The European Parliament adopted by 570 votes to 63 with 19 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on Animal Health.

Parliament’s position in first reading following the ordinary legislative procedure amended the Commission proposal as follows:

Emphasis on prevention: Parliament was of the opinion that the regulation should establish: (a) rules for the prevention and control of animal diseases, which are transmissible to animals or to humans; (b) instruments and mechanisms to facilitate progress towards the declaration of disease-free zones and territories; (c) priority actions; and (d) the division of responsibilities in the area of animal health.

Measures taken should aim for (i) the effective functioning of the internal market, and food and feed safety; (ii) a reduction in the adverse effects on animal health, public health and the environment; (iii) reduction in certain diseases and risk factors leading up to diseases.

Biodiversity and the need to protect and conserve rare animal breeds, and to preserve genetic diversity should be taken into account.

Antibiotic resistance: Members also proposed that Member States should pay particular attention to antimicrobial resistance and ensure better access to professional training in this area when designing their national plans for the prevention and control of infectious animal diseases.

Member States should take certain criteria into consideration, particularly the use of veterinary medicine on human health, such as the detrimental effects of antimicrobial resistance, when determining whether or not to use veterinary medicinal products as disease prevention and control measures for a specific disease.

Listed diseases: Parliament introduced a table of diseases of terrestrial animals in an annex to the regulation. The Commission will be empowered to adopt delegated acts, taking due account of the opinions of the European Food Safety Authority, and after due public consultation with stakeholders and experts, concerning amendments to the listed diseases. 

Generally, Members felt that the existing system should be supplemented by strategic measures to monitor, prevent and control infectious animal diseases, including those not listed in this regulation (the most resistant to antibiotics). These measures should include a requirement for a good animal husbandry and responsible use of veterinary medicines.

Veterinarians or aquatic animal health professionals should immediately notify the competent authority in the event of an outbreak or suspicion of an outbreak of a listed disease. Doctors should immediately inform the competent authority of any sign of a zoonotic disease.

Border controls: Member States should, with technical assistance at Union level as regards listed diseases, ensure that appropriate preventive, risk-based biosecurity measures were applied along their external borders, in cooperation with the competent authorities of the third countries concerned.

Animal welfare and animal health: Parliament stressed the well-established link between animal welfare and animal and public health. They made references to animal welfare in the text, since this has an influence on animal health such as when part of biosecurity measures. Moreover, an explicit reference was made to Article 13 of the Treaty on the Functioning of the European Union, in order to emphasise that animals are sentient beings.

Members also wanted to reiterate the importance of good animal husbandry and the requirements arising from EU legislation on animal transport. With respect to the movement of live animals, the Regulation should be amended to the effect that the deciding factors should be the journey time and the number of assembly operations, not whether the journey crosses a national border.

Stray animals: by 1 January 2018, Member States should introduce a registration requirement for dogs. The Commission should submit by 31 July 2019 a report on the experience of the Member States with the registration and identification of dogs, with particular reference to stray animals.

Urgent measures: to tackle diseases that have a major impact on public health, agricultural production or animal welfare and health, the Commission must be empowered to adopt urgent measures. However, Members insist that both Parliament and Council must have proper scrutiny over the measures adopted and the possibility of repealing them if necessary.

Union reference laboratories: the Commission should designate Union reference laboratories for illnesses for which, owing to their impact on health or the economy, this is necessary to achieve the objectives of the Regulation. Member States should designate one or more national reference laboratories for each Union reference laboratory designated.

The Committee on Agriculture and Rural Development adopted the report by Marit PAULSEN (ADLE, SE) on the proposal for a regulation of the European Parliament and of the Council on Animal Health.

The committee recommended that Parliament’s position in first reading following the ordinary legislative procedure should amend the Commission position as follows:

Emphasis on prevention: Members felt that the regulation should be on the prevention and control of animal diseases which were transmissible among animals or to humans.

The regulation should establish: (a) rules for the prevention and control of animal diseases, which are transmissible to animals or to humans;  (b) instruments and mechanisms to facilitate progress towards the declaration of disease-free zones and territories; (c) priority actions; and (d) the division of responsibilities in the area of animal health.

Measures taken should aim for (i) the effective functioning of the internal market, and food and feed safety; (ii) a reduction in the adverse effects on animal health, public health and the environment; (iii) reduction in certain diseases and risk factors leading up to diseases.

Biodiversity and the need to protect and conserve rare animal breeds, and to preserve genetic diversity should be taken into account.

Antibiotic resistance: Members proposed that Member States should pay particular attention to antimicrobial resistance and ensure better access to professional training in this area when designing their national plans for the prevention and control of infectious animal diseases.

Member States should take certain criteria into consideration, such as the detrimental effects of antimicrobial resistance, when determining whether or not to use veterinary medicinal products as disease prevention and control measures for a specific disease.

Generally, Members felt that the existing system should be supplemented by strategic measures to monitor, prevent and control infectious animal diseases, including those not listed in this regulation (the most resistant to antibiotics). These measures should include a requirement for a good animal husbandry and responsible use of veterinary medicines.

Animal welfare and animal health: Members stressed the well-established link between animal welfare and animal and public health. They made references to animal welfare in the text, since this has an influence on animal health such as when part of biosecurity measures. Moreover, an explicit reference was made to Article 13 of the Treaty on the Functioning of the European Union, in order to emphasise that animals are sentient beings.

Members also wanted to reiterate the importance of good animal husbandry and the requirements arising from EU legislation on animal transport. With respect to the movement of live animals, the Regulation should be amended to the effect that the deciding factors should be the journey time and the number of assembly operations, not whether the journey crosses a national border.

Stray animals: by 1 January 2018, Member States should introduce a registration requirement for dogs. The Commission shall submit by 31 July 2019 a report on the experience of the Member States with the registration and identification of dogs, with particular reference to stray animals.

Urgent measures: to tackle diseases that have a major impact on public health, agricultural production or animal welfare and health, the Commission must be empowered to adopt urgent measures. However, Members insist that both Parliament and Council must have proper scrutiny over the measures adopted and the possibility of repealing them if necessary.

Union reference laboratories: the Commission shall designate Union reference laboratories for illnesses for which, owing to their impact on health or the economy, this is necessary to achieve the objectives of the Regulation.

The objective of ensuring a high level of health for humans, animals, and plants is enshrined in the Treaties underpinning the EU. Over the years, the EU has built up a comprehensive body of law designed to prevent and manage risks to animal and plant health and the safety of the food chain at EU and national level. The law in these policy areas is enforced by means of a common set of rules on official controls to be carried out by the competent authorities in the EU Member States.

To date, overall, the legal framework which the EU has developed has proven to be effective in preventing and countering risks. However, the modern global market increasingly exposes the EU to new risks and constantly calls for innovation and competitiveness. This, and the experience gained with EU law in this area, point to the need to simplify and update available instruments and to further integrate the approach across the different areas. The Commission has conducted a revision of the current legal framework for animal health, plant health, plant reproductive material and official controls aimed mainly at increasing effectiveness, consistency and legal clarity in those areas.

This Communication presents the resulting four legislative proposals in the four areas of animal health, plant health, plant reproductive material and official controls (the ‘review package’) and explains, for each of them, the current context, the rationale behind the package and the main improvements introduced. The package also includes a fifth proposal establishing a multiannual programme for EU financing of actions aimed at ensuring a high level of health for humans, animals and plants along the agri-food chain and in related areas while allowing businesses to operate in an environment that favours competitiveness and job creation.

Context of animal health in the EU: currently, EU intervention is focused on preventing and controlling transmissible diseases that may have significant health and economic impacts. The impact of an animal disease outbreak can vary widely, but it usually poses a direct risk to animal and often public health, partly through food of animal origin. However, there can also be indirect negative effects (possibly economic or social), including the cost to farmers and related industries of dealing with disease and of business disruption, the cost to the public sector of eradicating and monitoring the disease, and changes in consumption and international trade patterns.

Current EU animal health legislative framework: the EU animal health legislative framework consists of around 50 basic directives and regulations, some of which were adopted in the early 1960s. Since then, a body of over 400 veterinary acts - most of them drawn up between 1988 and 1995 for a Community of only 12 Member States - has been built up. In the meantime, new challenges have emerged: new diseases have sprung up, while others (e.g. foot and mouth disease, bluetongue and avian flu) have recently reappeared, reminding us of the serious risks they pose.

Trading conditions have also changed radically, with the volume of trade in animal products increasing significantly both within the EU and worldwide.

Content of the proposed Animal Health Law (AHL): the purpose of the proposal is (i) to ensure a high level of public health and food safety; (ii) to support farming and the rural economy; to improve economic growth, cohesion and competitiveness; and (iii) to promote farming practices and animal welfare which minimise environmental impacts.

The main driving principles of the revision process in this area are simplification, modernisation and increased consistency across the EU’s animal health legislation.

The AHL lays down the foundations for a wide and comprehensive legislative framework for EU animal health policy. It clearly sets out the overarching principles and objectives necessary to further reduce animal disease while maintaining the EU’s economic competitiveness. Detailed provisions (such as specific disease control measures, identification and registration rules for certain species, and specific measures on intra-EU movement for particular species) are to be dealt with by means of delegated or implementing acts. Using these acts to introduce more specific rules or requirements would allow decision-makers the flexibility and speed needed to react to rapidly changing scenarios and veterinary emergencies.

The proposed enhancement of disease surveillance, disease notification and reporting networks would better support early detection and control of diseases (including emerging diseases such as those linked to climate change) and ensure greater convergence with international standards.

Simplification and clarification: a legislative framework that is simplified and easier to understand would be more user-friendly for authorities and operators and would ensure their actions are more consistent and objective-focused. This has the potential to reduce the administrative burden on them by cutting down the time taken to familiarise themselves with the legislation and by introducing scope for simplifying certain administrative requirements and making them more coherent. The new AHL will clarify the animal health responsibilities of operators, veterinarians and others, partly by requiring a basic level of knowledge for the first time.

New technologies: the AHL will allow more scope for using new technologies for animal health activities such as monitoring pathogens, electronic identification and registration of animals and electronic certificates. The use of new technologies and systems will tend to reduce the administrative burden on both veterinary authorities and operators in their work.

Increased flexibility through the use of a risk-based approach: criteria for listing animal diseases, categorised systematically and on a scientific and evidential basis, will be introduced so that the EU can better prioritise the use of its resources, giving less priority to diseases which pose less risk. The wider use of ‘compartmentalisation’ (i.e. where some farms are considered safe even during disease outbreaks), will allow a more risk-based approach to animal disease control and potentially fewer trade restrictions.

PURPOSE: to lay down rules for the prevention and control of animal diseases, which are transmissible to animals or to human beings.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: 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 main elements of the existing policy were drawn up largely between 1988 and 1995 when there were only twelve Member States.

New challenges, such as new diseases, have since emerged, and certain existing ones have reappeared. Trading conditions have also changed, with volumes of trade in animals and animal products increasing greatly, both within the EU and with third countries. There have, furthermore, been important scientific and technological developments, as well as important institutional changes within the EU.

A number of problems have been identified in regard to the existing legislation:

• with respect to the general policy approach:

- 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.

• with respect to the functioning of existing legislation:

- issues related to intra-Union trade in live animals.

For the above reasons, the European Commission is proposing a single, comprehensive animal health law to replace the complex animal health rules currently in place.

This proposal is part of a comprehensive package that also includes three other proposals to modernise the plant health, plant reproductive material and official controls acquis.

IMPACT ASSESSMENT: the proposal is accompanied by an impact assessment. An evaluation of the CAHP in the last decade led to the adoption of the new EU Animal Health Strategy 2007-2013 (AHS) "Prevention is better than cure".

The AHS, which was welcomed by Parliament, 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".

LEGAL BASIS: Articles 43, 114 and 168 of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the proposal seeks to establish a single, simplified, transparent and clear regulatory framework that sets out systematically the objectives, scope and principles of regulatory intervention in the field of animal health.

Aim of the proposal: the proposal aims to improve standards and to provide a common system to better detect and control disease and tackle health, food and feed safety risks in a coordinated way. It seeks to focus on long-term preventative measures and working together with relevant stakeholders.

Responsibilities of actors: 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 EU law. In particular, operators and animal professionals are now required to acquire a basic knowledge of animal health and related matters.

Notification and surveillance: the proposal 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. Better use will be made 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. Compartments, permitted only for Avian Influenza-related measures and in aquaculture at present, can now be used more widely. This allows more flexibility in disease control measures, introducing the possibility of continuing movements and trade under certain circumstances, considered from a risk-based perspective.

Disease Preparedness, Awareness and Control: the proposal continues to require Member States to draw up contingency plans for dealing with certain diseases, and to practise their implementation. It provides: (i) explicity for a regulatory framework for vaccination; (ii) rules for the use of antigen, vaccine and reagent banks; and (iii) rules on control measures to be taken in the case of suspicion of or confirmed disease outbreaks of certain diseases.

Requirements concerning Registration, Approval, Traceability and Movements: there would be distinct rules for terrestrial, aquatic, and other animals because of their different production methods and epidemiology. The proposal introduces the possibility for more animals to be registered and traced through electronic means, promoting simplicity and better regulation.

Imports and exports: the proposal sets out the standards and requirements for third countries in regard to animal imports, as well as requirements for exports. No practical changes from the existing legislation are envisaged.

Emergency Measures: these are considered a vital component of disease management and comprise the procedures to be followed in case of emergency, ensuring a rapid and consistent Union response. Only a few practical changes from the existing legislation are envisaged.

BUDGETARY IMPLICATIONS: 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.

DELEGATED ACTS: the proposal includes provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.