PURPOSE: to introduce a single piece of legislation to regulate animal health in the Union, based on the principle that "prevention is better than cure" in order to better detect and control diseases, as well as to tackle safety risks in a coordinated way.
LEGISLATIVE ACT: Regulation (EU) 2016/429 of the European Parliament and of the Council on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’)
CONTENT: the Regulation establishes provisions relating to the prevention and control of animal diseases that are transmissible to animals or to human beings. It aims to improve standards and to provide a common system to better detect and control diseases, as well as to tackle health, food and feed safety risks in a coordinated way.
Scope: the Regulation applies to: (a) kept and wild animals; (b) germinal products; (c) products of animal origin; (d) animal by-products and derived products; (e) facilities, means of transport, equipment and all other paths of infection and material involved or potentially involved in the spread of transmissible animal diseases.
Objectives: the new provisions relate to:
· the prioritisation and categorisation of diseases of Union concern and for the establishment of responsibilities for animal health: the provisions on prevention and control of the diseases will apply to: (a) the five following 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 (b) the listed diseases set out in the list in Annex II; (c) emerging diseases;
· the early detection, notification and reporting of diseases, surveillance, eradication programmes and disease–free status;
· disease awareness, preparedness and control;
· the registration and approval of establishments and transporters, movements and traceability of animals, germinal products and products of animal origin within the Union;
· the entry of animals, germinal products, and products of animal origin into the Union and the export of such consignments from the Union
· non–commercial movements of pet animals into a Member State from another Member State or from a third country or territory;
· the emergency measures to be taken in the event of a disease emergency situation.
The measures aim to ensure: (i) improved animal health to support sustainable agricultural and aquaculture production in the Union; (ii) the effective functioning of the internal market; (iii) a reduction in the adverse effects on animal health, public health and the environment of certain diseases and the measures taken to prevent and control diseases.
They must take into account:
· the relationship between animal health and: (i) public health; (ii) the environment, including biodiversity and valuable genetic resources, as well as the impact of climate change; (iii) food and feed safety; (iv) animal welfare, including the sparing of any avoidable pain, distress or suffering; (v) antimicrobial resistance; (vi) food security;
· the economic, social, cultural and environmental consequences arising from the application of disease control and prevention measures;
· relevant international standards.
Delegated and implementing powers: the act constitutes a framework Regulation, which will empower the Commission to determine a significant amount of the details by delegated and/or by implemented, acts. Implementing powers to lay down disease prevention and control measures for emerging diseases is conferred on the Commission. The latter may adopt delegated acts regarding amendments to the list of diseases in Annex II or regarding the restrictions on, prohibitions of or obligations to use certain veterinary medicinal products within the framework of the control of certain listed diseases.
Transitional period: the Regulation provides a general transitional transition period of 60 months (until 21 April 2021).
The requirements set out in the Regulation will not apply until the key delegated and implementing acts have been adopted by the Commission, allowing a period of 24 months from the adoption of the key acts until the date when they start to apply, thus permitting Member States and operators to duly adapt to the new rules. In addition, the Regulation provides for a period of at least 36 months for the Commission to elaborate the new rules.
ENTRY INTO FORCE: 20.4.2016. The Regulation is applicable from 21.4.2021.
DELEGATED ACTS: the Commission may adopt delegated acts in order to amend the non-essential elements of the Regulation. The power to adopt such acts is conferred on the Commission for a period of five years from 20th April 2016 (which may be tacitly extended for the same period). The European Parliament or Council may raise objections to a delegated act within two months of the date of notification (which may be extended by three months). If Parliament or Council raise objections, the delegated act may not enter into force.