Draft Proposal for the EU Animal Health Law

SANCO/7221/2010/REV2 – Part 1

Commission staff working document:

Draft proposal for the EU Animal Health Law

This document does not necessarily represent the views of the Commission Services

Please note that this document has been established for information and consultation purposes only. It has not been adopted or in any way approved by the European Commission and should not be regarded as representative of the Commission Services either. The European Commission does not guarantee the accuracy of the information provided, nor does it accept responsibility for any use made thereof.

Please note that the work on ensuring coherence between this draft and other drafts that are part of the package to be submitted to Council and European Parliament in 2012 (Animal health, Plant health, Seeds and Propagating material and Official controls) is still ongoing. Consequently, further adaptation of the contents and the terminology of this draft might be necessary.

Draft Status: 21 December 2011

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of dd mm yyyy

………..

(Animal Health Law)

EN 10 EN

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on EU Animal Health Law

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee[1],

Having regard to the opinion of the Committee of the Regions[2],

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) [Initial capital…].

(2) [Initial capital…],

HAVE ADOPTED THIS REGULATION:

TITLE I
GENERAL RULES

CHAPTER I
Objective, subject matter, scope, definitions and general principles

Section 1
Objectives, subject matter, scope and definitions

Article 1
Subject matter

This Regulation lays down:

(a) general principles for the animal health law;

(b) principles for categorisation and prioritisation of Union measures concerning diseases;

(d) measures for the early detection and surveillance of diseases for animal health;

(e) measures to ensure traceability of animals and products;

(f) animal health rules on movements within and introduction into the Union;

(g) animal disease control and eradication measures.

Member States shall remain free to take additional measures concerning movement of animals within a Member State and in the domains referred to in (c), (d), (e) and (g), provided that such measures do not affect trade with other Member States or are in contradiction with this Regulation or other Union legislation, while taking into account the general principles of this Regulation.

Article 2
Scope

1. This Regulation shall apply to:

(a) animals;

(i) which are kept;

(ii) wild animals [when those animals may spread or be a reservoir of a disease which may be a threat to the health of kept animals , to the health of humans, to populations of wild animal or the environment;]

(b) germinal products;

(d) animal by-products and derived products not intended for human consumption, without prejudice of rules laid down in Regulation (EC) No 1069/2009.

2. This Regulation shall apply to zoonoses, without prejudice of rules laid down in Directive 2003/99/EC, Regulation (EC) No. 2160/2003, Regulation (EC) No999/2001 and Decision No 2119/98/EC;

3. This Regulation shall apply without prejudice to other Union legislation on the conservation of species or the introduction of invasive alien species;

4. Title II shall apply to:

(a) terrestrial animals;

(b) other animals that may transmit diseases affecting terrestrial animals;

5. Title III shall apply to:

(a) aquatic animals;

(b) other animals that may transmit diseases affecting aquatic animals;

6. Title IV shall apply to animals which are neither covered by Title II nor Title III.

Article 3
Objectives

The objective of this Regulation is to promote animal health, protect animal and human health from diseases affecting animals or transmitted by animals and products whilst:

(a) ensuring:

(i) the effective functioning of the internal market;

(ii) a sustainable agricultural and aquacultural production;

(iii) that negative environmental impacts are minimised;

(iv) that costs and benefits, and social and cultural aspects are considered and taken into account;

(b) taking into account the relationship between animal health and:

(i) human health and environment within the one health concept;

(ii) food and feed safety;

(iii) animal welfare;

(iv) food security.

Article 4
Definitions

1. For the purpose of this Regulation, the following definitions shall apply:

(1) ‘animal health law’ means the laws, regulations and administrative provisions governing animal health, whether at Union or national level; it covers any stage of production, processing and distribution of animals, germinal products, products of animal origin and animal by-products;

(2) 'Animals' means vertebrate and invertebrate animals;

(3) 'Kept animals' means animals kept by humans;

(4) 'Terrestrial animal' means terrestrial mammals, birds, bees and bumble bees;

(5) 'Aquatic animal' means fish, molluscs, crustaceans and amphibians living in an aquatic environment;

(6) 'Wild animal' means an animal not kept by humans;

(7) 'Ungulates' means artiodactyla listed in Annex X (based on list in Directive 2004/68)

(8) Equids: means animals belonging to the familiy equidae;

(9) 'Poultry' means all birds that are reared or kept in captivity for the production of meat or eggs for consumption, the production of other products, for restocking supplies of game birds or for the purposes of any breeding programme for the production of these categories of birds; (2005/94 adapted)‘other captive bird’ means any bird other than poultry that is kept in captivity for any reason other than those referred to in point ?? including those that are kept for shows, races, exhibitions, competitions, breeding or selling;

(10) 'Hatching eggs' means eggs for incubation, laid by poultry;

(11) 'concerned species' means animal species or group of species to which the measures for a concerned disease shall apply, taking into account their susceptibility to the concerned disease and epidemiological role for that disease;

(12) ‘non-commercial movement’ means any movement which does not involve or aim, directly or indirectly, at a financial gain or a transfer of ownership;

(13) ‘pet animal’ means an animal of the species listed in Annex I accompanying for the purposes of a non-commercial movement its owner, or a natural person acting on behalf of and in agreement with the owner, and which remains during such non-commercial movement under the responsibility of the owner or such person;

(14) 'owner' means a natural person that owns and possesses the pet animal;

(15) 'Products' means germinal products, products of animal origin, and animal by-products;

(16) "Products of animal origin" means:

(i) food of animal origin, including honey and blood;

(ii) live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption; and

(iii) other animals destined to be prepared with a view to being supplied live to the final consumer.

(17) 'Germinal products' means semen, [ova][oocytes], eggs, gametes, embrios intended for reproduction;

(18) 'Germinal product centre' means an establishment for the collection and storage of germinal products;

(19) 'Germinal product team' means a group of technicians or structure performing the collection, processing and storage of germinal products;

(20) 'Animal by-products' means entire bodies or parts of animals, products of animal origin or other products obtained from animals which are not intended for human consumption, including oocytes, embryos and semen;

(21) 'Risk' means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard;

(22) 'Hazard' means a disease in, or a condition of, an animal or product with the potential to cause an adverse health effect;

(23) 'Risk assessment' means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation;

(24) 'Risk management' [means the process of identifying, selecting and implementing measures that can be applied to reduce the level of risk.(OIE)] [means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options; (178/2002)];

(25) 'Diseases' means transmissible diseases, which include infectious or contagious animal diseases or infestations in animals, including zoonoses.

(26) 'Diseases of Union concern' means diseases listed in accordance with Article 14(5).

(27) 'Emerging disease' means a new infection resulting from the evolution or change of an existing pathogenic agent, a known infection spreading to a new geographic area or population, or a previously unrecognized pathogenic agent or disease diagnosed for the first time and which has a significant impact on animal or public health, other than diseases of Union concern;

(28) Establishment means any premise, any structure, or any environment, in which animals or germinal products are kept, [except veterinary practices or clinics];

(29) 'Operator' means the natural or legal person responsible for ensuring that the requirements of this Regulation are met within the establishment or means of transport under their control, including animal keeper;

(30) 'Transporter' means an operatortransporting animals on his own account, or for the account of a third party (Reg 1/2005);

(31) 'Dealer' means an operator who buys and sells animals commercially either directly or indirectly, who has a regular turnover of these animals and who within a certain defined period of purchasing animals depending on the species concerned resells them or relocates them from the first premises to other premises not within his ownership; (Dir 91/68)

(32) 'Confined establishment' means any permanent, geographically limited establishment, where the animals are:

(a) kept or bred for purposes other than food production,

(b) confined from the surrounding environment,

(33) 'Assembly centre' means establishment, including collection centres and markets, at which animals originating from different establishments are grouped together to form consignments of animals for movement;

(34) 'Quarantine' means the keeping of animals in isolation with no direct or indirect contact with other animals, to ensure that there is no [spread][transmission] of concerned diseases outside the establishment while the animals are undergoing observation for a specified length of time and, if appropriate, testing and treatment, under the control of the competent authority;

(35) 'Health status' means the aggregated disease status, including disease freedom, subject to surveillance and eradication programmes, of relevant diseases as appropriate to the species concerned in a given [establishment], Member States, third country or territory, zone, compartment;

(36) 'Epidemiological unit' means a group of animals with the same likelihood of exposure to a pathogen ;

(37) 'Zone' means a clearly defined part of a Member State, third country or territory containing an animal subpopulation with a distinct health status with respect to a specific disease subject to appropriate surveillance, control and biosecurity measures;.

(38) 'Compartment' means an animal subpopulation contained in one or more establishments under a common biosecurity management system with a distinct health status with respect to a specific disease or specific diseases subject to appropriate surveillance, control and biosecurity measures;.

(39) 'Disinfection' means the application, after thorough cleansing, of procedures intended to destroy the infectious or parasitic agents of animal diseases, including zoonoses; this applies to premises, vehicles and different objects which may have been directly or indirectly contaminated;.

(40) 'Disinfestation' means the application of procedures intended to eliminate arthropods which may cause diseases or are potential vectors of infectious agents of animal diseases, including zoonoses;.

(41) 'Outbreak' means the occurrence of one or more cases in an epidemiological unit(OIE);

(42) ['Restriction zone' means a defined zone around and including suspected or infected establishments, taking into account the epidemiological factors and results of investigations, where control measures to prevent the spread of the infection are applied. This zone includes protection and surveillance zone;]

(43) ['Containment zone' means a zone around an infected aquaculture establishment where disease control measures are applied with the purpose of preventing the spread of disease. This zone includes protection and surveillance zone;]

(44) Protection zone' (TO BE DEFINED);

(45) Surveillance zone' (TO BE DEFINED);

(46) ‘aquatic animal’ means the following species, at all its life stages, including eggs and sperm/gamets, when living in an aquatic environment:

(47) (i) fish belonging to the superclass Agnatha and to the classes Chondrichthyes and Osteichthyes;

(48) (ii) mollusc belonging to the Phylum Mollusca;

(49) (iii) crustacean belonging to the Subphylum Crustacea;

(50) (iv) amphibians belonging to the ......

(51) 'aquaculture' means the keeping of aquatic animals in an aquaculture establishment,

(52) 'aquaculture animal' (equivalent to kept terrestrial animals) means any aquatic animal kept in an aquaculture establishment, including any aquatic animal from the wild intended for an establishment,

(53) 'aquaculture establishment' means any premise, any structure, or any environment, in which aquatic animals are kept[, including relaying, purification centres, put and take fisheries,] [except veterinary practices or clinics], with the exception of establishments where wild aquatic animals harvested or caught for the purposes of human consumption are temporarily kept awaiting slaughter without being fed;

(54) 'approved aquaculture establishments' means aquaculture establishments requiring an approval in accordance with Article A+3(1)

(55) ‘disease control food establishment’ means any food business approved in accordance with Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin authorised in accordance with Article A+3(2) of this Regulation;

2. For the purpose of this Directive the definitions laid down in Regulation (EC) No882/2004 shall, as appropriate, also apply.

Section II
General principles of the animal health law

Article 5
Risk assessment and risk management

1. Risk management measures taken to achieve the objectives laid down in Article 3 shall: