The Council adopted its position at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health.
The regulation lays down provisions on the prevention and control of animal diseases which are transmissible among animals or to humans and amending and repealing certain acts in the area of animal health. It aims to:
- ensure high standards of animal and public health in the Union;
- implement the commitments and visions provided for in the Commission's Communication on animal health strategy including the "one health" principle;
- consolidate the legal framework for a common Union animal health policy through a single, simplified and flexible regulatory framework for animal health.
The main amendments made in the Council’s position are as follows:
Delegated and implementing powers: the proposed act will constitute a framework Regulation that will empower the Commission to determine a significant amount of its details by delegated and/or by implemented acts. While the Council did not change the principle of a framework Regulation, a large number of Articles were redrafted in order to better circumscribe the powers conferred on the Commission. Essential elements were introduced in the basic act in a number of cases.
Listing of diseases: disease-specific rules for the prevention and control of diseases provided for in the regulation shall apply to:
- the following five listed diseases: (i) foot and mouth disease; (ii) classical swine fever; (iii) African swine fever; (iv) highly pathogenic avian influenza; (v) African horse sickness; and
- the listed diseases set out in the list in Annex II.
The Council’s position strengthens the criteria in the basic act regarding the review of the listed diseases in Annex II and provides that the Commission will adopt the amendments necessary with reference to the criteria (by delegated act) at the latest 24 months before the date of application of the regulation.
Criteria for categorising the listed diseases: the categorisation of listed diseases, i.e. the application of disease prevention and control rules to each of those diseases, may be done by the Commission by implementing acts. In order to make the process of categorisation more predictable and transparent, the Council added more details to the proposed criteria, introduced new criteria and made those criteria binding. It also agreed that the criteria for the categorisation could only be amended by ordinary legislative procedure.
The categorisation process should be based on predefined criteria such as the profile of the listed disease in question, the level of its impact on animal and public health, animal welfare and the economy of the Union, the risk of its spreading and the availability of disease prevention and control measures in respect of that listed disease.
Emerging diseases: a disease other than a listed disease shall be considered to be an emerging disease provided it has the potential to meet the criteria for listing diseases and: (i) results from the evolution or change of an existing disease agent; (ii) is a known disease spreading to a new geographic area, species or population; (iii) is diagnosed for the first time in the Union; or (iv) is caused by an unrecognised or a previously unrecognised disease agent.
The Commission shall, by means of implementing acts, take the necessary measures regarding an emerging disease.
Transitional periods: to allow for more time to implement the legislation, the Council proposed an overall transitional period of 60 months. It also requested additional transitional measures, such as those obliging the Commission to adopt certain key delegated acts at least 24 months before the date of application of the Regulation and for other delegated and implementing acts to determine a period of at least six months between the adoption of the initial set of such acts and their application.
Transitional measures (recognition of acquired rights): the Council introduced new Articles providing the operators and Member States with the possibility of recognising rights as regards the approval or registration of existing operators and establishments, the approved
disease free statuses, and the special provisions for salmonella.
Registration obligation of certain operators conducting assembly operations: the Council position added provisions concerning the registration obligation of certain operators without establishments conducting transactions with animals that may have an impact on traceability of those animals.
Non-commercial movements of pet animals: Regulation (EU) 576/2013 sets out a simplified procedure for movements of pet animals when they are considered as non-commercial movements according to that Regulation. In order to ensure the stability of the rules of that Regulation, the Council agreed that, while it should be repealed by this Regulation, it should continue to apply for 10 years. The Council also included most of its elements in the basic act.