EN
SANCO/7221/2010/REV2 – Part 2
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.
ENEN
Draft Status: 21 December 2011
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of dd mm yyyy
………..
(Animal Health Law)
TITLE II
TERRESTRIAL ANIMALS
Chapter 1
Registration, approval, record keeping and registers
Article X
Registration of establishments
1.With a view to registration in accordance with the procedure laid down in Article31(1)(a) of Regulation (EC) No 882/2004, operators keeping terrestrial animals shall:
(a)notify the competent authority of any establishment under their control;
(b)provide the competent authority with information on:
(i)name and address of the operator,
(ii)animal species kept in the establishment,
(iii)type of establishment.
2.Operators shall provide the competent authority with up-to-date information on any establishments referred to in Paragraph 1, in particular any significant change in activities and any closure of establishment.
3.By way of derogation from Paragraph 1 the competent authority may exempt from the registration obligation establishmentswhich represent a limited animal health risk, taking into account animal movements, and species and number of animals kept, type of establishment.
4.Whenever appropriate and relevant this registration may be combined with registration for other purposes.
5.The Commission shall be empowered to adopt implementing/delegated acts in accordance with Article XX concerning
(a)criteria for derogating from Paragraph 1, taking into account the concerns referred to in (3);
(b)further information that has to be provided by the operator.
6.The Commission may, by means of implementing acts, lay down:
(a)lists of type of establishments that do not need to be registered,
(b)(...)
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article XX.
Article X+1
Registration of transporters
1.With a view to registration in accordance with the procedure laid down in Article31(1)(a) of Regulation (EC) No 882/2004, transporters transporting kept terrestrial animals shall:
(a)inform the competent authority of their activity;
(b)provide the competent authority with information on:
(i)name and address of the transporter,
(ii)animal species transported,
(iii)type of transport
(iv)means of transport.
2.Transporters shall provide the competent authority with up-to-date information on their activity referred to in Paragraph 1, in particular any significant change in activities and any closure thereof.
3.By way of derogation from Paragraph 1, the competent authority may exempt transporters from the registration obligation which transport animals short distances,or of small quantities of animals or species and categories of animals which pose no animal or human health risk.
4.Whenever appropriate and relevant this registration may be combined with registration of the same transporter for other purposes.
5.The Commission shall be empowered to adopt delegated acts in accordance with Article XX concerning
(a)criteria for derogating from Paragraph 1, taking into account the concerns referred to in (3);
(b)further information that has to be provided by the transporter.
6.The Commission may, by means of implementing acts, lay down:
(a)lists of categories of transporters that do not need to be registered,
(b)(...)
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article XX.
Article X+2
Approval of establishments
1.Operators of the following categories of animal establishments shall ensure that their establishments are approved in accordance with the procedure laid down in Article31(2) of Regulation (EC) No 882/2004 by the competent authority:
(a)assembly centres for ungulates and equids,
(b)dealers, [traders] for ungulates and equids,
(c)germinal product centres and teams for bovine, porcine, ovine, caprine and equine animals,
(d)establishments for hatching eggs, breeding poultry and productive poultry,
(e)any other animal establishment which due to type of terrestrial animals kept or the frequency, volume, origin or destination of the terrestrial animals moved into and from the establishment pose [an extraordinary][a significant][???] animal health risk.
2.Establishments wanting to obtain status as confined establishment shall also be approved in accordance with Paragraph 1.
3.The approval referred to in paragraph 1 shall specify if the establishment is approved for:
(a)a specific purpose;
(b)specific terrestrial animal species or category of animals;
(c)(…..)
4.An approval as provided for in Paragraph 1 shall only be granted if the establishment:
(a) fulfils the relevant requirements of Articles 16 (veterinary vist), 10 (biosecurity measures)and X+3 (recordkeeping);
(b) has a system in place which enables the operator to demonstrate to the competent authority that those relevant requirements are being fulfilled; and
(c) remains under the supervision of the competent authority.
5.Approval shall not be granted if the activity in question were to lead to an unacceptable risk of spreading diseases to other terrestrial establishments or animals.
However, before a decision to refuse approval is taken, consideration shall be given to risk-mitigation measures.
6.The Commission shall be empowered to adopt implementing/delegated acts in accordance with Article XX:
(a)Defining categories of establishments [amending the list referred to in paragraph 1], which require an approval according to Paragraph 1(e);
(b)laying down requirements for the establishments that need to be authorised in accordance with Paragraph 1 taking into account the animal health risk posed by the type of establishment concerning:
(i)infrastructure, equipment and other biosecurity requirements for establishments referred to in Paragraph 1;
(ii)record keeping obligations;
(iii)the necessary control by the competent authority;
(iv)animal health requirements;
(.....)
7.The Commission shall be empowered to adopt delegated acts in accordance with Article XX derogating from the obligation of approval, when the volume of movements, risks involved, other risk mitigating measures in place justify such an exemption.
8.The Commission may, by means of implementing acts, lay down provisions on:
(a)the types, formats of record keeping referred to in Paragraph 6(b)(ii) and availability to the competent authority and the public,
(b)the information to be submitted to the Competent Authority to document that the approval requirements are fulfilled,
(c)(.....)
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article XX. Pending the adoption by the Commission of those implementing acts, national rules shall continue to apply.
Article X+3
Record keeping
1.Operators shall keep records of their establishment containing at least the following information:
(a)animals and germinal products kept on the establishment;
(b)all movement of animals into and out of the establishment, stating as appropriate their origin or destination, and the date of the movements;
(c)all document accompanying terrestrial animals and germinal products arriving at the establishment;
(d)disease problems;
(e)biosecurity measures, treatments, test results and other relevant information as appropriate for the category and species of animals kept and the type of production,
(f)(….).
2.Transporters shall keep records containing at least information on:
(a)establishments visited,
(b)species and number or volume of animals and germinal product carried,
(c)cleaning and disinfection,
(d)(…)
3.[By way of derogation from Paragraph 1, records shall be optional for operators and transporters:
(a)have direct access to the establishment and transporters register referred to in Article X+3; and
(b)enter up-to-date information directly into that register.]
4.The Commission shall be empowered to adopt delegated acts in accordance with Article XX concerning:
(a)derogating from Paragraph 1 for certain categories of animals or establishments and transporters;
(b)further information to be recorded;
(c)how long the records shall be kept;
(d)(...)
5.When establishing rules referred to in Paragraph 4 the following shall be taken into account:
(a)the animal species concerned,
(b)the animal health risk posted by the animal species in question,
(c)the ways in which the animals are kept,
(d)typical movement patterns,
(e)(.....)????
6.[The Commission may, by means of implementing acts, lay down provisions on:
(a)format of records;
(b)(..)]
Article X+4
Establishment and transporter register[l1]
1.Competent authority shall establish, keep up-to-date a register of all establishments and transporters registered and approved in accordance with Article X+1, X+2, X-3.
2.The Commission shall be empowered to adopt delegated acts in accordance with Article XX concerning:
(a)information to be included in the register;
(b)(...)
3.The Commission may, by means of implementing acts, lay down provisions on:
(a)format of the register;
(b)(..)
Article X+5
Exemptions
This Chapter does not apply to pet animals.
Chapter II
Identification and registration of kept terrestrial animals
Article Y
General principles
1.Operators shall ensure that kept terrestrial animals are identified and registered, when appropriate for the type of species and the animal health risk posed by that species.
2.Identification and registration shall comprise of the following elements:
(a)establishment registration as referred to in Chapter I, as appropriate;
(b)identification of the animals and germinal products;
(c)recording of terrestrial animals and germinal products and animal movements.
3.The identification and registration systems shall ensure efficient traceability of animals kept on establishments, moved within Member States and contribute to the traceability of movements between Member States and into the Union from third countries as appropriate, for disease control purposes whilst ensuring that the traceability systems are suitable enough to, when relevant, serve other objectives.
4.The Commission shall be empowered to adopt delegated acts in accordance with Article XX concerning:
(a)obligation to identify,
(b)identification systems,
(c)time limits for identification, registration and notification,
(d)movement documents to accompany animals,
(e)computerised database,
(f)other provisions to ensure traceability and operation of the system.
5.When establishing these rules the following shall be taken into account:
(a)species or category of animals kept,
(b)the animal health risk posed by the animal in question,
(c)the ways in which the animals are kept or type of production,
(d)movement patterns,
(e)specific keeping conditions
6.The Commission shall be empowered to adopt delegated acts in accordance with Article XX derogating from the obligations laid down in Paragraph 2 taking into account the provisions laid down in Paragraph 5.
Chapter III
Requirements for movements of terrestrial animals within the Union
Section 1
General requirements
Article Z
General principle for movement of kept terrestrial animals
1.The operator shall take appropriate preventive measures to ensure that the movement of kept terrestrial animals does not jeopardise the health status at the place of destination with regard to the diseases of the Union concern[and emerging diseases].
2.Kept terrestrial animals shall only be moved provided they:
(a)when required in accordance with Chapter I, come from an establishment which is registered and approved;
(b)when required in accordance with Section 2 of Chapter II, are identified, registered and accompanied by a movement document or equivalent electronic means of communication.
Article Z+1
Disease prevention requirements in relation to transport
1.The operator and transporter shall take the [appropriate][necessary] preventive measures to ensure that the health status of the kept terrestrial animals is not altered during transport and to prevent spreading of diseases to animals at places of transit, assembly and destination.
2.The Commission shall be empowered to adopt implementing/delegated acts in accordance with Article XX concerning cleaning, disinfection, equipment and means of transport, labelling, sealing and other preventive measures during transport.
Article Z+2
General principles for movement of kept terrestrial animals between Member States
1.Kept terrestrial animals shall only be moved to another Member State provided they:
(a)come from an establishment:
(i)where there are no abnormal mortalities or other disease symptoms with an undetermined cause;
(ii)which is not subject to movement restrictions affecting the concerned species in accordance with the provisions laid down in Chapter VII (ERADICATION AND CONTROL CHAPTER);
(iii)which is not situated in a zonewhich is subject to movement restrictions affecting the concerned species in accordance with provisions laid down in Chapter VII (ERADICATION AND CONTROL CHAPTER);
(b)have not been in contact with kept terrestrial animals subject to movement restrictions or kept terrestrial animals of a lower health status during a sufficient period of time prior to dispatch to ensure the those animals have not transmitted any diseases of Union concern, taking into consideration the incubation period and routes of transmission of the relevant diseases, the concerned species, and type of production and other epidemiological factors;
(c)comply with the relevant movement requirements laid down in Sections 2 and 3.
2.Kept terrestrial animals shall after leaving their establishment of origin be consigned directly to the establishment of destination, unless derogations are provided for under this Regulation.
3.Kept terrestrial animals intended for export to a third country and transiting on their route through the territory of another Member States shall comply shall comply with the requirements of this Chapter, as relevant for disease and animal species concerned.
4.Kept terrestrial animals shall not be moved to another Member State, unless the Member State of destination gives its explicit permission, if they:
(a)are intended to be slaughtered for disease eradication purposesas a part of an eradication programme referred to in Article Dis + 1; or
(b)are not authorised to move within the zone or Member State of origin due to public or animal health and [biosecurity] restrictions.
5.The Commission shall be empowered to adopt delegated acts in accordance with Article:
(a)derogating from Paragraph 2 in cases where a non-direct movement will not jeopardise the animal health status of the place of destination and along the route of transport and the conditions for such derogation;
(b)laying down detailed requirements for movements prior to export as referred to in Paragraph 3.
Article Z+3
Disease prevention requirements for assembly operations
1.The operator must ensure that any assembly operation of kept ungulates and equidsintended for another Member State takes place in an approved assembly centre, [or approved dealer's premises] fulfilling the biosecurity and other obligations as referred to in Articles 11, X+2 and X+3.
2.Kept terrestrial animals may only be subject to one assembly operation prior to the dispatch to another Member State.
3.Kept terrestrial animals shall not stay longer in an assembly centre than necessary, taking into account the species, the category and the age of the animals.
4. The Commission shall be empowered to adopt delegated acts derogating form the provisions of Paragraph 2 in accordance with Article XX taking into consideration alternative risk mitigating measures in place.
5.The Commission shall, for the uniform application of Paragraphs 2 and 3 by means of implementing acts, lay down detailed rules for the movement of animals referred to in Paragraph 1 through assembly centres on their route and the times spent in those centres.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article XX. [Pending the adoption by the Commission of those implementing acts, national rules shall continue to apply.]
Article Z+4
Animal health certification for movements to another Member State
1.Operators shall ensure that the following species and categories of kept terrestrial animals which are moved to another Member State are accompanied by an animal health certificate issued by the competent authority:
(a)ungulates;
(b)equids, [except registered horses;]
(c)poultry and hatching eggs;
(d)animals intended for a confined establishment.
2.The operator must provide the competent authority with all information necessary to complete the animal health certificate.
3.The animal health certificate shall at least contain:
(a)information on the origin, the destination and when relevant places of transit or rest….,
(b)description of the kept terrestrial animals and the quantity, identification and registration when required by Chapter 2,
(c)information needed to demonstrate that the kept terrestrial animals of the consignment meet the movementconditions laid down in this chapter.
4.The animal health certificates must accompany the kept terrestrial animals from their place of origin to their place of destination.
5.The animal health certificate may include details required under other provisions of Union legislation.
6.The Commission shall be empowered to adopt delegated acts in accordance with Article…
(a)derogating from the animal health certificate requirements laid down in Paragraph 1, and the conditions for such derogation, for movements which do not pose significant risk of spreading of diseases due to:
(i)the nature [or species?] of the kept terrestrial animals;
(ii)methods of keeping and production systems;
(iii)the intended final use of the animals;
(iv)the destination of the animals;
(v)special or alternative risk mitigating measures [by the Competent Authorities] in place;
(vi)special controlled systemestablished by the competent authority in a certain defined area in respect to the health status of the concerned species;
(b)requiring that an animal health certificate is accompanying kept terrestrial animals other than those referred to in Paragraph 1 when necessary to ensure that the animal health requirements of this Regulation are complied with for the concerned species.,
(c)laying down specific certification requirements for assembly operations and other particular movement patterns.
7.The Commission may, by means of implementing acts, lay down provisions on:
(a)model animal health certificates;
(b)procedures for certification and validity of animal health certificates (LINK TO 882);
(c) special and alternative risk mitigating measures referred to in Paragraph 6 (a) (v);
(d)specific provisions for the implementation of the system referred to in Paragraph 6 (a) (vi).