Ms Hazel Sheridan:

I will read a short statement to deal with the background and core components of the regulation and the timescale envisaged.

The text in relation to the proposed animal health regulation was first presented to the European Council in May of this year. The background and aims of the proposal are described in the earlier information note for the committee. The proposed animal health regulation, when it comes into force, will be the main legislative instrument implementing the goals and objectives of the EU animal health strategy. The regulation will not be implemented for three years after the date of its adoption. It is envisaged that it will take two years to work its way through the various committees. We are now in year one of that process. The period of three years after the regulation is published is to allow the Commission time to draw up and agree the many delegated and implementing Acts mentioned in the regulation.

The regulation seeks to consolidate and simplify existing rules by creating a single regulatory framework that will replace more than 40 existing directives and regulations. As well as taking account of existing rules, the regulation seeks to provide for the future and for differences between member states by laying down a set of general principles for the prevention and control of animal diseases. These general principles will be fleshed out in a series of delegated and implementing Acts. In the words of the European Commission, the regulation represents evolution, not revolution.

The regulation will apply not just to production animals; it will also apply to fish, wild animals and pet animals. The regulation contains increased emphasis on prevention rather than cure, which is consistent with the overall vision of the EU animal health strategy. Prevention measures focus on increased bio-security at farms during transport and at the borders of the European Union; enhanced surveillance; requirements for disease notification and reporting; and a clearer policy on the use of vaccines and other veterinary medicinal products for disease control and prevention.

The regulation focuses on preparedness, laying down requirements in relation to contingency planning, simulation exercises and prescribed disease-eradication programmes. The regulation contains a suite of emergency measures that can be implemented at member state or EU level when the need arises. It provides for an enhanced response to emerging diseases, beginning with surveillance and contingency planning, and disease control measures in the event of the outbreak of an emerging disease.

The regulation uses a risk-based approach to deal with animal diseases. At the centre of the regulation will be a list of diseases of EU significance. The list is currently being drawn up by the Commission as part of a joint exercise with the OIE, the international body for animal health in the context of the WTO arrangement. This list will be contained in an implementing Act. The regulation provides for a hierarchy of control measures and each disease will be attached to one or more sets of control measures, depending on its significance within the Union.

At the core of the regulation is the principle that primary responsibility for animal health lies with animal owners and industry. In that context, the regulation lays down responsibilities not just for competent authorities but also for operators, animal professionals, pet keepers, veterinarians and aquatic animal health professionals.

The regulation is designed to facilitate trade by providing for enhanced convergence with international standards, principally those laid down in the OIE code. This convergence extends to terrestrial animals the use of compartments, a concept that has been used in the fish and poultry sectors to facilitate the continuation of trade during outbreaks of an exotic disease, most recently avian influenza.

The regulation is part of a package and, as such, it is very closely allied to the proposed official controls regulation in that the latter will require the competent authority - in this case, staff - to carry out official controls on all operators to ensure compliance with the provisions of the animal health regulation. In addition, the official controls regulation will regulate activities that fall under the definition of other official activities carried out by the Department, as provided for in the animal health regulation.

The first reading of the draft animal health regulation began with a meeting held in June under the Irish Presidency and has continued with two further meetings, one held in July and one held in September.

Three further meetings are planned for this year, in October, November and December, by which time it is expected the first read-through of the legislation will have been completed. Once the first read-through has been completed, it is expected the Presidency and the Council will produce a revised text incorporating the comments of member states.

A number of member states have expressed concern about the number of delegated and implementing Acts mentioned in the regulation, commenting that it is very difficult to assess the implications of the legislation without knowing what will be included in the delegated and implementing Acts. In response, the Commission has suggested that drafting the delegated and implementing Acts ahead of agreeing the general principles is to put the cart before the horse. However, it has agreed to produce a draft of the implementing Acts that will list the diseases considered to be of EU significance and decide what control measures will apply to each disease. It intends to present this document to the chief veterinary officers before year end. In the context of the delegated and implementing Acts, Ireland has commented on the need to provide for flexibility at member state level with regard to certain provisions.

In summary, we are in the very early stages of the process. The regulation will have to be adopted by co-decision procedure and, as I said, the timeframe for adoption is two years, followed by three further years of delay to give the Commission time to draw up the various implementing and delegated regulations.