongue and avian flu, have recently presented new challenges, reminding us that they remain very serious risks;
Ÿ Trading conditions have also changed radically with the volume of trade in animals and animal products increasing greatly, both within the EU and with third countries; and
Ÿ Science, technology and our institutional framework have evolved substantially.
A number of problems have been identified in respect of the existing legislation. Some relate to the general policy approach, namely:
– The high complexity of the current Community Animal Health Policy (CAHP)
– The lack of an overall strategy
– An insufficient focus on disease prevention, with a particular focus on the need for increased biosecurity.
Others were related to specific problems with the functioning of existing legislation, particularly:
– Issues related to intra-Union trade in live animals.
Both general and specific problems are either rectified in this law, or will be rectified in its delegated and implementing acts.
The Animal Health Law is the legal framework to support the Animal Health Strategy for the EU, published in 2007. The general objectives as outlined in the Strategy are:
Ÿ to ensure a high level of public health and food safety by minimising the incidence of biological and chemical risks to humans;
Ÿ to promote animal health by preventing/reducing the incidence of animal diseases, and in this way to support farming and the rural economy;
Ÿ to improve economic growth/cohesion/competitiveness assuring free circulation of goods and proportionate animal movements;
Ÿ 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.
The specific objectives of this Animal Health Law are:
Ÿ to establish a single, simplified, transparent and clear regulatory framework that sets out systematically the objectives, scope and principles of 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;
Ÿ 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;
Ÿ 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, common agricultural policy and sustainability;
Ÿ to reduce the impact of animal diseases on animal and 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;
Ÿ 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.
The operational objectives of this Animal Health Law are:
Ÿ to integrate the new prevention-driven and incentive-oriented approach into the core of animal health policy;
Ÿ to provide for a clear and balanced distribution of roles and responsibilities between competent authorities, EU institutions, the farming sector, animal owners and others;
Ÿ to introduce disease categorization as the basis for EU intervention;
Ÿ to provide for effective mechanisms for a rapid response to disease events, including new challenges, such as emerging diseases;
Ÿ to ensure effective emergency preparedness and early response to animal diseases and zoonoses, including use of vaccines as appropriate;
Ÿ to introduce simplified procedures, wherever possible for technical and other reasons, taking into account the specificity of small farmers and micro businesses and releasing unjustified administrative burdens and costs, wherever possible;
Ÿ to ensure that the new legal framework provides enough flexibility to adapt smoothly to future scientific and technological developments;
Ÿ 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.
Legal 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. Veterinary measures directly aimed at protecting public health were also adopted under the co-decision procedure as a result of this article.".
This set of animal health legislation interacts with the 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).
The proposal is part of a package of four reviews relating to animal health, health of plants, quality of plant reproductive material and official controls of plants, animals, food and feed.
The revision of the official controls regulation enables official controls to be more consistently applied for the purposes of protection of animal health and links more coherently with animal health regulation.
Subsidiarity
Good animal health generates not only private benefits 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, will have the greatest overall benefits.
The value of the harmonised EU approach is widely accepted and has helped to reduce the administrative burden for operators, traders, veterinarians and veterinary-related industries. It 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 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. Also, taking into account the single market dimension, the failure to control a disease in one Member State, may severely affect the health status of the Union and jeopardise its export potential. 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.
The Animal Health Law establishes a general framework for the prevention, control and eradication of animal diseases. This framework is 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. Therefore the Animal Health Law tries to achieve the balance of proportional but necessary action.
Contents
- CONSULTATIONS
- BUDGETARY IMPLICATIONS
- Problem analysis
- Objectives of the proposal
- 2. LEGAL CONTEXT
- Consistency with other Union policies
- Relationship to other proposals in the package
- 3. SUBSIDIARITY AND PROPORTIONALITY
- Proportionality
- WITH INTERESTED PARTIES AND IMPACT ASSESSMENTS
- 5. ELEMENTS OF THE PROPOSAL
- Part II: Notification, Surveillance, Eradication Programmes, Disease Freedom
- Part III: Disease Preparedness, Awareness and Control
- Part IV: Requirements Concerning Registration, Approval, Traceability and Movements
- Part V: Entry into the Union and Export
- Part VI: Emergency Measures
- Part VII: Final and Transitional Provisions
Consultation process
This Animal Health Law 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) i 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.
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 i.
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[5], the Council[6] and the European Economic and Social Committee[7] welcomed this initiative. Subsequently, the Action Plan for the implementation of the Strategy[8] confirmed that 'the main objective of the Strategy is the development of an EU Animal Health Law'.
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.
Part I: General Rules
The Animal Health Law sets out general principles for good animal health in EU legislation. It brings together animal health measures for terrestrial and aquatic animals.
Part I also provides for the prioritisation and listing of diseases which are likely to have a significant impact. For the first time, this will enable Union resources to be systematically prioritised on a scientific and evidential basis.
The responsibilities of all the different actors having a key role in the safeguarding of animal health, such as operators, veterinarians, and pet keepers, are explicitly laid down for the first time. In particular, operators and animal professionals are now required to acquire a basic knowledge of animal health and related matters.
Part II clarifies the responsibilities for notification and surveillance including animal health visits. It clarifies the roles of operators, competent authorities and others as regards surveillance of the animal health situation in the Union. The new system allows for better use of the synergies between surveillance undertaken by the different actors in the field to ensure the most effective and cost efficient use of surveillance resources.
Another main change here is that compartments, permitted only for Avian Influenza related measures and in aquaculture at present, can now be used more widely. This introduces more flexibility into disease control measures, introducing the possibility of continuing movements and trade under certain circumstances, considered from a risk-based perspective.
Part III continues to require MSs to draw up contingency plans for dealing with certain diseases, and to practise their implementation.
The regulatory framework for vaccination is now explicitly and coherently provided for.
The rules for the use of antigen, vaccine and reagent banks are laid down.
Rules on control measures to be taken in the case of suspicion of or confirmed disease outbreaks of certain diseases are laid down, with little change to the existing system, which is considered to work well.
Part IV is split into three titles, with distinct rules for terrestrial, aquatic, and other animals. It is necessary to consider them separately because of their different production methods and epidemiology. The titles dealing with aquatic and terrestrial animals lay down measures which help to identify and trace animals and establishments. The traceability of animals is of crucial importance during a disease outbreak so that the epidemiology of the disease is understood and can be better controlled. These titles also introduce the possibility for more animals to be registered and traced through electronic means, promoting simplicity and better regulation, and reducing administrative burden through the use of technology. A third title on other animals is introduced only for possible future provision, should new threats emerge in relation to these animals.
Part V sets the standards and requirements for third countries sending animals, germinal products, products of animal origin and other material that may transmit animal diseases into the Union, in order to prevent diseases being introduced. It also sets out requirements for export. No practical changes are envisaged from existing legislation, which is considered to function well.
Emergency measures are a crucial part of disease management. Part VI lays down the procedures to be followed in case of emergency, ensuring a rapid and consistent Union response. Only a few practical changes are envisaged from existing legislation, which is considered to function very well.
The final and transitional provisions set out the national provisions, the conditions for adopting delegated acts, repeals, and other necessary legal provisions.
This proposal does not imply expenditures which are not already included in the financial statement of the common financial framework for food chain, animal health and welfare, and relating to plant health and plant reproductive material.