# Official Journal C 203E/2010

| | ISSN 1725-2423
  doi:10.3000/17252423.CE2010.203.eng |
| --- | --- |
| Official Journal
  of the European Union | C 203E |
| | |
| English edition | Information and Notices | Volume 5327 July 2010 |

ISSN 1725-2423

doi:10.3000/17252423.CE2010.203.eng

Official Journal

of the European Union

C 203E

English edition

Information and Notices

Volume 5327 July 2010

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| Notice No | Contents | page |
| --- | --- | --- |
| | III   Preparatory acts |
| | Council |
| 2010/C 203E/01 | Position (EU) No 11/2010 of the Council at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transportAdopted by the Council on 10 May 2010 (
  1
  ) | 1 |
| 2010/C 203E/02 | Position (EU) No 12/2010 of the Council at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the protection of animals used for scientific purposesAdopted by the Council on 3 June 2010 (
  1
  ) | 19 |

Notice No

Contents

page

III   Preparatory acts

Council

2010/C 203E/01

Position (EU) No 11/2010 of the Council at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transportAdopted by the Council on 10 May 2010 (
  1
  )

1

1

2010/C 203E/02

Position (EU) No 12/2010 of the Council at first reading with a view to the adoption of a directive of the European Parliament and of the Council on the protection of animals used for scientific purposesAdopted by the Council on 3 June 2010 (
  1
  )

1

19

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | |
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EN

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III Preparatory acts

Council

| 27.7.2010 | EN | Official Journal of the European Union | CE 203/1 |
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27.7.2010

EN

Official Journal of the European Union

CE 203/1

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POSITION (EU) No 11/2010 OF THE COUNCIL AT FIRST READING

with a view to the adoption of a directive of the European Parliament and of the Council on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport

Adopted by the Council on 10 May 2010

(Text with EEA relevance)

(2010/C 203 E/01)

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 91 thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

Having consulted the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

| (1) | The increase in the volume of road transport in the Union associated with the growth of the European economy and mobility requirements of citizens is the primary cause of increasing congestion of road infrastructure and rising energy consumption, as well as a source of environmental and social problems. |
| --- | --- |

(1)

The increase in the volume of road transport in the Union associated with the growth of the European economy and mobility requirements of citizens is the primary cause of increasing congestion of road infrastructure and rising energy consumption, as well as a source of environmental and social problems.

| (2) | The response to those major challenges cannot be limited to traditional measures, inter alia the expansion of the existing road transport infrastructure. Innovation will have a major role to play in finding appropriate solutions for the Union. |
| --- | --- |

(2)

The response to those major challenges cannot be limited to traditional measures, inter alia the expansion of the existing road transport infrastructure. Innovation will have a major role to play in finding appropriate solutions for the Union.

| (3) | Intelligent Transport Systems (ITS) are advanced applications which without embodying intelligence as such aim to provide innovative services relating to different modes of transport and traffic management and enable various users to be better informed and make safer, more coordinated and ‘smarter’ use of transport networks. |
| --- | --- |

(3)

Intelligent Transport Systems (ITS) are advanced applications which without embodying intelligence as such aim to provide innovative services relating to different modes of transport and traffic management and enable various users to be better informed and make safer, more coordinated and ‘smarter’ use of transport networks.

| (4) | ITS integrate telecommunications, electronics and information technologies with transport engineering in order to plan, design, operate, maintain and manage transport systems. The application of information and communication technologies to the road transport sector and its interfaces with other modes of transport will make a significant contribution to improving environmental performance, efficiency, including energy efficiency, safety and security of road transport, including the transport of dangerous goods, public security and passenger and freight mobility, whilst at the same time ensuring the functioning of the internal market as well as increased levels of competitiveness and employment. However, ITS applications should be without prejudice to matters concerning national security or which are necessary in the interest of defence. |
| --- | --- |

(4)

ITS integrate telecommunications, electronics and information technologies with transport engineering in order to plan, design, operate, maintain and manage transport systems. The application of information and communication technologies to the road transport sector and its interfaces with other modes of transport will make a significant contribution to improving environmental performance, efficiency, including energy efficiency, safety and security of road transport, including the transport of dangerous goods, public security and passenger and freight mobility, whilst at the same time ensuring the functioning of the internal market as well as increased levels of competitiveness and employment. However, ITS applications should be without prejudice to matters concerning national security or which are necessary in the interest of defence.

| (5) | Advances in the field of the application of information and communication technologies to other modes of transport should now be reflected in developments in the road transport sector, in particular with a view to ensuring higher levels of integration between road transport and other modes of transport. |
| --- | --- |

(5)

Advances in the field of the application of information and communication technologies to other modes of transport should now be reflected in developments in the road transport sector, in particular with a view to ensuring higher levels of integration between road transport and other modes of transport.

| (6) | In some Member States national applications of these technologies are already being deployed in the road transport sector. However, such deployment remains fragmented and uncoordinated and cannot provide geographical continuity of ITS services throughout the Union and at its external borders. |
| --- | --- |

(6)

In some Member States national applications of these technologies are already being deployed in the road transport sector. However, such deployment remains fragmented and uncoordinated and cannot provide geographical continuity of ITS services throughout the Union and at its external borders.

| (7) | To ensure a coordinated and effective deployment of ITS within the Union as a whole, specifications, including, where appropriate, standards, defining further detailed provisions and procedures should be introduced. Before adopting any specifications, the Commission should assess their compliance with certain defined principles set out in Annex II. Priority should be given in the first instance to the four main areas of ITS development and deployment. Within those four areas, priority actions should be established for the development and use of specifications and standards. During further implementation of ITS the existing ITS infrastructure deployed by a particular Member State should be taken into account in terms of technological progress and financial efforts made. |
| --- | --- |

(7)

To ensure a coordinated and effective deployment of ITS within the Union as a whole, specifications, including, where appropriate, standards, defining further detailed provisions and procedures should be introduced. Before adopting any specifications, the Commission should assess their compliance with certain defined principles set out in Annex II. Priority should be given in the first instance to the four main areas of ITS development and deployment. Within those four areas, priority actions should be established for the development and use of specifications and standards. During further implementation of ITS the existing ITS infrastructure deployed by a particular Member State should be taken into account in terms of technological progress and financial efforts made.

| (8) | When a legislative act is adopted as referred to in the second subparagraph of Article 6(2) of this Directive, the second sentence of Article 5(1) should be amended accordingly. |
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(8)

When a legislative act is adopted as referred to in the second subparagraph of Article 6(2) of this Directive, the second sentence of Article 5(1) should be amended accordingly.

| (9) | The specifications should, inter alia take into account and build upon the experience and results already obtained in the field of ITS, notably in the context of the eSafety initiative, launched by the Commission in April 2002. The eSafety Forum was established by the Commission under that initiative to promote and further implement recommendations to support the development, deployment and use of eSafety systems. |
| --- | --- |

(9)

The specifications should, inter alia take into account and build upon the experience and results already obtained in the field of ITS, notably in the context of the eSafety initiative, launched by the Commission in April 2002. The eSafety Forum was established by the Commission under that initiative to promote and further implement recommendations to support the development, deployment and use of eSafety systems.

| (10) | Vehicles which are operated mainly for their historical interest and were originally registered and/or type-approved and/or put into service before the entry into force of this Directive and of its implementing measures should not be affected by the rules and procedures laid down in this Directive. |
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(10)

Vehicles which are operated mainly for their historical interest and were originally registered and/or type-approved and/or put into service before the entry into force of this Directive and of its implementing measures should not be affected by the rules and procedures laid down in this Directive.

| (11) | ITS should build on interoperable systems which are based on open and public standards and available on a non-discriminatory basis to all application and service suppliers and users. |
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(11)

ITS should build on interoperable systems which are based on open and public standards and available on a non-discriminatory basis to all application and service suppliers and users.

| (12) | The deployment and use of ITS applications and services will entail the processing of personal data. Such processing should be carried out in accordance with Union law, as set out, in particular, in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) and in Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (4). Inter alia, the principles of purpose limitation and data minimisation should be applied to ITS applications. |
| --- | --- |

(12)

The deployment and use of ITS applications and services will entail the processing of personal data. Such processing should be carried out in accordance with Union law, as set out, in particular, in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (3) and in Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (4). Inter alia, the principles of purpose limitation and data minimisation should be applied to ITS applications.

| (13) | Anonymisation as one of the principles of enhancing individuals' privacy should be encouraged. As far as data protection and privacy related issues in the field of ITS applications and services deployment are concerned, the Commission should, as appropriate, further consult the European Data Protection Supervisor and request an opinion of the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of Directive 95/46/EC. |
| --- | --- |

(13)

Anonymisation as one of the principles of enhancing individuals' privacy should be encouraged. As far as data protection and privacy related issues in the field of ITS applications and services deployment are concerned, the Commission should, as appropriate, further consult the European Data Protection Supervisor and request an opinion of the Working Party on the Protection of Individuals with regard to the Processing of Personal Data established by Article 29 of Directive 95/46/EC.

| (14) | The deployment and use of ITS applications and services, and notably traffic and travel information services, will entail the processing and use of road, traffic and travel data forming part of documents held by public sector bodies of the Member States. Such processing and use should be carried out in accordance with Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (5). |
| --- | --- |

(14)

The deployment and use of ITS applications and services, and notably traffic and travel information services, will entail the processing and use of road, traffic and travel data forming part of documents held by public sector bodies of the Member States. Such processing and use should be carried out in accordance with Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (5).

| (15) | In appropriate cases, the specifications should include detailed provisions laying down the procedure governing assessment of conformity or suitability for use of constituents. Those provisions should be based on Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (6), in particular concerning the modules for the various phases of the conformity assessment procedures. Directive 2007/46/EC (7) already establishes a framework for the type approval of motor vehicles and their parts or related equipment, and Directive 2002/24/EC (8) and Directive 2003/37/EC (9) lie down rules on the type approval of two or three-wheel motor vehicles, and agricultural or forestry tractors and their parts or related equipment. Therefore, it would be a duplication of work to provide for conformity assessment of equipment and applications falling within the scope of those Directives. At the same time, although those Directives apply to ITS-related equipment installed in vehicles, they do not apply to external road infrastructure ITS equipment and software. In such cases, the specifications could provide for conformity assessment procedures. Such procedures should be limited to what would be necessary in each separate case. |
| --- | --- |

(15)

In appropriate cases, the specifications should include detailed provisions laying down the procedure governing assessment of conformity or suitability for use of constituents. Those provisions should be based on Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products (6), in particular concerning the modules for the various phases of the conformity assessment procedures. Directive 2007/46/EC (7) already establishes a framework for the type approval of motor vehicles and their parts or related equipment, and Directive 2002/24/EC (8) and Directive 2003/37/EC (9) lie down rules on the type approval of two or three-wheel motor vehicles, and agricultural or forestry tractors and their parts or related equipment. Therefore, it would be a duplication of work to provide for conformity assessment of equipment and applications falling within the scope of those Directives. At the same time, although those Directives apply to ITS-related equipment installed in vehicles, they do not apply to external road infrastructure ITS equipment and software. In such cases, the specifications could provide for conformity assessment procedures. Such procedures should be limited to what would be necessary in each separate case.

| (16) | For ITS applications and services for which accurate and guaranteed timing and positioning services are required, satellite-based infrastructures or any technology providing an equivalent level of precisions should be used, such as those provided for in Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations (10) and Regulation (EC) No 683/2008 of the European Parliament and of the Council of 9 July 2008 on the further implementation of the European satellite navigation programmes (EGNOS and Galileo) (11). |
| --- | --- |

(16)

For ITS applications and services for which accurate and guaranteed timing and positioning services are required, satellite-based infrastructures or any technology providing an equivalent level of precisions should be used, such as those provided for in Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations (10) and Regulation (EC) No 683/2008 of the European Parliament and of the Council of 9 July 2008 on the further implementation of the European satellite navigation programmes (EGNOS and Galileo) (11).

| (17) | Innovative technologies such as Radio Frequency Identification Devices (RFID) or EGNOS/Galileo should be used for the realisation of ITS applications, notably for the tracking and tracing of freight along its journey and across modes of transport. |
| --- | --- |

(17)

Innovative technologies such as Radio Frequency Identification Devices (RFID) or EGNOS/Galileo should be used for the realisation of ITS applications, notably for the tracking and tracing of freight along its journey and across modes of transport.

| (18) | Major stakeholders such as ITS service providers, associations of ITS users, transport and facilities operators, representatives of the manufacturing industry, social partners, professional associations and local authorities should have the possibility to advise the Commission on the commercial and technical aspects of the deployment of ITS within the Union. For this purpose the Commission, ensuring close cooperation with stakeholders and Member States, should set up an ITS advisory group. The work of the advisory group should be carried out in a transparent manner and the result should be made available to the Committee established by this Directive. |
| --- | --- |

(18)

Major stakeholders such as ITS service providers, associations of ITS users, transport and facilities operators, representatives of the manufacturing industry, social partners, professional associations and local authorities should have the possibility to advise the Commission on the commercial and technical aspects of the deployment of ITS within the Union. For this purpose the Commission, ensuring close cooperation with stakeholders and Member States, should set up an ITS advisory group. The work of the advisory group should be carried out in a transparent manner and the result should be made available to the Committee established by this Directive.

| (19) | Uniform conditions of implementation should be ensured for the adoption of guidelines and non-binding measures to facilitate Member's States cooperation in respect of priority areas on ITS as well as in respect of guidelines for reporting by the Member States and of a working programme. |
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(19)

Uniform conditions of implementation should be ensured for the adoption of guidelines and non-binding measures to facilitate Member's States cooperation in respect of priority areas on ITS as well as in respect of guidelines for reporting by the Member States and of a working programme.

| (20) | According to Article 291 of the Treaty on the Functioning of the European Union (TFEU), rules and general principles concerning mechanisms for the control by Member States of the Commission's exercise of implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable. |
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(20)

According to Article 291 of the Treaty on the Functioning of the European Union (TFEU), rules and general principles concerning mechanisms for the control by Member States of the Commission's exercise of implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.

| (21) | The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the TFEU in respect of the adoption of specifications. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. |
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(21)

The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the TFEU in respect of the adoption of specifications. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.

| (22) | In order to guarantee a coordinated approach, the Commission should ensure coherence between the activities of the Committee established by this Directive and those of the Committee established by Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004 on the interoperability of electronic road toll systems in the Community (13), the Committee established by Council Regulation (EEC) No 3821/85 on recording equipment in road transport (14), the Committee established by Directive 2007/46/EC and the Committee established by Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (15). |
| --- | --- |

(22)

In order to guarantee a coordinated approach, the Commission should ensure coherence between the activities of the Committee established by this Directive and those of the Committee established by Directive 2004/52/EC of the European Parliament and of the Council of 29 April 2004 on the interoperability of electronic road toll systems in the Community (13), the Committee established by Council Regulation (EEC) No 3821/85 on recording equipment in road transport (14), the Committee established by Directive 2007/46/EC and the Committee established by Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (15).

| (23) | Since the objective of this Directive, namely to ensure the coordinated and coherent deployment of interoperable Intelligent Transport Systems throughout the Union cannot be sufficiently achieved by the Member States and/or the private sector and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective. |
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(23)

Since the objective of this Directive, namely to ensure the coordinated and coherent deployment of interoperable Intelligent Transport Systems throughout the Union cannot be sufficiently achieved by the Member States and/or the private sector and can therefore, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

| (24) | In accordance with point 34 of the Interinstitutional Agreement on better law-making, Member States are encouraged to draw up, for themselves and in the interest of the Union, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public, |
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(24)

In accordance with point 34 of the Interinstitutional Agreement on better law-making, Member States are encouraged to draw up, for themselves and in the interest of the Union, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Subject matter and scope

1.   This Directive establishes a framework in support of the coordinated and coherent deployment and use of Intelligent Transport Systems (ITS) within the Union, in particular across the borders between the Member States, and sets out the general conditions necessary for that purpose.

2.   This Directive provides for the development of specifications for actions within the priority areas referred to in Article 2, as well as for the development, where appropriate, of necessary standards.

3.   This Directive shall apply to ITS applications and services in the field of road transport and to their interfaces with other modes of transport without prejudice to matters concerning national security or necessary in the interest of defence.

Article 2

Priority areas

1.   For the purpose of this Directive the following shall constitute priority areas for the development and use of specifications and standards:

| — | I. | Optimal use of road, traffic and travel data; |
| --- | --- | --- |
| — | II. | Continuity of traffic and freight management ITS services; |
| — | III. | ITS road safety and security applications; |
| — | IV. | Linking the vehicle with the transport infrastructure. |

—

I.

Optimal use of road, traffic and travel data;

—

II.

Continuity of traffic and freight management ITS services;

—

III.

ITS road safety and security applications;

—

IV.

Linking the vehicle with the transport infrastructure.

2.   The scope of the priority areas is specified in Annex I.

Article 3

Priority actions

Within the priority areas the following shall constitute priority actions for the development and use of specifications and standards, as set out in Annex I:

| (a) | the provision of EU-wide multimodal travel information services; |
| --- | --- |

(a)

the provision of EU-wide multimodal travel information services;

| (b) | the provision of EU-wide real-time traffic information services; |
| --- | --- |

(b)

the provision of EU-wide real-time traffic information services;

| (c) | data and procedures for the provision, where possible, of road safety related minimum universal traffic information free of charge to users; |
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(c)

data and procedures for the provision, where possible, of road safety related minimum universal traffic information free of charge to users;

| (d) | the harmonised provision for an interoperable EU-wide eCall; |
| --- | --- |

(d)

the harmonised provision for an interoperable EU-wide eCall;

| (e) | the provision of information services for safe and secure parking places for trucks and commercial vehicles; |
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(e)

the provision of information services for safe and secure parking places for trucks and commercial vehicles;

| (f) | the provision of reservation services for safe and secure parking places for trucks and commercial vehicles. |
| --- | --- |

(f)

the provision of reservation services for safe and secure parking places for trucks and commercial vehicles.

Article 4

Definitions

For the purposes of this Directive, the following definitions shall apply:

| (1) | ‘Intelligent Transport Systems’ or ‘ITS’ means systems in which information and communication technologies are applied in the field of road transport, including infrastructure, vehicles and users, and in traffic management and mobility management, as well as for interfaces with other modes of transport; |
| --- | --- |

(1)

‘Intelligent Transport Systems’ or ‘ITS’ means systems in which information and communication technologies are applied in the field of road transport, including infrastructure, vehicles and users, and in traffic management and mobility management, as well as for interfaces with other modes of transport;

| (2) | ‘interoperability’ means the capacity of systems and the underlying business processes to exchange data and to share information and knowledge; |
| --- | --- |

(2)

‘interoperability’ means the capacity of systems and the underlying business processes to exchange data and to share information and knowledge;

| (3) | ‘ITS application’ means an operational instrument for the application of ITS; |
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(3)

‘ITS application’ means an operational instrument for the application of ITS;

| (4) | ‘ITS service’ means the provision of an ITS application through a well-defined organisational and operational framework with the aim of contributing to user safety, efficiency, comfort and/or to facilitate or support transport and travel operations; |
| --- | --- |

(4)

‘ITS service’ means the provision of an ITS application through a well-defined organisational and operational framework with the aim of contributing to user safety, efficiency, comfort and/or to facilitate or support transport and travel operations;

| (5) | ‘ITS service provider’ means any provider of an ITS service, whether public or private; |
| --- | --- |

(5)

‘ITS service provider’ means any provider of an ITS service, whether public or private;

| (6) | ‘ITS user’ means any user of ITS applications or services including travellers, vulnerable road users, road transport infrastructure users and operators, fleet managers and operators of emergency services; |
| --- | --- |

(6)

‘ITS user’ means any user of ITS applications or services including travellers, vulnerable road users, road transport infrastructure users and operators, fleet managers and operators of emergency services;

| (7) | ‘Vulnerable road users’ means non-motorised road users, such as pedestrians and cyclists as well as motor-cyclists and persons with disabilities or reduced mobility and orientation; |
| --- | --- |

(7)

‘Vulnerable road users’ means non-motorised road users, such as pedestrians and cyclists as well as motor-cyclists and persons with disabilities or reduced mobility and orientation;

| (8) | ‘nomadic device’ means a portable communication or information device that can be brought inside the vehicle to support the driving task and/or the transport operations; |
| --- | --- |

(8)

‘nomadic device’ means a portable communication or information device that can be brought inside the vehicle to support the driving task and/or the transport operations;

| (9) | ‘platform’ means an on-board or off-board unit enabling the deployment, provision, exploitation and integration of ITS applications and services; |
| --- | --- |

(9)

‘platform’ means an on-board or off-board unit enabling the deployment, provision, exploitation and integration of ITS applications and services;

| (10) | ‘architecture’ means the conceptual design that defines the structure, behaviour and integration of a given system in its surrounding context; |
| --- | --- |

(10)

‘architecture’ means the conceptual design that defines the structure, behaviour and integration of a given system in its surrounding context;

| (11) | ‘interface’ means a facility between systems which provides the media through which they can connect and interact; |
| --- | --- |

(11)

‘interface’ means a facility between systems which provides the media through which they can connect and interact;

| (12) | ‘compatibility’ means the general ability of a device or system to work with another device or system without modification; |
| --- | --- |

(12)

‘compatibility’ means the general ability of a device or system to work with another device or system without modification;

| (13) | ‘continuity of services’ means the ability to ensure seamless services on transport networks across the Union; |
| --- | --- |

(13)

‘continuity of services’ means the ability to ensure seamless services on transport networks across the Union;

| (14) | ‘road data’ means data on road infrastructure characteristics, including fixed traffic signs or their regulatory safety attributes; |
| --- | --- |

(14)

‘road data’ means data on road infrastructure characteristics, including fixed traffic signs or their regulatory safety attributes;

| (15) | ‘traffic data’ means historic and real-time data on road traffic characteristics; |
| --- | --- |

(15)

‘traffic data’ means historic and real-time data on road traffic characteristics;

| (16) | ‘travel data’ means basic data such as public transport timetables and tariffs, necessary to provide multi-modal travel information before and during the trip to facilitate travel planning, booking and adaptation; |
| --- | --- |

(16)

‘travel data’ means basic data such as public transport timetables and tariffs, necessary to provide multi-modal travel information before and during the trip to facilitate travel planning, booking and adaptation;

| (17) | ‘specification’ means a binding measure laying down provisions containing requirements, procedures or any other relevant rules; |
| --- | --- |

(17)

‘specification’ means a binding measure laying down provisions containing requirements, procedures or any other relevant rules;

| (18) | ‘standard’ means standard as defined in Article 1(6) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (16). |
| --- | --- |

(18)

‘standard’ means standard as defined in Article 1(6) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (16).

Article 5

Deployment of ITS

1.   Member States shall take the necessary measures to ensure that the specifications adopted by the Commission in accordance with Article 6 are applied to ITS applications and services, when these are deployed, in accordance with the principles in Annex II. This is without prejudice to the right of each Member State to decide on its deployment of such applications and services on its territory. This right is without prejudice to any legislative act adopted under the second subparagraph of Article 6(2).

2.   Member States shall also make efforts to co-operate in respect of the priority areas, insofar as no specifications have been adopted.

Article 6

Specifications

1.   The Commission shall first adopt the specifications necessary to ensure the compatibility, interoperability and continuity for the deployment and operational use of ITS for the priority actions.

2.   The Commission shall aim at adopting specifications for one or more of the priority actions by ... (17).

At the latest 12 months after the adoption of the necessary specifications for a priority action, the Commission shall, where appropriate, after conducting an impact assessment including a cost-benefit analysis, present a proposal to the European Parliament and the Council in accordance with Article 294 of the TFEU on the deployment of that priority action.

3.   Once the necessary specifications for the priority actions have been adopted, the Commission shall adopt specifications ensuring compatibility, interoperability and continuity for the deployment and operational use of ITS for other actions in the priority areas.

4.   Where relevant, and depending on the area covered by the specification, the specification shall include one or more of the following types of provisions:

| (a) | functional provisions that describe the roles of the various stakeholders and the information flow between them; |
| --- | --- |

(a)

functional provisions that describe the roles of the various stakeholders and the information flow between them;

| (b) | technical provisions that provide for the technical means to fulfil the functional provisions; |
| --- | --- |

(b)

technical provisions that provide for the technical means to fulfil the functional provisions;

| (c) | organisational provisions that describe the procedural obligations of the various stakeholders; |
| --- | --- |

(c)

organisational provisions that describe the procedural obligations of the various stakeholders;

| (d) | service provisions that describe the various levels of services and their content for ITS applications and services. |
| --- | --- |

(d)

service provisions that describe the various levels of services and their content for ITS applications and services.

5.   Without prejudice to the procedures under Directive 98/34/EC the specifications shall, where appropriate, stipulate the conditions in which Member States may, after notification to the Commission, establish additional rules for the provision of ITS services on all or part of their territory, provided that those rules do not hinder interoperability.

6.   The specifications shall, where appropriate, be based on any standards referred to in Article 8.

The specifications shall, as appropriate, provide for conformity assessment in accordance with Decision No 768/2008/EC.

The specifications shall comply with the principles set out in Annex II.

7.   The Commission shall conduct an impact assessment including a cost-benefit analysis prior to the adoption of the specifications.

Article 7

Delegated acts

1.   The Commission may adopt delegated acts in accordance with Article 290 of the TFEU as regards specifications. When adopting such delegated acts the Commission shall act in accordance with the relevant provisions of this Directive, in particular Article 6 and Annex II.

2.   A separate delegated act shall be adopted for each of the priority actions.

3.   For the delegated acts referred to in this Article, the procedure set out in Articles 12, 13 and 14 shall apply.

Article 8

Standards

1.   The necessary standards to provide for interoperability, compatibility and continuity for the deployment and operational use of ITS shall be developed in the priority areas and for the priority actions. To that effect, the Commission, after having consulted the Committee referred to in Article 15, shall request the relevant standardisation bodies in accordance with the procedure laid down in Directive 98/34/EC to make every necessary effort to adopt these standards rapidly.

2.   When issuing a mandate to the standardisation bodies, the principles set out in Annex II shall be observed as well as any functional provision included in a specification adopted in accordance with Article 6.

Article 9

Non-binding measures

The Commission may adopt guidelines and other non-binding measures to facilitate Member States' co-operation relating to the priority areas in accordance with the advisory procedure referred to in Article 15(2).

Article 10

Rules on privacy, security and re-use of information

1.   Member States shall ensure that the processing of personal data in the context of the operation of ITS applications and services is carried out in accordance with Union rules protecting fundamental rights and freedoms of individuals, in particular Directive 95/46/EC and Directive 2002/58/EC.

2.   In particular, Member States shall ensure that personal data are protected against misuse, including unlawful access, alteration or loss.

3.   Without prejudice to paragraph 1, in order to ensure privacy, the use of anonymous data shall be encouraged, where appropriate, for the performance of the ITS applications and services.

Without prejudice to Directive 95/46/EC personal data shall, only be processed insofar as such processing is necessary for the performance of ITS applications and services.

4.   With regard to the application of Directive 95/46/EC and in particular where special categories of personal data are involved, Member States shall also ensure that the provisions on consent to the processing of such personal data are respected.

5.   Directive 2003/98/EC shall apply.

Article 11

Rules on liability

Member States shall ensure that issues related to liability, concerning the deployment and use of ITS applications and services set out in specifications adopted in accordance with Article 6, are addressed in accordance with Union law, including in particular Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (18) as well as relevant national legislation.

Article 12

Exercise of the delegation

1.   The power to adopt the delegated acts referred to in Article 7 shall be conferred on the Commission for a period of seven years following ... (19). The Commission shall make a report in respect of the delegated powers no later than six months before the end of a five year period following ... (19).

2.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

3.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 13 and 14.

Article 13

Revocation of the delegation

1.   The delegation of powers referred to in Article 7 may be revoked by the European Parliament or by the Council.

2.   The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.

3.   The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

Article 14

Objections to delegated acts

1.   The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification.

At the initiative of the European Parliament or the Council this period shall be extended by two months.

2.   If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.

The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.

3.   If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

Article 15

Committee procedure

1.   The Commission shall be assisted by the European ITS Committee (EIC).

2.   Where reference is made to this paragraph, Article 3 and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 16

European ITS Advisory Group

The Commission shall establish a European ITS Advisory Group to advise it on business and technical aspects of the deployment and use of ITS in the Union. The group shall be composed of high level representatives from relevant ITS service providers, associations of users, transport and facilities operators, manufacturing industry, social partners, professional associations, local authorities and other relevant fora.

Article 17

Reporting

1.   Member States shall submit to the Commission by ... (20) a report on their national activities and projects regarding the priority areas.

2.   Member States shall provide the Commission by ... (21) with information on national ITS actions envisaged over the following five year period.

Guidelines for reporting by the Member States shall be adopted in accordance with the advisory procedure referred to in Article 15(2).

3.   Following the initial report, Member States shall report every three years on the progress made in the deployment of the actions referred to in paragraph 1.

4.   The Commission shall submit a report every three years to the European Parliament and to the Council on the progress made for the implementation of this Directive. The report shall be accompanied by an analysis on the functioning and implementation, including the financial resources used and needed, of Articles 5 to 11 and Article 16, and shall assess the need to amend this Directive, where appropriate.

5.   In accordance with the advisory procedure referred to in Article 15(2), the Commission shall adopt a working program by ... (22). The working program shall include objectives and dates for its implementation every year and if necessary shall propose the necessary adaptations.

Article 18

Transposition

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... (23).

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference, and its wording, shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 19

Entry into force

This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Article 20

Addressees

This Directive is addressed to the Member States.

Done at ...

For the European Parliament

The President

...

For the Council

The President

...

---

(1)  OJ C 277, 17.11.2009, p. 85.

1

(2)  Position of the European Parliament of 23 April 2009 (not yet published in the Official Journal), position of the Council of 10 May 2010, position of the European Parliament of ... (not yet published in the Official Journal) (and decision of the Council of ...).

2

(3)  OJ L 281, 23.11.1995, p. 31.

3

(4)  OJ L 201, 31.7.2002, p. 37.

4

(5)  OJ L 345, 31.12.2003, p. 90.

5

(6)  OJ L 218, 13.8.2008, p. 82.

6

(7)  OJ L 263, 9.10.2007, p. 1.

7

(8)  OJ L 124, 9.5.2002, p. 1.

8

(9)  OJ L 171, 9.7.2003, p. 1.

9

(10)  OJ L 3, 5.1.2005, p. 1.

10

(11)  OJ L 196, 24.7.2008, p. 1.

11

(12)  OJ L 184, 17.7.1999, p. 23.

12

(13)  OJ L 166, 30.4.2004, p. 124.

13

(14)  OJ L 370, 31.12.1985, p. 8.

14

(15)  OJ L 108, 25.4.2007, p. 1.

15

(16)  OJ L 204, 21.7.1998, p. 37.

16

(17)  30 months following the date of entry into force of this Directive.

17

(18)  OJ L 210, 7.8.1985, p. 29.

18

(19)  The date of the entry into force of the Directive.

19

(20)  12 months following the entry into force of this Directive.

20

(21)  Two years following the entry into force of this Directive.

21

(22)  Six months following the entry into force of this Directive.

22

(23)  18 months following the entry into force of this Directive.

23

---

ANNEX I

PRIORITY AREAS AND ACTIONS

(as referred to in Articles 2 and 3)

Priority area I: Optimal use of road, traffic and travel data

The specifications and standards for an optimal use of road, traffic and travel data shall include the following:

1.   Specifications for priority action (a)

The definition of the necessary requirements to make EU-wide multimodal travel information services accurate and available across borders to ITS users, based on:

| — | the availability and accessibility of existing and accurate road and real-time traffic data used for multimodal travel information to ITS service providers without prejudice to safety and transport management constraints; |
| --- | --- |

—

the availability and accessibility of existing and accurate road and real-time traffic data used for multimodal travel information to ITS service providers without prejudice to safety and transport management constraints;

| — | the facilitation of the electronic data exchange between the relevant public authorities and stakeholders and the relevant ITS service providers, across borders; |
| --- | --- |

—

the facilitation of the electronic data exchange between the relevant public authorities and stakeholders and the relevant ITS service providers, across borders;

| — | the timely updating of available road and traffic data used for multimodal travel information by the relevant public authorities and stakeholders; |
| --- | --- |

—

the timely updating of available road and traffic data used for multimodal travel information by the relevant public authorities and stakeholders;

| — | the timely updating of multimodal travel information by the ITS service providers. |
| --- | --- |

—

the timely updating of multimodal travel information by the ITS service providers.

2.   Specifications for priority action (b)

The definition of the necessary requirements to make EU-wide real-time traffic information services accurate and available across borders to ITS users, based on:

| — | the availability and accessibility of existing and accurate road and real-time traffic data used for real-time traffic information to ITS service providers without prejudice to safety and transport management constraints; |
| --- | --- |

—

the availability and accessibility of existing and accurate road and real-time traffic data used for real-time traffic information to ITS service providers without prejudice to safety and transport management constraints;

| — | the facilitation of the electronic data exchange between the relevant public authorities and stakeholders and the relevant ITS service providers, across borders; |
| --- | --- |

—

the facilitation of the electronic data exchange between the relevant public authorities and stakeholders and the relevant ITS service providers, across borders;

| — | the timely updating of available road and traffic data used for real-time traffic information by the relevant public authorities and stakeholders; |
| --- | --- |

—

the timely updating of available road and traffic data used for real-time traffic information by the relevant public authorities and stakeholders;

| — | the timely updating of real-time traffic information by the ITS service providers. |
| --- | --- |

—

the timely updating of real-time traffic information by the ITS service providers.

3.   Specifications for priority actions (a) and (b)

3.1.   The definition of the necessary requirements for the collection by relevant public authorities and/or, where relevant, by the private sector of road and traffic data (i.e. traffic circulation plans, traffic regulations and recommended routes, notably for heavy goods vehicles) and for their provisioning to ITS service providers, based on:

| — | the availability, to ITS service providers, of existing road and traffic data (i.e. traffic circulation plans, traffic regulations and recommended routes) collected by the relevant public authorities and/or the private sector; |
| --- | --- |

—

the availability, to ITS service providers, of existing road and traffic data (i.e. traffic circulation plans, traffic regulations and recommended routes) collected by the relevant public authorities and/or the private sector;

| — | the facilitation of the electronic data exchange between the relevant public authorities and the ITS service providers; |
| --- | --- |

—

the facilitation of the electronic data exchange between the relevant public authorities and the ITS service providers;

| — | the timely updating, by the relevant public authorities and/or, where relevant, the private sector, of road and traffic data (i.e. traffic circulation plans, traffic regulations and recommended routes); |
| --- | --- |

—

the timely updating, by the relevant public authorities and/or, where relevant, the private sector, of road and traffic data (i.e. traffic circulation plans, traffic regulations and recommended routes);

| — | the timely updating, by the ITS service providers, of the ITS services and applications using these road and traffic data. |
| --- | --- |

—

the timely updating, by the ITS service providers, of the ITS services and applications using these road and traffic data.

3.2.   The definition of the necessary requirements to make road, traffic and transport services data used for digital maps accurate and available, where possible, to digital map producers and service providers, based on:

| — | the availability of existing road and traffic data used for digital maps to digital map producers and service providers; |
| --- | --- |

—

the availability of existing road and traffic data used for digital maps to digital map producers and service providers;

| — | the facilitation of the electronic data exchange between the relevant public authorities and stakeholders and the private digital map producers and service providers; |
| --- | --- |

—

the facilitation of the electronic data exchange between the relevant public authorities and stakeholders and the private digital map producers and service providers;

| — | the timely updating of road and traffic data for digital maps by the relevant public authorities and stakeholders; |
| --- | --- |

—

the timely updating of road and traffic data for digital maps by the relevant public authorities and stakeholders;

| — | the timely updating of the digital maps by the digital map producers and service providers. |
| --- | --- |

—

the timely updating of the digital maps by the digital map producers and service providers.

4.   Specifications for priority action (c)

The definition of minimum requirements, for road safety related ‘universal traffic information’ provided, where possible, free of charge to all users, as well as their minimum content, based on:

| — | the identification and use of a standardised list of safety related traffic events (‘universal traffic messages’) which should be communicated to ITS users free of charge; |
| --- | --- |

—

the identification and use of a standardised list of safety related traffic events (‘universal traffic messages’) which should be communicated to ITS users free of charge;

| — | The compatibility and the integration of ‘universal traffic messages’ into ITS services for real-time traffic and multimodal travel information. |
| --- | --- |

—

The compatibility and the integration of ‘universal traffic messages’ into ITS services for real-time traffic and multimodal travel information.

Priority area II: Continuity of traffic and freight management ITS services

The specifications and standards for the continuity and interoperability of traffic and freight management services, in particular on the TEN-T network, shall include the following:

1.   Specifications for other actions

1.1.   The definition of the necessary measures to develop an EU ITS Framework Architecture, addressing specifically ITS-related interoperability, continuity of services and multi-modality aspects, including for example multimodal interoperable ticketing, within which Member States and their competent authorities in cooperation with the private sector can develop their own ITS architecture for mobility at national, regional or local level.

1.2.   The definition of the minimum necessary requirements for the continuity of ITS services, in particular for cross-border services, for the management of passenger transport across different modes of transport, based on:

| — | the facilitation of the electronic exchange for traffic data and information across borders, and where appropriate, regions, or between urban and inter-urban areas between the relevant traffic information/control centres and different stakeholders; |
| --- | --- |

—

the facilitation of the electronic exchange for traffic data and information across borders, and where appropriate, regions, or between urban and inter-urban areas between the relevant traffic information/control centres and different stakeholders;

| — | the use of standardised information flows or traffic interfaces between the relevant traffic information/control centres and different stakeholders. |
| --- | --- |

—

the use of standardised information flows or traffic interfaces between the relevant traffic information/control centres and different stakeholders.

1.3.   The definition of the minimum necessary requirements for the continuity of ITS services for the management of freight along transport corridors and across different modes of transport, based on:

| — | the facilitation of the electronic exchange for traffic data and information across borders, and where appropriate, regions, or between urban and inter-urban areas between the relevant traffic information/control centres and different stakeholders; |
| --- | --- |

—

the facilitation of the electronic exchange for traffic data and information across borders, and where appropriate, regions, or between urban and inter-urban areas between the relevant traffic information/control centres and different stakeholders;

| — | the use of standardised information flows or traffic interfaces between the relevant traffic information/control centres and different stakeholders. |
| --- | --- |

—

the use of standardised information flows or traffic interfaces between the relevant traffic information/control centres and different stakeholders.

1.4.   The definition of the necessary measures in the realisation of ITS applications (notably the tracking and tracing of freight along its journey and across modes of transport) for freight transport logistics (eFreight), based on:

| — | the availability of relevant ITS technologies to and their use by ITS application developers; |
| --- | --- |

—

the availability of relevant ITS technologies to and their use by ITS application developers;

| — | the integration of positioning results in the traffic management tools and centres. |
| --- | --- |

—

the integration of positioning results in the traffic management tools and centres.

1.5.   The definition of the necessary interfaces to ensure interoperability and compatibility between the urban ITS architecture and the European ITS architecture based on:

| — | the availability of public transport, travel planning, transport demand, traffic data and parking data to urban control centres and service providers; |
| --- | --- |

—

the availability of public transport, travel planning, transport demand, traffic data and parking data to urban control centres and service providers;

| — | the facilitation of the electronic data exchange between the different urban control centres and service providers for public or private transport and through all possible modes of transport; |
| --- | --- |

—

the facilitation of the electronic data exchange between the different urban control centres and service providers for public or private transport and through all possible modes of transport;

| — | the integration of all relevant data and information in a single architecture. |
| --- | --- |

—

the integration of all relevant data and information in a single architecture.

Priority area III: ITS road safety and security applications

The specifications and standards for ITS road safety and security applications shall include the following:

1.   Specifications for priority action (d)

The definition of the necessary measures for the harmonised provision of an interoperable EU-wide eCall, including:

| — | the availability of the required in-vehicle ITS data to be exchanged; |
| --- | --- |

—

the availability of the required in-vehicle ITS data to be exchanged;

| — | the availability of the necessary equipment in the emergency call response centres receiving the data emitted from the vehicles; |
| --- | --- |

—

the availability of the necessary equipment in the emergency call response centres receiving the data emitted from the vehicles;

| — | the facilitation of the electronic data exchange between the vehicles and the emergency call response centres. |
| --- | --- |

—

the facilitation of the electronic data exchange between the vehicles and the emergency call response centres.

2.   Specifications for priority action (e)

The definition of the necessary measures to provide ITS based information services for safe and secure parking places for trucks and commercial vehicles, in particular in service and rest areas on roads, based on:

| — | the availability of the road parking information to users; |
| --- | --- |

—

the availability of the road parking information to users;

| — | the facilitation of the electronic data exchange between road parking sites, centres and vehicles. |
| --- | --- |

—

the facilitation of the electronic data exchange between road parking sites, centres and vehicles.

3.   Specifications for priority action (f)

The definition of the necessary measures to provide ITS based reservation services for safe and secure parking places for trucks and commercial vehicles based on:

| — | the availability of the road parking information to users; |
| --- | --- |

—

the availability of the road parking information to users;

| — | the facilitation of the electronic data exchange between road parking sites, centres and vehicles; |
| --- | --- |

—

the facilitation of the electronic data exchange between road parking sites, centres and vehicles;

| — | the integration of relevant ITS technologies in both vehicles and road parking facilities to update the information on available parking space for reservation purposes. |
| --- | --- |

—

the integration of relevant ITS technologies in both vehicles and road parking facilities to update the information on available parking space for reservation purposes.

4.   Specifications for other actions

4.1.   The definition of the necessary measures to support the safety of road users with respect to their on-board Human-Machine-Interface and the use of nomadic devices to support the driving task and/or the transport operation, as well as the security of the in-vehicle communications.

4.2.   The definition of the necessary measures to improve the safety and comfort of vulnerable road users for all relevant ITS applications.

4.3.   The definition of necessary measures to integrate advanced driver support information systems into vehicles and road infrastructure which fall outside the scope of Directives 2007/46/EC, 2002/24/EC and 2003/37/EC.

Priority area IV: Linking the vehicle with the transport infrastructure

The specifications and standards for linking vehicles with the transport infrastructure shall include the following:

1.   Specifications for other actions

1.1.   The definition of necessary measures to integrate different ITS applications on an open in-vehicle platform, based on:

| — | the identification of functional requirements of existing or planned ITS applications; |
| --- | --- |

—

the identification of functional requirements of existing or planned ITS applications;

| — | the definition of an open-system architecture which defines the functionalities and interfaces necessary for the interoperability/interconnection with infrastructure systems and facilities; |
| --- | --- |

—

the definition of an open-system architecture which defines the functionalities and interfaces necessary for the interoperability/interconnection with infrastructure systems and facilities;

| — | the integration of future new or upgraded ITS applications in a ‘plug and play’ manner into an open in-vehicle platform; |
| --- | --- |

—

the integration of future new or upgraded ITS applications in a ‘plug and play’ manner into an open in-vehicle platform;

| — | the use of a standardisation process for the adoption of the architecture, and the open in-vehicle specifications. |
| --- | --- |

—

the use of a standardisation process for the adoption of the architecture, and the open in-vehicle specifications.

1.2.   The definition of necessary measures to further progress the development and implementation of cooperative (vehicle-vehicle, vehicle-infrastructure, infrastructure-infrastructure) systems, based on:

| — | the facilitation of the exchange of data or information between vehicles, infrastructures and between vehicle and infrastructure; |
| --- | --- |

—

the facilitation of the exchange of data or information between vehicles, infrastructures and between vehicle and infrastructure;

| — | the availability of the relevant data or information to be exchanged to the respective vehicle or road infrastructure parties; |
| --- | --- |

—

the availability of the relevant data or information to be exchanged to the respective vehicle or road infrastructure parties;

| — | the use of a standardised message format for the exchange of data or information between the vehicle and the infrastructure; |
| --- | --- |

—

the use of a standardised message format for the exchange of data or information between the vehicle and the infrastructure;

| — | the definition of a communication infrastructure for data or information exchange between vehicles, infrastructures and between vehicle and infrastructure; |
| --- | --- |

—

the definition of a communication infrastructure for data or information exchange between vehicles, infrastructures and between vehicle and infrastructure;

| — | the use of standardisation processes to adopt the respective architectures. |
| --- | --- |

—

the use of standardisation processes to adopt the respective architectures.

---

ANNEX II

PRINCIPLES FOR SPECIFICATIONS AND DEPLOYMENT OF ITS

(as referred to in Articles 5, 6 and 8)

The adoption of specifications, the issuing of mandates for standards and the selection and deployment of ITS applications and services shall be based upon an evaluation of needs involving all relevant stakeholders, and shall comply with the following principles. These measures shall:

| (a) | Be Effective – make a tangible contribution towards solving the key challenges affecting road transportation in Europe (e.g. reducing congestion, lowering of emissions, improving energy efficiency, attaining higher levels of safety and security including vulnerable road users); |
| --- | --- |

(a)

Be Effective – make a tangible contribution towards solving the key challenges affecting road transportation in Europe (e.g. reducing congestion, lowering of emissions, improving energy efficiency, attaining higher levels of safety and security including vulnerable road users);

| (b) | Be Cost-efficient – optimise the ratio of costs in relation to output with regard to meeting objectives; |
| --- | --- |

(b)

Be Cost-efficient – optimise the ratio of costs in relation to output with regard to meeting objectives;

| (c) | Be proportionate – provide, where appropriate, for different levels of achievable service quality and deployment, taking into account the local, regional, national and European specificities; |
| --- | --- |

(c)

Be proportionate – provide, where appropriate, for different levels of achievable service quality and deployment, taking into account the local, regional, national and European specificities;

| (d) | Support continuity of services – ensure seamless services across the Union, in particular on the trans-European network, and where possible at its external borders, when ITS services are deployed. Continuity of services should be ensured at a level adapted to the characteristics of the transport networks linking countries with countries, and where appropriate, regions with regions and cities with rural areas; |
| --- | --- |

(d)

Support continuity of services – ensure seamless services across the Union, in particular on the trans-European network, and where possible at its external borders, when ITS services are deployed. Continuity of services should be ensured at a level adapted to the characteristics of the transport networks linking countries with countries, and where appropriate, regions with regions and cities with rural areas;

| (e) | Deliver Interoperability – ensure that systems and the underlying business processes have the capacity to exchange data and to share information and knowledge to enable effective ITS service delivery; |
| --- | --- |

(e)

Deliver Interoperability – ensure that systems and the underlying business processes have the capacity to exchange data and to share information and knowledge to enable effective ITS service delivery;

| (f) | Support backward compatibility – ensure, where appropriate, the capability for ITS systems to work with existing systems that share a common purpose, without hindering the development of new technologies; |
| --- | --- |

(f)

Support backward compatibility – ensure, where appropriate, the capability for ITS systems to work with existing systems that share a common purpose, without hindering the development of new technologies;

| (g) | Respect existing national infrastructure and network characteristics – take into account the inherent differences in the transport network characteristics, in particular in the sizes of the traffic volumes and in road weather conditions; |
| --- | --- |

(g)

Respect existing national infrastructure and network characteristics – take into account the inherent differences in the transport network characteristics, in particular in the sizes of the traffic volumes and in road weather conditions;

| (h) | Promote equality of access – do not impede or discriminate against access to ITS applications and services by vulnerable road users; |
| --- | --- |

(h)

Promote equality of access – do not impede or discriminate against access to ITS applications and services by vulnerable road users;

| (i) | Support maturity – demonstrate, after appropriate risk assessment, the robustness of innovative ITS systems, through a sufficient level of technical development and operational exploitation; |
| --- | --- |

(i)

Support maturity – demonstrate, after appropriate risk assessment, the robustness of innovative ITS systems, through a sufficient level of technical development and operational exploitation;

| (j) | Deliver Quality of timing and positioning – use of satellite-based infrastructures, or any technology providing equivalent levels of precision for the purposes of ITS applications and services that require global, continuous, accurate and guaranteed timing and positioning services; |
| --- | --- |

(j)

Deliver Quality of timing and positioning – use of satellite-based infrastructures, or any technology providing equivalent levels of precision for the purposes of ITS applications and services that require global, continuous, accurate and guaranteed timing and positioning services;

| (k) | Facilitate Inter-modality – take into account the coordination of various modes of transport, where appropriate, when deploying ITS; |
| --- | --- |

(k)

Facilitate Inter-modality – take into account the coordination of various modes of transport, where appropriate, when deploying ITS;

| (l) | Respect Coherence – take into account existing Union rules, policies and activities which are relevant in the field of ITS, in particular in the field of standardisation. |
| --- | --- |

(l)

Respect Coherence – take into account existing Union rules, policies and activities which are relevant in the field of ITS, in particular in the field of standardisation.

---

STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

1.   On 16 December 2008 the Commission adopted a proposal for a Directive of the European Parliament and of the Council on establishing a framework for the accelerated deployment of ITS (1) across the EU and a related Action Plan.

2.   The European Economic and Social Committee delivered its opinion on the proposal on 13 April 2009. The European Committee of the Regions was consulted, however, did not issue an opinion.

3.   The European Parliament adopted its opinion (2) at first reading on 23 April 2009, approving 57 amendments. The Commission did not present a modified proposal.

4.   The European Data Protection Supervisor gave its opinion on the Commission proposal on 22 July 2009 (3).

5.   On 10 May 2010, the Council adopted its position at first reading, in accordance with the ordinary legislative procedure laid down in Article 294 of the Treaty on the Functioning of the European Union.

II.   OBJECTIVE OF THE PROPOSAL

6.   The general objective of this proposal is to create the conditions and, in particular, to put in place the necessary mechanisms to foster the uptake of Intelligent Transport Systems (ITS) services and applications for road transport and their interfaces with other modes of transport in order to have ITS contributing at its full potential towards the various EU policies.

III.   ANALYSIS OF THE COMMON POSITION

7.   General

The mid-term review of the European Commission's 2001 White Paper on Transport Policy, ‘Keep Europe Moving’ (4), highlighted the importance of intelligent transport, and stressed the need to face growing challenges regarding a sustainable road transport system. Intelligent Transport Systems, as a result of applying emerging information and communication technologies to transport, have the potential to contribute to a safe, efficient, sustainable, inclusive and seamless transport of goods and people on the European road network and its interfaces with the other transport modes and to improve the competitiveness of European industry. The Commission proposal aimed at unlocking the full potential of ITS in serving EU policies in the field of enhanced road safety, improved transport efficiency and reduced environmental impact and to create the momentum necessary to speed up market penetration of rather mature ITS applications and services. To this end, the proposal foresaw to apply the comitology procedure (regulatory procedure with scrutiny) for establishing common and legally binding specifications defining detailed provisions and procedures for the deployment of ITS across the EU.

Although the Council agreed with the Commission as regards the objective of the proposal, the Council’s approach involves major adaptations of the original proposal on the following issues:

| — | Specification and definition of the areas in which specifications may be adopted, |
| --- | --- |

—

Specification and definition of the areas in which specifications may be adopted,

| — | Prioritisation of certain actions within the aforementioned areas for the adoption of specifications, |
| --- | --- |

—

Prioritisation of certain actions within the aforementioned areas for the adoption of specifications,

| — | Clarification of Member States' obligations for the deployment and use of ITS applications and services, |
| --- | --- |

—

Clarification of Member States' obligations for the deployment and use of ITS applications and services,

| — | New articles on ‘non-binding measures’ and ‘standards’. |
| --- | --- |

—

New articles on ‘non-binding measures’ and ‘standards’.

Resulting from this approach, the Council first reading position modifies the original Commission proposal by redrafting it and deleting and/or adding several provisions to the text.

By proposing a step-wise approach for the deployment and use of ITS applications and services, the Council strikes a delicate balance of boosting the development, deployment and use of certain ITS services and applications while not adding further administrative and financial burdens to Member States.

8.   Main issues

Subject matter and scope

The Commission proposed to establish a framework for the coordinated deployment and use of intelligent transport systems within the Community and the development of specifications necessary for that purpose.

The European Parliament followed largely the Commission proposal to establish such framework for the coordinated and coherent deployment and use of intelligent transport systems, including interoperable ITS, within the Union. The EP proposed that this directive should apply to all intelligent transport systems for travellers, vehicles and infrastructure and their interaction in the field of road transport, including urban transport. Moreover, the EP proposed to include also vulnerable transport users under the scope of the directive, but to exclude matters related to public order and public security from it.

The Council position at first reading specifies that the proposed framework shall be in support of the coordinated and coherent use of ITS, in particular across the borders between Member States. The Council, in line with the EP, foresees that this directive shall not prejudge matters of national security or of interest of defence.

Priority areas

In the Commission proposal four priority areas (optimal use of road, traffic and travel data, continuity of traffic and freight management ITS services on European Transport corridors and conurbations, road safety and security, and integration of the vehicle into the transport infrastructure) were listed in which the Commission should, in particular, define specifications for the deployment and use of ITS applications and services.

The European Parliament confirmed the above priority areas, but deleted the possibility to adopt specifications in other areas than the four listed above.

The Council position at first reading conforms largely with the position of the European Parliament and foresees an article on its own for the following four priority areas:

| I. | Optimal use of road, traffic and travel data |
| --- | --- |

I.

Optimal use of road, traffic and travel data

| II. | Continuity of traffic and freight management ITS services |
| --- | --- |

II.

Continuity of traffic and freight management ITS services

| III. | ITS road safety and security applications |
| --- | --- |

III.

ITS road safety and security applications

| IV. | Linking the vehicle with the transport infrastructure. |
| --- | --- |

IV.

Linking the vehicle with the transport infrastructure.

The scope of these priority areas is specified in Annex II of the directive.

Priority actions

The Commission proposal did not foresee priority actions.

The European Parliament did not establish priority actions either. However, the European Parliament defined four areas (the provision of EU-wide real-time traffic and travel information services, data and procedures for the provision of free minimum universal traffic information services, the harmonised introduction of e-Call throughout Europe and appropriate measures on secure parking places for trucks and commercial vehicles and on telematics-controlled parking and reservation systems) in which the Commission should define specifications for the obligatory deployment and use of the minimum level of ITS applications and services.

The Council position at first reading picks up the idea of the European Parliament to give priority to certain ITS applications and services. To this end, the Council sets up the following six priority actions:

| (a) | the provision of EU-wide multimodal travel information services |
| --- | --- |

(a)

the provision of EU-wide multimodal travel information services

| (b) | the provision of EU-wide real-time traffic information services |
| --- | --- |

(b)

the provision of EU-wide real-time traffic information services

| (c) | data and procedures for the provision, where possible, of road safety related minimum universal traffic information free of charge to users |
| --- | --- |

(c)

data and procedures for the provision, where possible, of road safety related minimum universal traffic information free of charge to users

| (d) | the harmonised provision for an interoperable EU-wide e-Call |
| --- | --- |

(d)

the harmonised provision for an interoperable EU-wide e-Call

| (e) | the provision of information services for safe and secure parking places for trucks and commercial vehicles |
| --- | --- |

(e)

the provision of information services for safe and secure parking places for trucks and commercial vehicles

| (f) | the provision of reservation services for safe and secure parking places for trucks and commercial vehicles. |
| --- | --- |

(f)

the provision of reservation services for safe and secure parking places for trucks and commercial vehicles.

Deployment of ITS applications and services

The Commission proposal foresaw that the Member States take the necessary measures for a coordinated deployment and use of interoperable ITS applications and services within the Union. To this end, the Commission proposed to adopt specifications through the comitology procedure (regulatory procedure with scrutiny) which might also entail obligations for Member States to deploy ITS applications and services.

The European Parliament followed largely the Commission proposal by strengthening the respective wording to avoid geographical fragmentation and discontinuity of ITS applications and services. The EP specified that Member States should ensure the backward compatibility of ITS applications and services within the Union. The EP proposed also that Member States should apply ITS to all modes of transport and to the interfaces between them, ensuring a high level of integration between all transport modes. Moreover, the EP foresaw that Members States should take the necessary measures for requiring the compliance with the basic principles set (effectiveness, cost-efficiency, geographical continuity, interoperability and degree of maturity) for the evaluation of needs. To this end, Member States should also take account of the morphological particularities of geographically isolated regions and the distances that have to be covered to reach them, making an exception if need be to the aforementioned cost-efficiency principle

The Council clarifies that Member States decide whether or not to deploy ITS applications and services on their territory. However, if ITS applications and services are deployed, the specifications adopted under this directive shall be respected. The Council also foresees that Member States shall make efforts to co-operate in respect of the aforementioned priority areas insofar no specifications have been adopted.

Specifications

The Commission proposal foresaw to apply the comitology procedure (regulatory procedure with scrutiny) for the adoption of specifications defining detailed provisions and procedures for the deployment of ITS across the Union. Further, these specifications should be based on certain principles laid down in Annex I and should contain at least the core elements set out in Annex II.

The European Parliament further specified that the Commission should define specifications for the obligatory deployment and use of the minimum level of ITS applications and services in four areas (see section on priority actions). The Commission should further define specifications for the necessary deployment and use of ITS beyond the minimum level of ITS applications and services in the case of Community co-financed Trans European Road Network (TERN) construction or maintenance. The specifications should also determine the conditions under which Member States might, in conjunction with the Commission, impose additional rules for the provision of such services throughout or in part of their territory. Before adopting specifications, the Commission should conduct an impact assessment comprising a comprehensive cost-benefit analysis for the implementing measures provided in the directive. The impact assessment should address issues of additional economic costs to be borne by the economic actors and parameters related to the economic cycle of the ITS.

The Council position at first reading develops the idea of the European Parliament to prioritize certain ITS applications and services reflected in the priority actions. For this purpose, the Commission shall aim to adopt specifications for the above priority actions. Further, at the latest 12 months after the adoption of the necessary specifications for a priority action, the Commission shall, where appropriate, and after having conducted an impact assessment accompanied by a cost-benefit-analysis, present a proposal to the EP and the Council on the deployment of that priority action. Further, the Council specifies that specifications may include functional, technical, organisational and service provisions. The Council conforms with the EP position that Member States, after notification to the Commission, may establish additional rules for the provision of ITS services on their territory. The Council foresees that specifications shall, where appropriate, be based on standards and that the Commission shall always conduct an impact assessment prior to the adoption of specifications. Lastly, the Council foresees that the Commission may adopt specifications through the delegated acts procedure in accordance with Article 290 of the Treaty of the Functioning of the European Union. The power of adopting specifications according to this procedure will end after a period of seven years following the entry into force of this directive. The EP or the Council may revoke the delegations of powers to adopt specifications at any time. The European Parliament or the Council may object to specifications within a period of two months from the date of notification. At the initiative of the EP or the Council this period may be extended by two months.

Standards and non-binding measures

The Commission proposal and the European Parliament did not make a reference to standards and non-binding measures.

The Council position at first reading makes reference to standards which may be developed in the priority areas and priority actions following the procedure laid down in Directive 98/34/EC. These standards should provide for interoperability, compatibility and continuity for the deployment and operational use of ITS applications and services. Further, the Council introduces an article on the adoption of guidelines and other non-binding measures by the Commission in order to facilitate Member States' co-operation relating to the priority areas.

Data protection

The Commission proposal made a general reference to existing Union legislation in the field of data protection and privacy.

The European Parliament specified the provisions on data protection and privacy by encouraging the use of anonymous data for the performance of the ITS application and/or service. Personal data should only be processed insofar as processing were necessary for the performance of the ITS application and/or service.

The Council position at first reading takes account of the EP position as well as the opinion of the European Data Protection Supervisor by strengthening the provisions on data protection and privacy.

Rules on liability

The Commission proposal did not foresee rules on liability.

The European Parliament considered liability issues as a necessary pre-condition for the swift development and deployment of ITS applications and services.

The Council position at first reading takes account of the EP position and makes a reference to relevant existing Union law and national legislation.

Principles for specifications and deployment of ITS

The Commission proposal established certain principles to be respected when selecting and deploying ITS applications and services.

The European Parliament strengthened and expanded the above mentioned principles by making a reference to the protection of vulnerable road users, seamless services across the Community and its external borders as well as to intermodality.

The Council position at first reading inspired by the EP position develops further the respective provisions by making reference to proportionality, interoperability, backward compatibility and respect existing national infrastructure and network characteristics, equality of access, quality of timing and positioning, and coherence.

9.   Other amendments adopted by the European Parliament

Further amendments not included in the Council first reading position concern:

| — | a reference to advanced applications and Community mechanisms for different transport modes such as for railway transport (ERTMS and TAF-TSI), open sea and inland waterways (LRITS, SafeSeaNet, VTMIS, RIS), air transport (SESAR) and land transport, for example, livestock transport (amendment 2); |
| --- | --- |

—

a reference to advanced applications and Community mechanisms for different transport modes such as for railway transport (ERTMS and TAF-TSI), open sea and inland waterways (LRITS, SafeSeaNet, VTMIS, RIS), air transport (SESAR) and land transport, for example, livestock transport (amendment 2);

| — | a reference to Dedicated Short Range Communication (DSRC) (amendments 5, 16 and 53); |
| --- | --- |

—

a reference to Dedicated Short Range Communication (DSRC) (amendments 5, 16 and 53);

| — | a reference to travellers, vehicles and infrastructure and their interaction in the field of road transport, including urban transport, in the article ‘subject matter and scope’ (amendment 7); |
| --- | --- |

—

a reference to travellers, vehicles and infrastructure and their interaction in the field of road transport, including urban transport, in the article ‘subject matter and scope’ (amendment 7);

| — | the establishment and definition of a minimum level of ITS applications and services (amendments 12, 20 and 21); |
| --- | --- |

—

the establishment and definition of a minimum level of ITS applications and services (amendments 12, 20 and 21);

| — | additional provisions concerning ‘Type-approval of road-infrastructure related ITS equipment and software’ (amendments 27, 28, 29, 30 and 31); |
| --- | --- |

—

additional provisions concerning ‘Type-approval of road-infrastructure related ITS equipment and software’ (amendments 27, 28, 29, 30 and 31);

| — | a transposition period of 12 months following the entry into force of this directive (amendment 49); |
| --- | --- |

—

a transposition period of 12 months following the entry into force of this directive (amendment 49);

| — | the obligation to Member States to draw up a correlation table between adopted national provisions and this directive (amendment 49). |
| --- | --- |

—

the obligation to Member States to draw up a correlation table between adopted national provisions and this directive (amendment 49).

IV.   CONCLUSION

In establishing its position at first reading, the Council has taken full account of the proposal of the Commission and the European Parliament’s opinion at first reading. With respect to the amendments proposed by the European Parliament, the Council observes that a considerable number of amendments have – in spirit, partially or fully – already been included in its first reading position.

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(1)  Intelligent Transport Systems

(2)  Not yet published in the Official Journal.

(3)  doc. 12479/09

(4)  doc. 10954/06

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| 27.7.2010 | EN | Official Journal of the European Union | CE 203/19 |
| --- | --- | --- | --- |

27.7.2010

EN

Official Journal of the European Union

CE 203/19

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POSITION (EU) No 12/2010 OF THE COUNCIL AT FIRST READING

with a view to the adoption of a directive of the European Parliament and of the Council on the protection of animals used for scientific purposes

Adopted by the Council on 3 June 2010

(Text with EEA relevance)

(2010/C 203 E/02)

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 114 thereof,

Having regard to the proposal from the European Commission,

Having regard to the opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

| (1) | On 24 November 1986 the Council adopted Directive 86/609/EEC (3) in order to eliminate disparities between laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Since the adoption of that Directive, further disparities between Member States have emerged. Certain Member States have adopted national implementing measures that ensure a high level of protection of animals used for scientific purposes, while others only apply the minimum requirements laid down in Directive 86/609/EEC. These disparities are liable to constitute barriers to trade in products and substances the development of which involves experiments on animals. Accordingly, this Directive should provide for more detailed rules in order to reduce such disparities by approximating the rules applicable in that area and to ensure a proper functioning of the internal market. |
| --- | --- |

(1)

On 24 November 1986 the Council adopted Directive 86/609/EEC (3) in order to eliminate disparities between laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Since the adoption of that Directive, further disparities between Member States have emerged. Certain Member States have adopted national implementing measures that ensure a high level of protection of animals used for scientific purposes, while others only apply the minimum requirements laid down in Directive 86/609/EEC. These disparities are liable to constitute barriers to trade in products and substances the development of which involves experiments on animals. Accordingly, this Directive should provide for more detailed rules in order to reduce such disparities by approximating the rules applicable in that area and to ensure a proper functioning of the internal market.

| (2) | Animal welfare is a value of the Union that is enshrined in Article 13 of the Treaty. |
| --- | --- |

(2)

Animal welfare is a value of the Union that is enshrined in Article 13 of the Treaty.

| (3) | On 23 March 1998 the Council adopted Decision 1999/575/EC concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes (4). By becoming party to that Convention, the Community acknowledged the importance of the protection and welfare of animals used for scientific purposes at international level. |
| --- | --- |

(3)

On 23 March 1998 the Council adopted Decision 1999/575/EC concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes (4). By becoming party to that Convention, the Community acknowledged the importance of the protection and welfare of animals used for scientific purposes at international level.

| (4) | The European Parliament in its resolution of 5 December 2002 on Directive 86/609/EEC called for the Commission to come forward with a proposal for a revision of that Directive with more stringent and transparent measures in the area of animal experimentation. |
| --- | --- |

(4)

The European Parliament in its resolution of 5 December 2002 on Directive 86/609/EEC called for the Commission to come forward with a proposal for a revision of that Directive with more stringent and transparent measures in the area of animal experimentation.

| (5) | On 15 June 2006, the Fourth Multilateral Consultation of Parties to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes adopted a revised Appendix A to that Convention, which set out guidelines for the accommodation and care of experimental animals. Commission Recommendation 2007/526/EC of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (5) incorporated those guidelines. |
| --- | --- |

(5)

On 15 June 2006, the Fourth Multilateral Consultation of Parties to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes adopted a revised Appendix A to that Convention, which set out guidelines for the accommodation and care of experimental animals. Commission Recommendation 2007/526/EC of 18 June 2007 on guidelines for the accommodation and care of animals used for experimental and other scientific purposes (5) incorporated those guidelines.

| (6) | New scientific knowledge is available in respect of factors influencing animal welfare as well as the capacity of animals to sense and express pain, suffering, distress and lasting harm. It is therefore necessary to improve the welfare of animals used in scientific procedures by raising the minimum standards for their protection in line with the latest scientific developments. |
| --- | --- |

(6)

New scientific knowledge is available in respect of factors influencing animal welfare as well as the capacity of animals to sense and express pain, suffering, distress and lasting harm. It is therefore necessary to improve the welfare of animals used in scientific procedures by raising the minimum standards for their protection in line with the latest scientific developments.

| (7) | Attitudes towards animals also depend on national perceptions, and there is a demand in certain Member States to maintain more extensive animal-welfare rules than those agreed upon at the level of the Union. In the interests of the animals, and provided it does not affect the functioning of the internal market, it is appropriate to allow the Member States certain flexibility to maintain national rules aimed at more extensive protection of animals in so far as they are compatible with the Treaty. |
| --- | --- |

(7)

Attitudes towards animals also depend on national perceptions, and there is a demand in certain Member States to maintain more extensive animal-welfare rules than those agreed upon at the level of the Union. In the interests of the animals, and provided it does not affect the functioning of the internal market, it is appropriate to allow the Member States certain flexibility to maintain national rules aimed at more extensive protection of animals in so far as they are compatible with the Treaty.

| (8) | In addition to vertebrate animals including cyclostomes, cephalopods should also be included in the scope of this Directive, as there is scientific evidence of their ability to experience pain, suffering, distress and lasting harm. |
| --- | --- |

(8)

In addition to vertebrate animals including cyclostomes, cephalopods should also be included in the scope of this Directive, as there is scientific evidence of their ability to experience pain, suffering, distress and lasting harm.

| (9) | This Directive should also cover foetal forms of mammals, as there is scientific evidence showing that such forms in the last third of the period of their development are at an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development. Scientific evidence also shows that procedures carried out on embryonic and foetal forms at an earlier stage of development could result in pain, suffering, distress or lasting harm, should the developmental forms be allowed to live beyond the first two thirds of their development. |
| --- | --- |

(9)

This Directive should also cover foetal forms of mammals, as there is scientific evidence showing that such forms in the last third of the period of their development are at an increased risk of experiencing pain, suffering and distress, which may also affect negatively their subsequent development. Scientific evidence also shows that procedures carried out on embryonic and foetal forms at an earlier stage of development could result in pain, suffering, distress or lasting harm, should the developmental forms be allowed to live beyond the first two thirds of their development.

| (10) | While it is desirable to replace the use of live animals in procedures by other methods not entailing the use of live animals, the use of live animals continues to be necessary to protect human and animal health and the environment. However, this Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches. It also seeks to ensure a high level of protection for animals that still need to be used in procedures. This Directive should be reviewed regularly in light of evolving science and animal-protection measures. |
| --- | --- |

(10)

While it is desirable to replace the use of live animals in procedures by other methods not entailing the use of live animals, the use of live animals continues to be necessary to protect human and animal health and the environment. However, this Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so. To that end, it seeks to facilitate and promote the advancement of alternative approaches. It also seeks to ensure a high level of protection for animals that still need to be used in procedures. This Directive should be reviewed regularly in light of evolving science and animal-protection measures.

| (11) | The care and use of live animals for scientific purposes is governed by internationally established principles of replacement, reduction and refinement. To ensure that the way in which animals are bred, cared for and used in procedures within the Union is in line with that of the other international and national standards applicable outside the Union, the principles of replacement, reduction and refinement should be considered systematically when implementing this Directive. When choosing methods, the principles of replacement, reduction and refinement should be implemented through a strict hierarchy of the requirement to use alternative methods. Where no alternative method is recognised by the legislation of the Union, the numbers of animals used may be reduced by resorting to other methods and by implementing testing strategies, such as the use of in vitro and other methods that would reduce and refine the use of animals. |
| --- | --- |

(11)

The care and use of live animals for scientific purposes is governed by internationally established principles of replacement, reduction and refinement. To ensure that the way in which animals are bred, cared for and used in procedures within the Union is in line with that of the other international and national standards applicable outside the Union, the principles of replacement, reduction and refinement should be considered systematically when implementing this Directive. When choosing methods, the principles of replacement, reduction and refinement should be implemented through a strict hierarchy of the requirement to use alternative methods. Where no alternative method is recognised by the legislation of the Union, the numbers of animals used may be reduced by resorting to other methods and by implementing testing strategies, such as the use of in vitro and other methods that would reduce and refine the use of animals.

| (12) | Animals have an intrinsic value which must be respected. There are also the ethical concerns of the general public as regards the use of animals in procedures. Therefore, animals should always be treated as sentient creatures and their use in procedures should be restricted to areas which may ultimately benefit human or animal health, or the environment. The use of animals for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable. Use of animals for scientific procedures in other areas under the competence of the Union should be prohibited. |
| --- | --- |

(12)

Animals have an intrinsic value which must be respected. There are also the ethical concerns of the general public as regards the use of animals in procedures. Therefore, animals should always be treated as sentient creatures and their use in procedures should be restricted to areas which may ultimately benefit human or animal health, or the environment. The use of animals for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable. Use of animals for scientific procedures in other areas under the competence of the Union should be prohibited.

| (13) | The choice of methods and the species to be used have a direct impact on both - the numbers of animals used and their welfare. The choice of methods should therefore ensure the selection of the method that is able to provide the most satisfactory results and is likely to cause the minimum pain, suffering or distress. The methods selected should use the minimum number of animals that would provide reliable results and require the use of species with the lowest capacity to experience pain, suffering, distress or lasting harm that are optimal for extrapolation into target species. |
| --- | --- |

(13)

The choice of methods and the species to be used have a direct impact on both - the numbers of animals used and their welfare. The choice of methods should therefore ensure the selection of the method that is able to provide the most satisfactory results and is likely to cause the minimum pain, suffering or distress. The methods selected should use the minimum number of animals that would provide reliable results and require the use of species with the lowest capacity to experience pain, suffering, distress or lasting harm that are optimal for extrapolation into target species.

| (14) | The methods selected should avoid, as far as possible, death as an end-point due to the severe suffering experienced during the period before death. Where possible, it should be substituted by more humane end-points using clinical signs that determine the impending death, thereby allowing the animal to be killed without any further suffering. |
| --- | --- |

(14)

The methods selected should avoid, as far as possible, death as an end-point due to the severe suffering experienced during the period before death. Where possible, it should be substituted by more humane end-points using clinical signs that determine the impending death, thereby allowing the animal to be killed without any further suffering.

| (15) | The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by a competent person using a method that is appropriate to the species. |
| --- | --- |

(15)

The use of inappropriate methods for killing an animal can cause significant pain, distress and suffering to the animal. The level of competence of the person carrying out this operation is equally important. Animals should therefore be killed only by a competent person using a method that is appropriate to the species.

| (16) | It is necessary to ensure that the use of animals in procedures does not pose a threat to biodiversity. Therefore, the use of endangered species in procedures should be limited to a strict minimum. |
| --- | --- |

(16)

It is necessary to ensure that the use of animals in procedures does not pose a threat to biodiversity. Therefore, the use of endangered species in procedures should be limited to a strict minimum.

| (17) | Having regard to the present state of scientific knowledge, the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of non-human primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates is of the greatest concern to the public. Therefore the use of non-human primates should be permitted only in those biomedical areas essential for the benefit of human beings, for which no other alternative replacement methods are yet available. Their use should be permitted only for basic research, the preservation of the respective non-human primate species or when the work, including xenotransplantation, is carried out in relation to potentially life-threatening conditions in humans or in relation to cases having a substantial impact on a person’s day-to-day functioning, i.e. debilitating conditions. |
| --- | --- |

(17)

Having regard to the present state of scientific knowledge, the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of non-human primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates is of the greatest concern to the public. Therefore the use of non-human primates should be permitted only in those biomedical areas essential for the benefit of human beings, for which no other alternative replacement methods are yet available. Their use should be permitted only for basic research, the preservation of the respective non-human primate species or when the work, including xenotransplantation, is carried out in relation to potentially life-threatening conditions in humans or in relation to cases having a substantial impact on a person’s day-to-day functioning, i.e. debilitating conditions.

| (18) | The use of great apes, as the closest species to human beings with the most advanced social and behavioural skills, should be permitted only for the purposes of research aimed at the preservation of those species and where action in relation to a life-threatening, debilitating condition endangering human beings is warranted, and no other species or alternative method would suffice in order to achieve the aims of the procedure. The Member State claiming such a need should provide information necessary for the Commission to take a decision. |
| --- | --- |

(18)

The use of great apes, as the closest species to human beings with the most advanced social and behavioural skills, should be permitted only for the purposes of research aimed at the preservation of those species and where action in relation to a life-threatening, debilitating condition endangering human beings is warranted, and no other species or alternative method would suffice in order to achieve the aims of the procedure. The Member State claiming such a need should provide information necessary for the Commission to take a decision.

| (19) | The capture of non-human primates from the wild is highly stressful for the animals concerned and carries an elevated risk of injury and suffering during capture and transport. In order to end the capturing of animals from the wild for breeding purposes, only animals that are the offspring of an animal which has been bred in captivity, or that are sourced from self-sustaining colonies, should be used in procedures after an appropriate transition period. A feasibility study should be carried out to that effect and the transition period adopted if necessary. The feasibility of moving towards sourcing non-human primates only from self-sustaining colonies as an ultimate goal should also be examined. |
| --- | --- |

(19)

The capture of non-human primates from the wild is highly stressful for the animals concerned and carries an elevated risk of injury and suffering during capture and transport. In order to end the capturing of animals from the wild for breeding purposes, only animals that are the offspring of an animal which has been bred in captivity, or that are sourced from self-sustaining colonies, should be used in procedures after an appropriate transition period. A feasibility study should be carried out to that effect and the transition period adopted if necessary. The feasibility of moving towards sourcing non-human primates only from self-sustaining colonies as an ultimate goal should also be examined.

| (20) | There is a need for certain species of vertebrate animals used in procedures to be bred specifically for that purpose so that their genetic, biological and behavioural background is well-known to persons undertaking the procedures. Such knowledge both increases the scientific quality and reliability of the results and decreases the variability, ultimately resulting in fewer procedures and reduced animal use. Furthermore, for reasons of animal welfare and conservation, the use of animals taken from the wild in procedures should be limited to cases where the purpose of the procedures cannot be achieved using animals bred specifically for use in procedures. |
| --- | --- |

(20)

There is a need for certain species of vertebrate animals used in procedures to be bred specifically for that purpose so that their genetic, biological and behavioural background is well-known to persons undertaking the procedures. Such knowledge both increases the scientific quality and reliability of the results and decreases the variability, ultimately resulting in fewer procedures and reduced animal use. Furthermore, for reasons of animal welfare and conservation, the use of animals taken from the wild in procedures should be limited to cases where the purpose of the procedures cannot be achieved using animals bred specifically for use in procedures.

| (21) | Since the background of stray and feral animals of domestic species is not known, and since capture and placement into establishments increases distress for such animals, they should not, as a general rule, be used in procedures. |
| --- | --- |

(21)

Since the background of stray and feral animals of domestic species is not known, and since capture and placement into establishments increases distress for such animals, they should not, as a general rule, be used in procedures.

| (22) | To enhance transparency, facilitate the project authorisation, and provide tools for monitoring compliance, a severity classification of procedures should be introduced on the basis of estimated levels of pain, suffering, distress and lasting harm that is inflicted on the animals. |
| --- | --- |

(22)

To enhance transparency, facilitate the project authorisation, and provide tools for monitoring compliance, a severity classification of procedures should be introduced on the basis of estimated levels of pain, suffering, distress and lasting harm that is inflicted on the animals.

| (23) | From an ethical standpoint, there should be an upper limit of pain, suffering and distress above which animals should not be subjected in scientific procedures. To that end, the performance of procedures that result in severe pain, suffering or distress, which is likely to be long-lasting and cannot be ameliorated, should be prohibited. |
| --- | --- |

(23)

From an ethical standpoint, there should be an upper limit of pain, suffering and distress above which animals should not be subjected in scientific procedures. To that end, the performance of procedures that result in severe pain, suffering or distress, which is likely to be long-lasting and cannot be ameliorated, should be prohibited.

| (24) | When developing a common format for reporting purposes, the actual severity of the pain, suffering, distress or lasting harm experienced by the animal should be taken into account rather than the predicted severity at the time of the project evaluation. |
| --- | --- |

(24)

When developing a common format for reporting purposes, the actual severity of the pain, suffering, distress or lasting harm experienced by the animal should be taken into account rather than the predicted severity at the time of the project evaluation.

| (25) | The number of animals used in procedures could be reduced by performing procedures on animals more than once, where this does not detract from the scientific objective or result in poor animal welfare. However, the benefit of reusing animals should be balanced against any adverse effects on their welfare, taking into account the lifetime experience of the individual animal. As a result of this potential conflict, the reuse of animals should be considered on a case-by-case basis. |
| --- | --- |

(25)

The number of animals used in procedures could be reduced by performing procedures on animals more than once, where this does not detract from the scientific objective or result in poor animal welfare. However, the benefit of reusing animals should be balanced against any adverse effects on their welfare, taking into account the lifetime experience of the individual animal. As a result of this potential conflict, the reuse of animals should be considered on a case-by-case basis.

| (26) | At the end of the procedure, the most appropriate decision should be taken as regards the future of the animal on the basis of animal welfare and potential risks to the environment. The animals whose welfare would be compromised should be killed. In some cases, animals should be returned to a suitable habitat or husbandry system or animals such as dogs and cats should be allowed to be rehomed in families as there is a high level of public concern as to the fate of such animals. Should Member States allow rehoming, it is essential that the breeder, supplier or user has a scheme in place to provide appropriate socialisation to those animals in order to ensure successful rehoming as well as to avoid unnecessary distress to the animals and to guarantee public safety. |
| --- | --- |

(26)

At the end of the procedure, the most appropriate decision should be taken as regards the future of the animal on the basis of animal welfare and potential risks to the environment. The animals whose welfare would be compromised should be killed. In some cases, animals should be returned to a suitable habitat or husbandry system or animals such as dogs and cats should be allowed to be rehomed in families as there is a high level of public concern as to the fate of such animals. Should Member States allow rehoming, it is essential that the breeder, supplier or user has a scheme in place to provide appropriate socialisation to those animals in order to ensure successful rehoming as well as to avoid unnecessary distress to the animals and to guarantee public safety.

| (27) | Animal tissue and organs are used for the development of in vitro methods. To promote the principle of reduction, Member States should, where appropriate, facilitate the establishment of programmes for sharing the organs and tissue of animals that are killed. |
| --- | --- |

(27)

Animal tissue and organs are used for the development of in vitro methods. To promote the principle of reduction, Member States should, where appropriate, facilitate the establishment of programmes for sharing the organs and tissue of animals that are killed.

| (28) | The welfare of the animals used in procedures is highly dependent on the quality and professional competence of the personnel supervising procedures, as well as of those performing procedures or supervising those taking care of the animals on a daily basis. Member States should ensure through authorisation or by other means that staff are adequately educated, trained and competent. Furthermore, it is important that staff are supervised until they have obtained and demonstrated the requisite competence. Non-binding guidelines at the level of the Union concerning educational requirements would, in the long run, promote the free movement of personnel. |
| --- | --- |

(28)

The welfare of the animals used in procedures is highly dependent on the quality and professional competence of the personnel supervising procedures, as well as of those performing procedures or supervising those taking care of the animals on a daily basis. Member States should ensure through authorisation or by other means that staff are adequately educated, trained and competent. Furthermore, it is important that staff are supervised until they have obtained and demonstrated the requisite competence. Non-binding guidelines at the level of the Union concerning educational requirements would, in the long run, promote the free movement of personnel.

| (29) | The establishments of breeders, suppliers and users should have adequate installations and equipment in place to meet the accommodation requirements of the animal species concerned and to allow the procedures to be performed efficiently and with the least distress to the animals. The breeders, suppliers and users should operate only if they are authorised by the competent authorities. |
| --- | --- |

(29)

The establishments of breeders, suppliers and users should have adequate installations and equipment in place to meet the accommodation requirements of the animal species concerned and to allow the procedures to be performed efficiently and with the least distress to the animals. The breeders, suppliers and users should operate only if they are authorised by the competent authorities.

| (30) | To ensure the ongoing monitoring of animal-welfare needs, appropriate veterinary care should be available at all times and a staff member should be made responsible for the care and welfare of animals in each establishment. |
| --- | --- |

(30)

To ensure the ongoing monitoring of animal-welfare needs, appropriate veterinary care should be available at all times and a staff member should be made responsible for the care and welfare of animals in each establishment.

| (31) | Animal-welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Breeders, suppliers and users should therefore have an animal-welfare body in place with the primary task of focusing on giving advice on animal-welfare issues. The body should also follow the development and outcome of projects at establishment level, foster a climate of care and provide tools for the practical application and timely implementation of recent technical and scientific developments in relation to the principles of replacement, reduction and refinement, in order to enhance the life-time experience of the animals. The advice given by the animal-welfare body should be properly documented and open to scrutiny during inspections. |
| --- | --- |

(31)

Animal-welfare considerations should be given the highest priority in the context of animal keeping, breeding and use. Breeders, suppliers and users should therefore have an animal-welfare body in place with the primary task of focusing on giving advice on animal-welfare issues. The body should also follow the development and outcome of projects at establishment level, foster a climate of care and provide tools for the practical application and timely implementation of recent technical and scientific developments in relation to the principles of replacement, reduction and refinement, in order to enhance the life-time experience of the animals. The advice given by the animal-welfare body should be properly documented and open to scrutiny during inspections.

| (32) | In order to enable competent authorities to monitor compliance with this Directive, each breeder, supplier and user should maintain accurate records of the numbers of animals, their origins and fate. |
| --- | --- |

(32)

In order to enable competent authorities to monitor compliance with this Directive, each breeder, supplier and user should maintain accurate records of the numbers of animals, their origins and fate.

| (33) | Non-human primates, dogs and cats should have a personal history file from birth covering their lifetimes in order to be able to receive the care, accommodation and treatment that meet their individual needs and characteristics. |
| --- | --- |

(33)

Non-human primates, dogs and cats should have a personal history file from birth covering their lifetimes in order to be able to receive the care, accommodation and treatment that meet their individual needs and characteristics.

| (34) | The accommodation and care of animals should be based on the specific needs and characteristics of each species. |
| --- | --- |

(34)

The accommodation and care of animals should be based on the specific needs and characteristics of each species.

| (35) | There are differences in the requirements for the accommodation and care of animals between Member States, which contribute to the distortion of the internal market. Furthermore, some of those requirements no longer reflect the most recent knowledge on the impacts of accommodation and care conditions on both the animal welfare and the scientific results of procedures. It is therefore necessary to establish in this Directive harmonised requirements for accommodation and care. These requirements should be updated on the basis of scientific and technical development. |
| --- | --- |

(35)

There are differences in the requirements for the accommodation and care of animals between Member States, which contribute to the distortion of the internal market. Furthermore, some of those requirements no longer reflect the most recent knowledge on the impacts of accommodation and care conditions on both the animal welfare and the scientific results of procedures. It is therefore necessary to establish in this Directive harmonised requirements for accommodation and care. These requirements should be updated on the basis of scientific and technical development.

| (36) | To monitor compliance with this Directive, Member States should carry out regular inspections of breeders, suppliers and users on a risk basis. To ensure public confidence and promote transparency, an appropriate proportion of the inspections should be carried out without prior warning. |
| --- | --- |

(36)

To monitor compliance with this Directive, Member States should carry out regular inspections of breeders, suppliers and users on a risk basis. To ensure public confidence and promote transparency, an appropriate proportion of the inspections should be carried out without prior warning.

| (37) | To assist the Member States in the enforcement of this Directive and on the basis of the findings in the reports on the operation of the national inspections, the Commission should, when there is reason for concern, carry out controls of the national inspection systems. Member States should address any weaknesses identified in the findings of these controls. |
| --- | --- |

(37)

To assist the Member States in the enforcement of this Directive and on the basis of the findings in the reports on the operation of the national inspections, the Commission should, when there is reason for concern, carry out controls of the national inspection systems. Member States should address any weaknesses identified in the findings of these controls.

| (38) | Comprehensive project evaluation, taking into account ethical considerations in the use of animals, forms the core of project authorisation and should ensure the implementation of principles of replacement, reduction and refinement in those projects. |
| --- | --- |

(38)

Comprehensive project evaluation, taking into account ethical considerations in the use of animals, forms the core of project authorisation and should ensure the implementation of principles of replacement, reduction and refinement in those projects.

| (39) | It is also essential, both on moral and scientific grounds, to ensure that each use of an animal is carefully evaluated as to the scientific or educational validity, usefulness and relevance of the expected result of that use. The likely harm to the animal should be balanced against the expected benefits of the project. Therefore, an impartial project evaluation independent of those involved in the study should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of a project evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge. |
| --- | --- |

(39)

It is also essential, both on moral and scientific grounds, to ensure that each use of an animal is carefully evaluated as to the scientific or educational validity, usefulness and relevance of the expected result of that use. The likely harm to the animal should be balanced against the expected benefits of the project. Therefore, an impartial project evaluation independent of those involved in the study should be carried out as part of the authorisation process of projects involving the use of live animals. Effective implementation of a project evaluation should also allow for an appropriate assessment of the use of any new scientific experimental techniques as they emerge.

| (40) | Due to the nature of the project, the type of species used and the likelihood of achieving the desired objectives of the project, it might be necessary to carry out a retrospective assessment. Since projects may vary significantly in terms of complexity, length, and the time period for obtaining the results, it is necessary that the decision on retrospective assessment should be made taking those aspects fully into account. |
| --- | --- |

(40)

Due to the nature of the project, the type of species used and the likelihood of achieving the desired objectives of the project, it might be necessary to carry out a retrospective assessment. Since projects may vary significantly in terms of complexity, length, and the time period for obtaining the results, it is necessary that the decision on retrospective assessment should be made taking those aspects fully into account.

| (41) | To ensure that the public is informed, it is important that objective information concerning projects using live animals is made publicly available. This should not violate proprietary rights or expose confidential information. Therefore, users should provide anonymous non-technical summaries of those projects, which Member States should publish. The published details should not breach the anonymity of the users. |
| --- | --- |

(41)

To ensure that the public is informed, it is important that objective information concerning projects using live animals is made publicly available. This should not violate proprietary rights or expose confidential information. Therefore, users should provide anonymous non-technical summaries of those projects, which Member States should publish. The published details should not breach the anonymity of the users.

| (42) | To manage risks to human and animal health and the environment, the legislation of the Union provides that substances and products can be marketed only after appropriate safety and efficacy data have been submitted. Some of those requirements can be fulfilled only by resorting to animal testing, hereinafter referred to as ‘regulatory testing’. It is necessary to introduce specific measures in order to increase the use of alternative approaches and to eliminate unnecessary duplication of regulatory testing. For that purpose Member States should recognise the validity of test data produced using test methods provided for under the legislation of the Union. |
| --- | --- |

(42)

To manage risks to human and animal health and the environment, the legislation of the Union provides that substances and products can be marketed only after appropriate safety and efficacy data have been submitted. Some of those requirements can be fulfilled only by resorting to animal testing, hereinafter referred to as ‘regulatory testing’. It is necessary to introduce specific measures in order to increase the use of alternative approaches and to eliminate unnecessary duplication of regulatory testing. For that purpose Member States should recognise the validity of test data produced using test methods provided for under the legislation of the Union.

| (43) | To reduce the administrative workload and enhance the competitiveness of research and industry in the Union, it should be possible to authorise multiple generic projects when carried out using established methods for testing, diagnostic or production purposes under one group authorisation, albeit without exempting any of these procedures from the project evaluation. |
| --- | --- |

(43)

To reduce the administrative workload and enhance the competitiveness of research and industry in the Union, it should be possible to authorise multiple generic projects when carried out using established methods for testing, diagnostic or production purposes under one group authorisation, albeit without exempting any of these procedures from the project evaluation.

| (44) | To ensure effective examination of authorisation applications and to enhance the competitiveness of research and industry in the Union, a time-limit should be set for the competent authorities to evaluate project proposals and take decisions on the authorisation of such projects. In order not to compromise the quality of the project evaluation, additional time might be required for more complex project proposals due to the number of disciplines involved, the novel characteristics and more complex techniques of the proposed project. However, the extension of deadlines for project evaluation should remain the exception. |
| --- | --- |

(44)

To ensure effective examination of authorisation applications and to enhance the competitiveness of research and industry in the Union, a time-limit should be set for the competent authorities to evaluate project proposals and take decisions on the authorisation of such projects. In order not to compromise the quality of the project evaluation, additional time might be required for more complex project proposals due to the number of disciplines involved, the novel characteristics and more complex techniques of the proposed project. However, the extension of deadlines for project evaluation should remain the exception.

| (45) | Given the routine or repetitive nature of certain procedures, it is appropriate to provide for a regulatory option whereby the Member States could introduce a simplified administrative procedure for the evaluation of projects containing such procedures, provided certain requirements laid down in this Directive are complied with. |
| --- | --- |

(45)

Given the routine or repetitive nature of certain procedures, it is appropriate to provide for a regulatory option whereby the Member States could introduce a simplified administrative procedure for the evaluation of projects containing such procedures, provided certain requirements laid down in this Directive are complied with.

| (46) | The availability of alternative methods is highly dependent on the progress of the research into the development of alternatives. The Community Framework Programmes for Research and Technological Development provided increasing funding for projects which aim to replace, reduce and refine the use of animals in procedures. In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches. |
| --- | --- |

(46)

The availability of alternative methods is highly dependent on the progress of the research into the development of alternatives. The Community Framework Programmes for Research and Technological Development provided increasing funding for projects which aim to replace, reduce and refine the use of animals in procedures. In order to increase competitiveness of research and industry in the Union and to replace, reduce and refine the use of animals in procedures, the Commission and the Member States should contribute through research and by other means to the development and validation of alternative approaches.

| (47) | The European Centre for the Validation of Alternative Methods, a policy action within the Joint Research Centre of the Commission, has coordinated the validation of alternative approaches in the Union since 1991. However, there is an increasing need for new methods to be developed and proposed for validation, which requires a reference laboratory of the Union for the validation of alternative methods to be established formally. This laboratory should be referred to as the European Centre for the Validation of Alternative Methods (ECVAM). It is necessary for the Commission to cooperate with the Member States when setting priorities for validation studies. The Member States should assist the Commission in identifying and nominating suitable laboratories to carry out such validation studies. For validation studies that are similar to previously validated methods and in respect of which a validation represents a significant competitive advantage, ECVAM should be able to collect charges from those who submit their methods for validation. Such charges should not be prohibitive of healthy competition in the testing industry. |
| --- | --- |

(47)

The European Centre for the Validation of Alternative Methods, a policy action within the Joint Research Centre of the Commission, has coordinated the validation of alternative approaches in the Union since 1991. However, there is an increasing need for new methods to be developed and proposed for validation, which requires a reference laboratory of the Union for the validation of alternative methods to be established formally. This laboratory should be referred to as the European Centre for the Validation of Alternative Methods (ECVAM). It is necessary for the Commission to cooperate with the Member States when setting priorities for validation studies. The Member States should assist the Commission in identifying and nominating suitable laboratories to carry out such validation studies. For validation studies that are similar to previously validated methods and in respect of which a validation represents a significant competitive advantage, ECVAM should be able to collect charges from those who submit their methods for validation. Such charges should not be prohibitive of healthy competition in the testing industry.

| (48) | There is a need to ensure a coherent approach to project evaluation and review strategies at national level. Member States should establish national committees for the protection of animals used for scientific purposes to give advice to the competent authorities and animal-welfare bodies in order to promote the principles of replacement, reduction and refinement. A network of national committees should play a role in the exchange of best practice at the level of the Union. |
| --- | --- |

(48)

There is a need to ensure a coherent approach to project evaluation and review strategies at national level. Member States should establish national committees for the protection of animals used for scientific purposes to give advice to the competent authorities and animal-welfare bodies in order to promote the principles of replacement, reduction and refinement. A network of national committees should play a role in the exchange of best practice at the level of the Union.

| (49) | Technical and scientific advancements in biomedical research can be rapid, as can the increase in knowledge of factors influencing animal welfare. It is therefore necessary to provide for a review of this Directive. Such review should examine the possible replacement of the use of animals, and in particular non-human primates, as a matter of priority where it is possible, taking into account the advancement of science. The Commission should also conduct periodic thematic reviews concerning the replacement, reduction and refinement of the use of animals in procedures. |
| --- | --- |

(49)

Technical and scientific advancements in biomedical research can be rapid, as can the increase in knowledge of factors influencing animal welfare. It is therefore necessary to provide for a review of this Directive. Such review should examine the possible replacement of the use of animals, and in particular non-human primates, as a matter of priority where it is possible, taking into account the advancement of science. The Commission should also conduct periodic thematic reviews concerning the replacement, reduction and refinement of the use of animals in procedures.

| (50) | In order to ensure uniform conditions for implementation, implementing powers should be conferred on the Commission to adopt guidelines at the level of the Union on the requirements with regard to education, training and competence of breeders', suppliers' and users' staff, to adopt detailed rules regarding the Union Reference Laboratory, its duties and tasks and the charges it may collect, to establish a common format for submitting the information by Member States to the Commission on the implementation of this Directive, statistical information and other specific information, and for the application of safeguard clauses.
  According to Article 291 of the Treaty on the Functioning of the European Union, rules and general principles concerning mechanisms for the control by Member States of the Commission's exercise of implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable. |
| --- | --- |

(50)

In order to ensure uniform conditions for implementation, implementing powers should be conferred on the Commission to adopt guidelines at the level of the Union on the requirements with regard to education, training and competence of breeders', suppliers' and users' staff, to adopt detailed rules regarding the Union Reference Laboratory, its duties and tasks and the charges it may collect, to establish a common format for submitting the information by Member States to the Commission on the implementation of this Directive, statistical information and other specific information, and for the application of safeguard clauses.

According to Article 291 of the Treaty on the Functioning of the European Union, rules and general principles concerning mechanisms for the control by Member States of the Commission's exercise of implementing powers shall be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6) continues to apply, with the exception of the regulatory procedure with scrutiny, which is not applicable.

| (51) | The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty in respect of the following: modifications of the list of species falling under the obligation of being specifically bred for use in procedures; modifications of the care and accommodation standards; modifications of methods of killing, including their specifications; modifications of the elements to be used for the establishment by Member States of requirements with regard to education, training and competence of breeders', suppliers' and users' personnel; modifications of certain obligatory elements of the application for authorisation; modifications regarding the Union Reference Laboratory, its duties and tasks; as well as modifications of examples of different types of procedures assigned to each of the severity categories on the basis of factors related to the type of procedure. It is of particular importance that the Commission carry out appropriate consultation during its preparatory work, including at expert level. |
| --- | --- |

(51)

The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty in respect of the following: modifications of the list of species falling under the obligation of being specifically bred for use in procedures; modifications of the care and accommodation standards; modifications of methods of killing, including their specifications; modifications of the elements to be used for the establishment by Member States of requirements with regard to education, training and competence of breeders', suppliers' and users' personnel; modifications of certain obligatory elements of the application for authorisation; modifications regarding the Union Reference Laboratory, its duties and tasks; as well as modifications of examples of different types of procedures assigned to each of the severity categories on the basis of factors related to the type of procedure. It is of particular importance that the Commission carry out appropriate consultation during its preparatory work, including at expert level.

| (52) | Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive. |
| --- | --- |

(52)

Member States should lay down rules on penalties applicable to infringements of the provisions of this Directive and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

| (53) | Directive 86/609/EEC should therefore be repealed. Certain modifications introduced by this Directive have a direct impact on the application of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption (7). It is therefore appropriate to amend a provision of that Regulation accordingly. |
| --- | --- |

(53)

Directive 86/609/EEC should therefore be repealed. Certain modifications introduced by this Directive have a direct impact on the application of Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption (7). It is therefore appropriate to amend a provision of that Regulation accordingly.

| (54) | Benefits to animal welfare from applying project authorisation retrospectively, and the related administrative costs, can only be justified for long term ongoing projects. Therefore, it is necessary to include transitional measures for ongoing short and medium term projects to avoid the need for retrospective authorisation with only limited benefits. |
| --- | --- |

(54)

Benefits to animal welfare from applying project authorisation retrospectively, and the related administrative costs, can only be justified for long term ongoing projects. Therefore, it is necessary to include transitional measures for ongoing short and medium term projects to avoid the need for retrospective authorisation with only limited benefits.

| (55) | In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making, Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public. |
| --- | --- |

(55)

In accordance with paragraph 34 of the Interinstitutional Agreement on better law-making, Member States are encouraged to draw up, for themselves and in the interests of the Union, their own tables, which will, as far as possible, illustrate the correlation between this Directive and the transposition measures, and to make them public.

| (56) | Since the objective of this Directive, namely the harmonisation of legislation concerning the use of animals for scientific purposes, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at the level of the Union, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective, |
| --- | --- |

(56)

Since the objective of this Directive, namely the harmonisation of legislation concerning the use of animals for scientific purposes, cannot be sufficiently achieved by the Member States and can therefore, by reason of its scale and effects, be better achieved at the level of the Union, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

General provisions

Article 1

Subject matter and scope

1.   This Directive establishes measures for the protection of animals used for scientific or educational purposes.

To that end, it lays down rules on the following:

| (a) | the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures; |
| --- | --- |

(a)

the replacement and reduction of the use of animals in procedures and the refinement of the breeding, accommodation, care and use of animals in procedures;

| (b) | the origin, breeding, marking, care and accommodation and killing of animals; |
| --- | --- |

(b)

the origin, breeding, marking, care and accommodation and killing of animals;

| (c) | the operations of breeders, suppliers and users; |
| --- | --- |

(c)

the operations of breeders, suppliers and users;

| (d) | the evaluation and authorisation of projects involving the use of animals in procedures. |
| --- | --- |

(d)

the evaluation and authorisation of projects involving the use of animals in procedures.

2.   This Directive shall apply where animals are used or intended to be used in procedures, or bred specifically so that their organs or tissues may be used for scientific purposes.

This Directive shall apply until the animals referred to in the first subparagraph have been killed, rehomed or returned to a suitable habitat or husbandry system.

The elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia, analgesia or other methods shall not exclude the use of an animal in procedures from the scope of this Directive.

3.   This Directive shall apply to the following animals:

| (a) | live non-human vertebrate animals, including:






  (i) | independently feeding larval forms, and |
| --- | --- | --- |

(a)

live non-human vertebrate animals, including:

(i)

independently feeding larval forms, and

| (ii) | foetal forms of mammals as from the last third of their normal development; |
| --- | --- |

(ii)

foetal forms of mammals as from the last third of their normal development;

| (b) | live cephalopods. |
| --- | --- |

(b)

live cephalopods.

4.   This Directive shall apply to animals used in procedures, which are at an earlier stage of development than that referred to in point (a) of paragraph 3, if the animal is to be allowed to live beyond that stage of development and, as a result of the procedures performed, is likely to experience pain, suffering, distress or lasting harm after it has reached that stage of development.

5.   This Directive shall not apply to the following:

| (a) | non-experimental agricultural practices; |
| --- | --- |

(a)

non-experimental agricultural practices;

| (b) | non-experimental clinical veterinary practices; |
| --- | --- |

(b)

non-experimental clinical veterinary practices;

| (c) | veterinary clinical trials required for the marketing authorisation of a veterinary medicinal product; |
| --- | --- |

(c)

veterinary clinical trials required for the marketing authorisation of a veterinary medicinal product;

| (d) | practices undertaken for the purposes of recognised animal husbandry; |
| --- | --- |

(d)

practices undertaken for the purposes of recognised animal husbandry;

| (e) | practices undertaken for the primary purpose of identification of an animal; |
| --- | --- |

(e)

practices undertaken for the primary purpose of identification of an animal;

| (f) | practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. |
| --- | --- |

(f)

practices not likely to cause pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

6.   This Directive shall apply without prejudice to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (8).

Article 2

Stricter national measures

1.   Member States may, while observing the general rules laid down in the Treaty, maintain provisions in force on ... (9), aimed at ensuring more extensive protection of animals falling within the scope of this Directive than those contained in this Directive.

Before ... (10) Member States shall inform the Commission about such national provisions. The Commission shall bring them to the attention of other Member States.

2.   When acting pursuant to paragraph 1, a Member State shall not prohibit or impede the supply or use of animals bred or kept in another Member State in accordance with this Directive, nor shall it prohibit or impede the placing on the market of products developed with the use of such animals in accordance with this Directive.

Article 3

Definitions

For the purposes of this Directive the following definitions shall apply:

| (1) | ‘procedure’ means any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.
  This includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition, but excludes the killing of animals solely for the use of their organs or tissues; |
| --- | --- |

(1)

‘procedure’ means any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice.

This includes any course of action intended, or liable, to result in the birth or hatching of an animal or the creation and maintenance of a genetically modified animal line in any such condition, but excludes the killing of animals solely for the use of their organs or tissues;

| (2) | ‘project’ means a programme of work having a defined scientific objective and involving one or more procedures; |
| --- | --- |

(2)

‘project’ means a programme of work having a defined scientific objective and involving one or more procedures;

| (3) | ‘establishment’ means any installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities; |
| --- | --- |

(3)

‘establishment’ means any installation, building, group of buildings or other premises and may include a place that is not wholly enclosed or covered and mobile facilities;

| (4) | ‘breeder’ means any natural or legal person breeding animals referred to in Annex I with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, or breeding other animals primarily for those purposes, whether for profit or not; |
| --- | --- |

(4)

‘breeder’ means any natural or legal person breeding animals referred to in Annex I with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, or breeding other animals primarily for those purposes, whether for profit or not;

| (5) | ‘supplier’ means any natural or legal person, other than a breeder, supplying animals with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, whether for profit or not; |
| --- | --- |

(5)

‘supplier’ means any natural or legal person, other than a breeder, supplying animals with a view to their use in procedures or for the use of their tissue or organs for scientific purposes, whether for profit or not;

| (6) | ‘user’ means any natural or legal person using animals in procedures, whether for profit or not; |
| --- | --- |

(6)

‘user’ means any natural or legal person using animals in procedures, whether for profit or not;

| (7) | ‘competent authority’ means an authority or authorities or bodies designated by a Member State to carry out the obligations arising from this Directive. |
| --- | --- |

(7)

‘competent authority’ means an authority or authorities or bodies designated by a Member State to carry out the obligations arising from this Directive.

Article 4

Principle of replacement, reduction and refinement

1.   Member States shall ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure.

2.   Member States shall ensure that the number of animals used in projects is reduced to a minimum without compromising the objectives of the project.

3.   Member States shall ensure refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals.

4.   This Article shall, in the choice of methods, be implemented in accordance with Article 13.

Article 5

Purposes of procedures

Procedures may be carried out for the following purposes only:

| (a) | basic research; |
| --- | --- |

(a)

basic research;

| (b) | translational or applied research with any of the following aims:






  (i) | the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants; |
| --- | --- | --- |

(b)

translational or applied research with any of the following aims:

(i)

the avoidance, prevention, diagnosis or treatment of disease, ill-health or other abnormality or their effects in human beings, animals or plants;

| (ii) | the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants; or |
| --- | --- |

(ii)

the assessment, detection, regulation or modification of physiological conditions in human beings, animals or plants; or

| (iii) | the welfare of animals and the improvement of the production conditions for animals reared for agricultural purposes. |
| --- | --- |

(iii)

the welfare of animals and the improvement of the production conditions for animals reared for agricultural purposes.

| (c) | for any of the aims in point (b) in the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products; |
| --- | --- |

(c)

for any of the aims in point (b) in the development, manufacture or testing of the quality, effectiveness and safety of drugs, foodstuffs and feed-stuffs and other substances or products;

| (d) | protection of the natural environment in the interests of the health or welfare of human beings or animals; |
| --- | --- |

(d)

protection of the natural environment in the interests of the health or welfare of human beings or animals;

| (e) | research aimed at preservation of the species; |
| --- | --- |

(e)

research aimed at preservation of the species;

| (f) | higher education, or training for the acquisition, maintenance or improvement of vocational skills; |
| --- | --- |

(f)

higher education, or training for the acquisition, maintenance or improvement of vocational skills;

| (g) | forensic inquiries. |
| --- | --- |

(g)

forensic inquiries.

Article 6

Methods of killing

1.   Member States shall ensure that animals are killed with minimum pain, suffering and distress.

2.   Member States shall ensure that animals are killed in the establishment of a breeder, supplier or user, by a competent person.

However, in the case of a field study an animal may be killed by a competent person outside of an establishment.

3.   In relation to the animals covered by Annex IV, the appropriate method of killing as set out in that Annex shall be used.

4.   Competent authorities may grant exemptions from the requirement in paragraph 3:

| (a) | to allow the use of another method provided that, on the basis of scientific evidence, the method is considered to be at least as humane; or |
| --- | --- |

(a)

to allow the use of another method provided that, on the basis of scientific evidence, the method is considered to be at least as humane; or

| (b) | when, on the basis of scientific justification, the purpose of the procedure cannot be achieved by the use of a method of killing set out in Annex IV. |
| --- | --- |

(b)

when, on the basis of scientific justification, the purpose of the procedure cannot be achieved by the use of a method of killing set out in Annex IV.

5.   Paragraphs 2 and 3 shall not apply where an animal has to be killed in emergency circumstances for animal-welfare, public-health, public-security, animal-health or environmental reasons.

CHAPTER II

Provisions on the use of certain animals in procedures

Article 7

Endangered species

1.   Specimens of those endangered species listed in Annex A to Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (11), which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:

| (a) | the procedure has one of the purposes referred to in points (b)(i), (c) or (e) of Article 5 of this Directive; and |
| --- | --- |

(a)

the procedure has one of the purposes referred to in points (b)(i), (c) or (e) of Article 5 of this Directive; and

| (b) | there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than those listed in that Annex. |
| --- | --- |

(b)

there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than those listed in that Annex.

2.   Paragraph 1 shall not apply to any species of non-human primates.

Article 8

Non-human primates

1.   Subject to paragraph 2, specimens of non-human primates shall not be used in procedures, with the exception of those procedures meeting the following conditions:

| (a) | the procedure has one of the purposes referred to in






  (i) | points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or |
| --- | --- | --- |

(a)

the procedure has one of the purposes referred to in

(i)

points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or

| (ii) | points (a) or (e) of Article 5; |
| --- | --- |

(ii)

points (a) or (e) of Article 5;

and

| (b) | there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates. |
| --- | --- |

(b)

there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates.

A debilitating clinical condition for the purposes of this Directive means a reduction in a person's normal physical or psychological ability to function.

2.   Specimens of non-human primates listed in Annex A to Regulation (EC) No 338/97, which do not fall within the scope of Article 7(1) of that Regulation, shall not be used in procedures, with the exception of those procedures meeting the following conditions:

| (a) | the procedure has one of the purposes referred to in






  (i) | points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or |
| --- | --- | --- |

(a)

the procedure has one of the purposes referred to in

(i)

points (b)(i) or (c) of Article 5 of this Directive and is undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions in human beings; or

| (ii) | point (e) of Article 5; |
| --- | --- |

(ii)

point (e) of Article 5;

and

| (b) | there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates and by the use of species not listed in that Annex. |
| --- | --- |

(b)

there is scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of species other than non-human primates and by the use of species not listed in that Annex.

3.   Notwithstanding paragraphs 1 and 2, great apes shall not be used in procedures, subject to the use of the safeguard clause in Article 55(2).

Article 9

Animals taken from the wild

1.   Animals taken from the wild shall not be used in procedures.

2.   Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification to the effect that the purpose of the procedure cannot be achieved by the use of an animal which has been bred for use in procedures.

3.   The capture of animals in the wild shall be carried out only by competent persons using methods which do not cause the animals avoidable pain, suffering, distress or lasting harm.

Any animal found, at or after capture, to be injured or in poor health shall be examined by a veterinarian or another competent person and action shall be taken to minimise the suffering of the animal. Competent authorities may grant exemptions from the requirement of taking action to minimise the suffering of the animal if there is scientific justification.

Article 10

Animals bred for use in procedures

1.   Member States shall ensure that animals belonging to the species listed in Annex I may only be used in procedures where those animals have been bred for use in procedures.

However, from the dates set out in Annex II, Member States shall ensure that non-human primates listed therein may be used in procedures only where they are the offspring of non-human primates which have been bred in captivity or where they are sourced from self-sustaining colonies.

For the purposes of this Article a ‘self-sustaining colony’ means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans.

The Commission shall, in consultation with the Member States and stakeholders, conduct a feasibility study, which shall include an animal health and welfare assessment, of the requirement laid down in the second subparagraph. The study shall be published no later than ... (12). It shall be accompanied, where appropriate, by proposals for amendments to Annex II.

2.   The Commission shall keep under review the use of sourcing non-human primates from self-sustaining colonies and, in consultation with the Member States and stakeholders, conduct a study to analyse the feasibility of sourcing animals only from self-sustaining colonies.

The study shall be published no later than ... (13).

3.   Competent authorities may grant exemptions from paragraph 1 on the basis of scientific justification.

Article 11

Stray and feral animals of domestic species

1.   Stray and feral animals of domestic species shall not be used in procedures.

2.   The competent authorities may only grant exemptions from paragraph 1 subject to the following conditions:

| (a) | there is an essential need for studies concerning the health and welfare of the animals or serious threats to the environment or to human or animal health, and |
| --- | --- |

(a)

there is an essential need for studies concerning the health and welfare of the animals or serious threats to the environment or to human or animal health, and

| (b) | there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal. |
| --- | --- |

(b)

there is scientific justification to the effect that the purpose of the procedure can be achieved only by the use of a stray or a feral animal.

CHAPTER III

Procedures

Article 12

Procedures

1.   Member States shall ensure that procedures are carried out in a user's establishment.

The competent authority may grant an exemption from the first subparagraph on the basis of scientific justification.

2.   Procedures may be carried out only within the framework of a project.

Article 13

Choice of methods

1.   Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognised under the legislation of the Union.

2.   In choosing between procedures, those which to the greatest extent meet the following requirements shall be selected, that is to say those which:

| (a) | use the minimum number of animals, |
| --- | --- |

(a)

use the minimum number of animals,

| (b) | involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm, |
| --- | --- |

(b)

involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm,

| (c) | cause the least pain, suffering, distress or lasting harm, |
| --- | --- |

(c)

cause the least pain, suffering, distress or lasting harm,

and are most likely to provide satisfactory results.

3.   Death as the end-point of a procedure shall be avoided as far as possible and replaced by early and humane end-points. Where death as the end-point is unavoidable, the procedure shall be designed so as to:

| (a) | result in the deaths of as few animals as possible; and |
| --- | --- |

(a)

result in the deaths of as few animals as possible; and

| (b) | reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death. |
| --- | --- |

(b)

reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death.

Article 14

Anaesthesia

1.   Member States shall ensure that, unless it is inappropriate, procedures are carried out under general or local anaesthesia, and that analgesia or another appropriate method is used to ensure that pain, suffering and distress are kept to a minimum.

Procedures that involve serious injuries that may cause severe pain shall not be carried out without anaesthesia.

2.   When deciding on the appropriateness of using anaesthesia, the following shall be taken into account:

| (a) | whether anaesthesia is judged to be more traumatic to the animal than the procedure itself; and |
| --- | --- |

(a)

whether anaesthesia is judged to be more traumatic to the animal than the procedure itself; and

| (b) | whether anaesthesia is incompatible with the purpose of the procedure. |
| --- | --- |

(b)

whether anaesthesia is incompatible with the purpose of the procedure.

3.   Member States shall ensure that animals are not given any drug to stop or restrict their showing pain without an adequate level of anaesthesia or analgesia.

In these cases, a scientific justification shall be provided, accompanied by the details of the anaesthetic or analgesic regimen.

4.   An animal, which may suffer pain once anaesthesia has worn off, shall be treated with pre-emptive and post-operative analgesics or other appropriate pain-relieving methods provided that it is compatible with the purpose of the procedure.

5.   As soon as the purpose of the procedure has been achieved appropriate action shall be taken to minimise the suffering of the animal.

Article 15

Classification of severity of procedures

1.   Member States shall ensure that all procedures are classified as ‘non-recovery’, ‘mild’, ‘moderate’, or ‘severe’ on a case-by-case basis using the assignment criteria set out in Annex VIII.

2.   Subject to the use of the safeguard clause in Article 55(3), Member States shall ensure that a procedure is not performed if it involves severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated.

Article 16

Reuse

1.   Member States shall ensure that an animal already used in one or more procedures, when a different animal on which no procedure has previously been carried out could also be used, may only be reused in a new procedure provided that the following conditions are met:

| (a) | the actual severity of the previous procedures was ‘mild’ or ‘moderate’; |
| --- | --- |

(a)

the actual severity of the previous procedures was ‘mild’ or ‘moderate’;

| (b) | it is demonstrated that the animal's general state of health and well-being has been fully restored; |
| --- | --- |

(b)

it is demonstrated that the animal's general state of health and well-being has been fully restored;

| (c) | the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and |
| --- | --- |

(c)

the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and

| (d) | it is in accordance with veterinary advice, taking into account the lifetime experience of the animal. |
| --- | --- |

(d)

it is in accordance with veterinary advice, taking into account the lifetime experience of the animal.

2.   In exceptional circumstances, by way of derogation from point (a) of paragraph 1 and after a veterinary examination of the animal, the competent authority may allow reuse of an animal, provided the animal has not been used more than once in a procedure entailing severe pain, distress or equivalent suffering.

Article 17

End of the procedure

1.   A procedure shall be deemed to end when no further observations are to be made for that procedure or, as regards new genetically modified animal lines, when the progeny are no longer observed or expected to experience pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle.

2.   At the end of a procedure, a decision to keep an animal alive shall be taken by a veterinarian or by another competent person. An animal shall be killed when it is likely to remain in moderate or severe pain, suffering, distress or lasting harm.

3.   Where an animal is to be kept alive, it shall receive care and accommodation appropriate to its state of health.

Article 18

Sharing organs and tissues

Member States shall facilitate, where appropriate, the establishment of programmes for the sharing of organs and tissues of animals killed.

Article 19

Setting free of animals and rehoming

Member States may allow animals used or intended to be used in procedures to be rehomed, or returned to a suitable habitat or husbandry system appropriate to the species, provided that the following conditions are met:

| (a) | the state of health of the animal allows it; |
| --- | --- |

(a)

the state of health of the animal allows it;

| (b) | there is no danger to public health, animal health or the environment; and |
| --- | --- |

(b)

there is no danger to public health, animal health or the environment; and

| (c) | appropriate measures have been taken to safeguard the well-being of the animal. |
| --- | --- |

(c)

appropriate measures have been taken to safeguard the well-being of the animal.

CHAPTER IV

Authorisation

Section 1

REQUIREMENTS FOR BREEDERS, SUPPLIERS AND USERS

Article 20

Authorisation of breeders, suppliers and users

1.   Member States shall ensure that all breeders, suppliers and users are authorised by, and registered with, the competent authority. Such authorisation may be granted for a limited period.

Authorisation shall be granted only if the breeder, supplier or user and its establishment is in compliance with the requirements of this Directive.

2.   The authorisation shall specify the person responsible for ensuring compliance with the provisions of this Directive and the person or persons referred to in Article 24(1) and in Article 25.

3.   Renewal of the authorisation shall be required for any significant change to the structure or the function of an establishment of a breeder, supplier or user that could negatively affect animal welfare.

4.   Member States shall ensure that the competent authority is notified of any changes of the person or persons referred to in paragraph 2.

Article 21

Suspension and withdrawal of authorisation

1.   Where a breeder, supplier or user no longer complies with the requirements set out in this Directive, the competent authority shall take appropriate remedial action, or require such action to be taken, or suspend or withdraw its authorisation.

2.   Member States shall ensure that, where the authorisation is suspended or withdrawn, the welfare of the animals housed in the establishment is not adversely affected.

Article 22

Requirements for installations and equipment

1.   Member States shall ensure that all establishments of a breeder, supplier or user have installations and equipment suited to the species of animals housed and, where procedures are carried out, to the performance of the procedures.

2.   The design, construction and method of functioning of the installations and equipment referred to in paragraph 1 shall ensure that the procedures are carried out as effectively as possible, and aim at obtaining reliable results using the minimum number of animals and causing the minimum degree of pain, suffering, distress or lasting harm.

3.   For the purposes of implementation of paragraphs 1 and 2, Member States shall ensure that the relevant requirements as set out in Annex III are complied with.

Article 23

Competence of personnel

1.   Member States shall ensure that each breeder, supplier and user has sufficient staff on site.

2.   The staff shall be adequately educated and trained before they perform any of the following functions:

| (a) | carrying out procedures on animals; |
| --- | --- |

(a)

carrying out procedures on animals;

| (b) | designing procedures and projects; |
| --- | --- |

(b)

designing procedures and projects;

| (c) | taking care of animals; or |
| --- | --- |

(c)

taking care of animals; or

| (d) | killing animals. |
| --- | --- |

(d)

killing animals.

Persons carrying out the functions referred to in point (b) shall have received instruction in a scientific discipline relevant to the work being undertaken and shall have species-specific knowledge.

Staff carrying out functions referred to in points (a), (c) or (d) shall be supervised in the performance of their tasks until they have demonstrated the requisite competence.

Member States shall ensure, through authorisation or by other means, that the requirements laid down in this paragraph are fulfilled.

3.   Member States shall publish, on the basis of the elements set out in Annex V, minimum requirements with regard to education and training and the requirements for obtaining, maintaining and demonstrating requisite competence for the functions set out in paragraph 2.

4.   Non-binding guidelines at the level of the Union on the requirements laid down in paragraph 2 may be adopted in accordance with the advisory procedure referred to in Article 56(2).

Article 24

Specific requirements for personnel

1.   Member States shall ensure that each breeder, supplier and user has one or several persons on site who shall:

| (a) | be responsible for overseeing the welfare and care of the animals in the establishment; |
| --- | --- |

(a)

be responsible for overseeing the welfare and care of the animals in the establishment;

| (b) | ensure that the staff dealing with animals have access to information specific to the species housed in the establishment; |
| --- | --- |

(b)

ensure that the staff dealing with animals have access to information specific to the species housed in the establishment;

| (c) | be responsible for ensuring that the staff are adequately educated, competent and continuously trained and that they are supervised until they have demonstrated the requisite competence. |
| --- | --- |

(c)

be responsible for ensuring that the staff are adequately educated, competent and continuously trained and that they are supervised until they have demonstrated the requisite competence.

2.   Member States shall ensure that persons specified in Article 40(2)(b) shall:

| (a) | ensure that any unnecessary pain, suffering, distress or lasting harm that is being inflicted on an animal in the course of a procedure is stopped; and |
| --- | --- |

(a)

ensure that any unnecessary pain, suffering, distress or lasting harm that is being inflicted on an animal in the course of a procedure is stopped; and

| (b) | ensure that the projects are carried out in accordance with the project authorisation or, in the cases referred to in Article 42, in accordance with the application sent to the competent authority or any decision taken by the competent authority, and ensure that in the event of non-compliance, the appropriate measures to rectify it are taken and recorded. |
| --- | --- |

(b)

ensure that the projects are carried out in accordance with the project authorisation or, in the cases referred to in Article 42, in accordance with the application sent to the competent authority or any decision taken by the competent authority, and ensure that in the event of non-compliance, the appropriate measures to rectify it are taken and recorded.

Article 25

Designated veterinarian

Member States shall ensure that each breeder, supplier and user has a designated veterinarian with expertise in laboratory animal medicine, or a suitably qualified expert where more appropriate, charged with advisory duties in relation to the well-being and treatment of the animals.

Article 26

Animal-welfare body

1.   Member States shall ensure that each breeder, supplier and user sets up an animal-welfare body.

2.   The animal-welfare body shall include at least the person or persons responsible for the welfare and care of the animals and, in the case of a user, a scientific member. The animal-welfare body shall also receive input from the designated veterinarian or the expert referred to in Article 25.

3.   Member States may allow small breeders, suppliers and users to fulfil the tasks laid down in Article 27(1) by other means.

Article 27

Tasks of the animal-welfare body

1.   The animal-welfare body shall, as a minimum, carry out the following tasks:

| (a) | advise the staff dealing with animals on matters related to the welfare of animals, in relation to their acquisition, accommodation, care and use; |
| --- | --- |

(a)

advise the staff dealing with animals on matters related to the welfare of animals, in relation to their acquisition, accommodation, care and use;

| (b) | advise the staff on the application of the requirement of replacement, reduction and refinement, and keep it informed of technical and scientific developments concerning the application of that requirement; |
| --- | --- |

(b)

advise the staff on the application of the requirement of replacement, reduction and refinement, and keep it informed of technical and scientific developments concerning the application of that requirement;

| (c) | establish and review internal operational processes as regards monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the establishment; |
| --- | --- |

(c)

establish and review internal operational processes as regards monitoring, reporting and follow-up in relation to the welfare of animals housed or used in the establishment;

| (d) | follow the development and outcome of projects, taking into account the effect on the animals used, and identify and advise as regards elements that further contribute to replacement, reduction and refinement; and |
| --- | --- |

(d)

follow the development and outcome of projects, taking into account the effect on the animals used, and identify and advise as regards elements that further contribute to replacement, reduction and refinement; and

| (e) | advise on rehoming schemes, including the appropriate socialisation of the animals to be rehomed. |
| --- | --- |

(e)

advise on rehoming schemes, including the appropriate socialisation of the animals to be rehomed.

2.   Member States shall ensure that the records of any advice given by the animal-welfare body and decisions taken regarding that advice are kept for at least three years.

The records shall be made available to the competent authority upon request.

Article 28

Breeding strategy for non-human primates

Member States shall ensure that breeders of non-human primates have a strategy in place for increasing the proportion of animals that are the offspring of non-human primates that have been bred in captivity.

Article 29

Scheme for rehoming or setting free of animals

Where Member States allow rehoming, the breeders, suppliers and users from which animals are intended to be rehomed shall have a rehoming scheme in place that ensures socialisation of the animals that are rehomed. In the case of wild animals, where appropriate, a programme of rehabilitation shall be in place before they are returned to their habitat.

Article 30

Animal records

1.   Member States shall ensure that all breeders, suppliers and users keep records of at least the following:

| (a) | the number and the species of animals bred, acquired, supplied, used in procedures, set-free or rehomed; |
| --- | --- |

(a)

the number and the species of animals bred, acquired, supplied, used in procedures, set-free or rehomed;

| (b) | the origin of the animals, including whether they are bred for use in procedures; |
| --- | --- |

(b)

the origin of the animals, including whether they are bred for use in procedures;

| (c) | the dates on which the animals are acquired, supplied, released or rehomed; |
| --- | --- |

(c)

the dates on which the animals are acquired, supplied, released or rehomed;

| (d) | from whom the animals are acquired; |
| --- | --- |

(d)

from whom the animals are acquired;

| (e) | the name and address of the recipient of animals; |
| --- | --- |

(e)

the name and address of the recipient of animals;

| (f) | the number and species of animals which died or were killed in each establishment. For animals that have died, the cause of death shall, when known, be noted; and |
| --- | --- |

(f)

the number and species of animals which died or were killed in each establishment. For animals that have died, the cause of death shall, when known, be noted; and

| (g) | in the case of users, the projects in which animals are used. |
| --- | --- |

(g)

in the case of users, the projects in which animals are used.

2.   The records referred to in paragraph 1 shall be kept for a minimum of five years and made available to the competent authority upon request.

Article 31

Information on dogs, cats and non-human primates

1.   Member States shall ensure that all breeders, suppliers and users keep the following information on each dog, cat and non-human primate:

| (a) | identity; |
| --- | --- |

(a)

identity;

| (b) | place and date of birth, when available; |
| --- | --- |

(b)

place and date of birth, when available;

| (c) | whether it is bred for use in procedures; and |
| --- | --- |

(c)

whether it is bred for use in procedures; and

| (d) | in the case of a non-human primate, whether it is the offspring of non-human primates that have been bred in captivity. |
| --- | --- |

(d)

in the case of a non-human primate, whether it is the offspring of non-human primates that have been bred in captivity.

2.   Each dog, cat and non-human primate shall have an individual history file, which follows the animal as long as it is kept for the purposes of this Directive.

The file shall be established at birth or as soon as possible thereafter and shall cover any relevant reproductive, veterinary and social information on the individual animal and the projects in which it has been used.

3.   The information referred to in this Article shall be kept for a minimum of three years after the death or rehoming of the animal and shall be made available to the competent authority upon request.

In the case of rehoming, relevant veterinary care and social information from the individual history file referred to in paragraph 2 shall accompany the animal.

Article 32

Marking and identification of dogs, cats and non-human primates

1.   Each dog, cat or non-human primate shall be provided, at the latest at the time of weaning, with a permanent individual identification mark in the least painful manner possible.

2.   Where a dog, cat or non-human primate is transferred from one breeder, supplier or user to another before it is weaned, and it is not practicable to mark it beforehand, a record, specifying in particular its mother, must be maintained by the receiver until it is marked.

3.   Where an unmarked dog, cat or non-human primate, which is weaned, is received by a breeder, supplier or user it shall be permanently marked as soon as possible and in the least painful manner possible.

4.   The breeder, supplier and user shall provide, at the request of the competent authority, reasons for which the animal is unmarked.

Article 33

Care and accommodation

1.   Member States shall, as far as the care and accommodation of animals is concerned, ensure that:

| (a) | all animals are provided with accommodation, an environment, food, water and care which are appropriate to their health and well-being; |
| --- | --- |

(a)

all animals are provided with accommodation, an environment, food, water and care which are appropriate to their health and well-being;

| (b) | any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum; |
| --- | --- |

(b)

any restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum;

| (c) | the environmental conditions in which animals are bred, kept or used are checked daily; |
| --- | --- |

(c)

the environmental conditions in which animals are bred, kept or used are checked daily;

| (d) | arrangements are made to ensure that any defect or avoidable pain, suffering, distress or lasting harm discovered is eliminated as quickly as possible; and |
| --- | --- |

(d)

arrangements are made to ensure that any defect or avoidable pain, suffering, distress or lasting harm discovered is eliminated as quickly as possible; and

| (e) | animals are transported under appropriate conditions. |
| --- | --- |

(e)

animals are transported under appropriate conditions.

2.   For the purposes of paragraph 1, Member States shall ensure that the care and accommodation standards set out in Annex III are applied from the dates provided for therein.

3.   Member States may allow exemptions from the requirements of paragraph 1(a) or paragraph 2 for scientific, animal-welfare or animal-health reasons.

Section 2

INSPECTIONS

Article 34

Inspections by the Member States

1.   Member States shall ensure that the competent authorities carry out regular inspections of all breeders, suppliers and users, including their establishments, to verify compliance with the requirements of this Directive.

2.   The competent authority shall adapt the frequency of inspections on the basis of a risk analysis for each establishment, taking account of:

| (a) | the number and species of animals housed; |
| --- | --- |

(a)

the number and species of animals housed;

| (b) | the record of the breeder, supplier or user in complying with the requirements of this Directive; |
| --- | --- |

(b)

the record of the breeder, supplier or user in complying with the requirements of this Directive;

| (c) | the number and types of projects carried out by the user in question; and |
| --- | --- |

(c)

the number and types of projects carried out by the user in question; and

| (d) | any information that might indicate non-compliance. |
| --- | --- |

(d)

any information that might indicate non-compliance.

3.   Inspections shall be carried out on at least one third of the users each year in accordance with the risk analysis referred to in paragraph 2. However, breeders, suppliers and users of non-human primates shall be inspected at least once a year.

4.   An appropriate proportion of the inspections shall be carried out without prior warning.

5.   Records of all inspections shall be kept for at least five years.

Article 35

Controls of Member State inspections

1.   The Commission shall, when there is due reason for concern, taking into account inter alia the proportion of inspections carried out without prior warning, undertake controls of the infrastructure and operation of national inspections in Member States.

2.   The Member State in the territory of which the control referred to in paragraph 1 is being carried out shall give all necessary assistance to the experts of the Commission in carrying out their duties. The Commission shall inform the competent authority of the Member State concerned of the results of the control.

3.   The competent authority of the Member State concerned shall take measures to take account of the results of the control referred to in paragraph 1.

Section 3

REQUIREMENTS FOR PROJECTS

Article 36

Project authorisation

1.   Member States shall ensure, without prejudice to Article 42, that projects are not carried out without prior authorisation from the competent authority, and that projects are carried out in accordance with the authorisation or, in the cases referred to in Article 42, in accordance with the application sent to the competent authority or any decision taken by the competent authority.

2.   Member States shall ensure that no project is carried out unless a favourable project evaluation by the competent authority has been received in accordance with Article 38.

Article 37

Application for project authorisation

1.   Member States shall ensure that an application for project authorisation is submitted by the user or the person responsible for the project. The application shall include at least the following:

| (a) | the project proposal; |
| --- | --- |

(a)

the project proposal;

| (b) | a non-technical project summary; and |
| --- | --- |

(b)

a non-technical project summary; and

| (c) | information on the elements set out in Annex VI. |
| --- | --- |

(c)

information on the elements set out in Annex VI.

2.   Member States may waive the requirement in paragraph 1(b) for projects referred to in Article 42(1).

Article 38

Project evaluation

1.   The project evaluation shall be performed with a degree of detail appropriate for the type of project and shall verify that the project meets the following criteria:

| (a) | the project is justified from a scientific or educational point of view or required by law; |
| --- | --- |

(a)

the project is justified from a scientific or educational point of view or required by law;

| (b) | the purposes of the project justify the use of animals; and |
| --- | --- |

(b)

the purposes of the project justify the use of animals; and

| (c) | the project is designed so as to enable procedures to be carried out in the most humane and environmentally sensitive manner possible. |
| --- | --- |

(c)

the project is designed so as to enable procedures to be carried out in the most humane and environmentally sensitive manner possible.

2.   The project evaluation shall consist in particular of the following:

| (a) | an evaluation of the objectives of the project, the predicted scientific benefits or educational value; |
| --- | --- |

(a)

an evaluation of the objectives of the project, the predicted scientific benefits or educational value;

| (b) | an assessment of the compliance of the project with the requirement of replacement, reduction and refinement; |
| --- | --- |

(b)

an assessment of the compliance of the project with the requirement of replacement, reduction and refinement;

| (c) | an assessment and assignment of the classification of the severity of procedures; |
| --- | --- |

(c)

an assessment and assignment of the classification of the severity of procedures;

| (d) | a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and may ultimately benefit human beings, animals or the environment; |
| --- | --- |

(d)

a harm-benefit analysis of the project, to assess whether the harm to the animals in terms of suffering, pain and distress is justified by the expected outcome taking into account ethical considerations, and may ultimately benefit human beings, animals or the environment;

| (e) | an assessment of any justification referred to in Articles 6 to 12, 14, 16, and 33; and |
| --- | --- |

(e)

an assessment of any justification referred to in Articles 6 to 12, 14, 16, and 33; and

| (f) | a determination as to whether and when the project should be assessed retrospectively. |
| --- | --- |

(f)

a determination as to whether and when the project should be assessed retrospectively.

3.   The competent authority carrying out the project evaluation shall consider expertise in particular in the following areas:

| (a) | the areas of scientific use for which animals will be used including replacement, reduction and refinement in the respective areas; |
| --- | --- |

(a)

the areas of scientific use for which animals will be used including replacement, reduction and refinement in the respective areas;

| (b) | experimental design, including statistics where appropriate; |
| --- | --- |

(b)

experimental design, including statistics where appropriate;

| (c) | veterinary practice in laboratory animal science or wildlife veterinary practice where appropriate; |
| --- | --- |

(c)

veterinary practice in laboratory animal science or wildlife veterinary practice where appropriate;

| (d) | animal husbandry and care, in relation to the species that are intended to be used. |
| --- | --- |

(d)

animal husbandry and care, in relation to the species that are intended to be used.

4.   The project evaluation process shall be transparent.

Subject to safeguarding intellectual property and confidential information, the project evaluation shall be performed in an impartial manner and may integrate the opinion of independent parties.

Article 39

Retrospective assessment

1.   Member States shall ensure that when determined in accordance with Article 38(2)(f), the retrospective assessment shall be carried out by the competent authority which shall, on the basis of the necessary documentation submitted by the user, evaluate the following:

| (a) | whether the objectives of the project were achieved; |
| --- | --- |

(a)

whether the objectives of the project were achieved;

| (b) | the harm inflicted on animals, including the numbers and species of animals used, and the severity of the procedures; and |
| --- | --- |

(b)

the harm inflicted on animals, including the numbers and species of animals used, and the severity of the procedures; and

| (c) | any elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement. |
| --- | --- |

(c)

any elements that may contribute to the further implementation of the requirement of replacement, reduction and refinement.

2.   All projects using non-human primates and projects involving procedures classified as ‘severe’, including those referred to in Article 15(2), shall undergo a retrospective assessment.

3.   Without prejudice to paragraph 2 and by way of derogation from Article 38(2)(f), Member States may exempt projects involving only procedures classified as ‘mild’ or ‘non-recovery’ from the requirement for a retrospective assessment.

Article 40

Granting of project authorisation

1.   The project authorisation shall be limited to procedures which have been subject to:

| (a) | a project evaluation; and |
| --- | --- |

(a)

a project evaluation; and

| (b) | the severity classifications assigned to those procedures. |
| --- | --- |

(b)

the severity classifications assigned to those procedures.

2.   The project authorisation shall specify the following:

| (a) | the user who undertakes the project; |
| --- | --- |

(a)

the user who undertakes the project;

| (b) | the persons responsible for the overall implementation of the project and its compliance with the project authorisation; |
| --- | --- |

(b)

the persons responsible for the overall implementation of the project and its compliance with the project authorisation;

| (c) | the establishments in which the project will be undertaken, where applicable; and |
| --- | --- |

(c)

the establishments in which the project will be undertaken, where applicable; and

| (d) | any specific conditions following the project evaluation, including whether and when the project shall be assessed retrospectively. |
| --- | --- |

(d)

any specific conditions following the project evaluation, including whether and when the project shall be assessed retrospectively.

3.   Project authorisations shall be granted for a period not exceeding five years.

4.   Member States may allow the authorisation of multiple generic projects carried out by the same user if such projects are to satisfy regulatory requirements or if such projects use animals for production or diagnostic purposes with established methods.

Article 41

Authorisation decisions

1.   Member States shall ensure that the decision regarding authorisation is taken and communicated to the applicant 40 working days at the latest from the receipt of the complete and correct application. This period shall include the project evaluation.

2.   When justified by the complexity or the multi-disciplinary nature of the project, the competent authority may extend the period referred to in paragraph 1 once, by an additional period not exceeding 15 working days. The extension and its duration shall be duly motivated and shall be notified to the applicant before the expiry of the period referred to in paragraph 1.

3.   Competent authorities shall acknowledge to the applicant all applications for authorisations as quickly as possible, and shall indicate the period referred to in paragraph 1 within which the decision is to be taken.

4.   In the case of an incomplete or incorrect application, the competent authority shall, as quickly as possible, inform the applicant of the need to supply any additional documentation and of any possible effects on the running of the applicable time period.

Article 42

Simplified administrative procedure

1.   Member States may decide to introduce a simplified administrative procedure for projects containing procedures classified as ‘non-recovery’, ‘mild’ or ‘moderate’ and not using non-human primates, that are necessary to satisfy regulatory requirements, or which use animals for production or diagnostic purposes with established methods.

2.   When introducing a simplified administrative procedure, Member States shall ensure that the following provisions are met:

| (a) | the application specifies elements referred to in Article 40(2)(a), (b) and (c); |
| --- | --- |

(a)

the application specifies elements referred to in Article 40(2)(a), (b) and (c);

| (b) | a project evaluation is performed in accordance with Article 38; and |
| --- | --- |

(b)

a project evaluation is performed in accordance with Article 38; and

| (c) | that the period referred to in Article 41(1) is not exceeded. |
| --- | --- |

(c)

that the period referred to in Article 41(1) is not exceeded.

3.   If a project is changed in a way that may have a negative impact on animal welfare, Member States shall require an additional project evaluation with a favourable outcome.

4.   Article 40(3) and (4), Article 41(3) and Article 44(3), (4) and (5) shall apply mutatis mutandis to projects that are allowed to be carried out in accordance with this Article.

Article 43

Non-technical project summaries

1.   Subject to safeguarding intellectual property and confidential information, the non-technical project summary shall provide the following:

| (a) | information on the objectives of the project, including the predicted harm and benefits and the number and types of animals to be used; |
| --- | --- |

(a)

information on the objectives of the project, including the predicted harm and benefits and the number and types of animals to be used;

| (b) | a demonstration of compliance with the requirement of replacement, reduction and refinement. |
| --- | --- |

(b)

a demonstration of compliance with the requirement of replacement, reduction and refinement.

The non-technical project summary shall be anonymous and shall not contain the names and addresses of the user and its personnel.

2.   Member States may require the non-technical project summary to specify whether a project is to undergo a retrospective assessment and by what deadline. In such a case, Member States shall ensure that the non-technical project summary is updated with the results of any retrospective assessment.

3.   Member States shall publish the non-technical project summaries of authorised projects and any updates thereto.

Article 44

Amendment, renewal and withdrawal of a project authorisation

1.   Member States shall ensure that amendment or renewal of the project authorisation is required for any change of the project that may have a negative impact on animal welfare.

2.   Any amendment or renewal of a project authorisation shall be subject to a further favourable outcome of the project evaluation.

3.   The competent authority may withdraw the project authorisation where the project is not carried out in accordance with the project authorisation.

4.   Where a project authorisation is withdrawn, the welfare of the animals used or intended to be used in the project must not be adversely affected.

5.   Member States shall establish and publish conditions for amendment and renewal of project authorisations.

Article 45

Documentation

1.   Member States shall ensure that all relevant documentation, including project authorisations and the result of the project evaluation is kept for at least three years from the expiry date of the authorisation of the project or from the expiry of the period referred to in Article 41(1) and shall be available to the competent authority.

2.   Without prejudice to paragraph 1, the documentation for projects which have to undergo retrospective assessment shall be kept until the retrospective assessment has been completed.

CHAPTER V

Avoidance of duplication and alternative approaches

Article 46

Avoidance of duplication of procedures

Each Member State shall accept data from other Member States that are generated by procedures recognised by the legislation of the Union, unless further procedures need to be carried out regarding that data for the protection of public health, safety or the environment.

Article 47

Alternative approaches

1.   The Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field.

2.   Member States shall assist the Commission in identifying and nominating suitable specialised and qualified laboratories to carry out such validation studies.

3.   After consulting the Member States, the Commission shall set the priorities for those validation studies and allocate the tasks between the laboratories for carrying out those studies.

4.   Member States shall, at national level, ensure the promotion of alternative approaches and the dissemination of information thereon.

5.   Member States shall nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation.

6.   The Commission shall take appropriate action with a view to obtaining international acceptance of alternative approaches validated in the Union.

Article 48

Union Reference Laboratory

1.   The Union Reference Laboratory and its duties and tasks shall be those referred to in Annex VII.

2.   The Union Reference Laboratory may collect charges for the services it provides that do not directly contribute to the further advancement of replacement, reduction and refinement.

3.   Detailed rules necessary for the implementation of paragraph 2 of this Article and Annex VII may be adopted in accordance with the regulatory procedure referred to in Article 56(3).

Article 49

National committees for the protection of animals used for scientific purposes

1.   Each Member State shall establish a national committee for the protection of animals used for scientific purposes. It shall advise the competent authorities and animal-welfare bodies on matters dealing with the acquisition, breeding, accommodation, care and use of animals in procedures and ensure sharing of best practice.

2.   The national committees referred to in paragraph 1 shall exchange information on the operation of animal-welfare bodies and project evaluation and share best practice within the Union.

CHAPTER VI

Final provisions

Article 50

Adaptation of annexes to technical progress

In order to ensure that the provisions of Annexes I and III to VIII reflect the state of technical or scientific progress, taking into account the experience gained in the implementation of this Directive, in particular through the reporting referred to in Article 54(1), the Commission may adopt, by means of delegated acts in accordance with Article 51 and subject to the conditions laid down in Articles 52 and 53, modifications of those Annexes, with the exception of provisions of Sections I and II of Annex VIII. The dates referred to in Section B of Annex III shall not be brought forward. When adopting such delegated acts, the Commission shall act in accordance with the relevant provisions of this Directive.

Article 51

Exercise of the delegation

1.   The power to adopt delegated acts referred to in Article 50 shall be conferred on the Commission for a period of eight years beginning on ... (9). The Commission shall make a report in respect of the delegated power at the latest 12 months before the end of the eight-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 52.

2.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

3.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 52 and 53.

Article 52

Revocation of the delegation

1.   The delegation of power referred to in Article 50 may be revoked at any time by the European Parliament or by the Council.

2.   The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated power which could be subject to revocation and possible reasons for a revocation.

3.   The decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

Article 53

Objections to delegated acts

1.   The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification.

At the initiative of the European Parliament or the Council this period shall be extended by two months.

2.   If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein.

The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.

3.   If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

Article 54

Reporting

1.   Member States shall by ... (14), and every five years thereafter, send the information on the implementation of this Directive and in particular Articles 10(1), 26, 28, 34, 38, 39, 43 and 46 to the Commission.

2.   Member States shall collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures, including information on the actual severity of the procedures and on the origin and species of non-human primates used in procedures.

Member States shall submit that statistical information to the Commission by ... (15) and every year thereafter.

3.   Member States shall submit to the Commission, on annual basis, detailed information on exemptions granted under Article 6(4)(a).

4.   The Commission shall by ... (16) establish a common format for submitting the information referred to in paragraphs 1, 2, and 3 of this Article in accordance with the regulatory procedure referred to in Article 56(3).

Article 55

Safeguard clauses

1.   Where a Member State has scientifically justifiable grounds for believing it is essential to use non-human primates for the purposes referred to in Article 8(1)(a)(i) with regard to human beings, but where the use is not undertaken with a view to the avoidance, prevention, diagnosis or treatment of debilitating or potentially life-threatening clinical conditions, it may adopt a provisional measure allowing such use, provided the purpose cannot be achieved by the use of species other than non-human primates.

2.   Where a Member State has justifiable grounds for believing that action is essential for the preservation of the species or in relation to an unexpected outbreak of a life-threatening or debilitating clinical condition in human beings, it may adopt a provisional measure allowing the use of great apes in procedures having one of the purposes referred to in points (b)(i), (c) or (e) of Article 5; provided that the purpose of the procedure cannot be achieved by the use of species other than great apes or by the use of alternative methods. However, the reference to Article 5(b)(i) shall not be taken to include the reference to animals and plants.

3.   Where, for exceptional and scientifically justifiable reasons, a Member State deems it necessary to allow the use of a procedure involving severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated, as referred to in Article 15(2), it may adopt a provisional measure to allow such procedure. Member States may decide not to allow the use of non-human primates in such procedures.

4.   A Member State which has adopted a provisional measure in accordance with paragraph 1, 2 or 3 shall immediately inform the Commission and the other Member States thereof, giving reasons for its decision and submitting evidence of the situation as described in paragraphs 1, 2 and 3 on which the provisional measure is based.

The Commission shall put the matter before the Committee referred to in Article 56(1) within 30 days of receipt of the information from the Member State and shall, in accordance with the regulatory procedure referred to in Article 56(3), either:

| (a) | authorise the provisional measure for a time period defined in the decision; or |
| --- | --- |

(a)

authorise the provisional measure for a time period defined in the decision; or

| (b) | require the Member State to revoke the provisional measure. |
| --- | --- |

(b)

require the Member State to revoke the provisional measure.

Article 56

Committee

1.   The Commission shall be assisted by a Committee.

2.   Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Article 57

Commission report

1.   By ... (17) and every five years thereafter, the Commission shall, based on the information received from the Member States under Article 54(1), submit to the European Parliament and the Council a report on the implementation of this Directive.

2.   By ... (17) and every three years thereafter, the Commission shall, based on the statistical information submitted by Member States under Article 54(2), submit to the European Parliament and the Council a summary report on that information.

Article 58

Review

The Commission shall review this Directive by ... (12), taking into account advancements in the development of alternative methods not entailing the use of animals, in particular of non-human primates, and shall propose amendments, where appropriate.

The Commission shall, where appropriate, and in consultation with the Member States and stakeholders, conduct periodic thematic reviews of the replacement, reduction and refinement of the use of animals in procedures, paying specific attention to non-human primates, technological developments, and new scientific and animal-welfare knowledge.

Article 59

Competent authorities

1.   Each Member State shall designate one or more competent authorities responsible for the implementation of this Directive.

Member States may designate bodies other than public authorities for the implementation of specific tasks laid down in this Directive only if there is proof that the body:

| (a) | has the expertise and infrastructure required to carry out the tasks; and |
| --- | --- |

(a)

has the expertise and infrastructure required to carry out the tasks; and

| (b) | is free of any conflict of interests as regards the performance of the tasks. |
| --- | --- |

(b)

is free of any conflict of interests as regards the performance of the tasks.

Bodies thus designated shall be considered competent authorities for the purposes of this Directive.

2.   Each Member State shall communicate details of a national authority serving as contact point for the purposes of this Directive to the Commission by ... (18), as well as any update to such data.

The Commission shall make publicly available the list of those contact points.

Article 60

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by ... (19), and shall notify the Commission without delay of any subsequent amendment affecting them.

Article 61

Transposition

1.   Member States shall adopt and publish, by ... (20), the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

They shall apply those provisions from ... (10).

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The method of making such reference shall be laid down by Member States.

2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 62

Repeal

1.   Directive 86/609/EEC is repealed with effect from ... (10) with the exception of Article 13, which shall be repealed with the effect from ... (21).

2.   References to the repealed Directive shall be construed as references to this Directive.

Article 63

Amendment of Regulation (EC) No 1069/2009

Point (a)(iv) of Article 8 of Regulation (EC) No 1069/2009 is replaced by the following:

| ‘(iv) | animals used in a procedure or procedures defined in Article 3 of Directive .../.../EU of ... on the protection of animals used for scientific purposes (22), in cases where the competent authority decides that such animals or any of their body parts have the potential to pose serious health risks to humans or to other animals, as a result of that procedure or those procedures without prejudice to Article 3(2) of Regulation (EC) No 1831/2003; |
| --- | --- |

‘(iv)

animals used in a procedure or procedures defined in Article 3 of Directive .../.../EU of ... on the protection of animals used for scientific purposes (22), in cases where the competent authority decides that such animals or any of their body parts have the potential to pose serious health risks to humans or to other animals, as a result of that procedure or those procedures without prejudice to Article 3(2) of Regulation (EC) No 1831/2003;

Article 64

Transitional provisions

1.   Member States shall not apply laws, regulations and administrative provisions adopted in accordance with Articles 36 to 45 to projects which have been approved before ... (10) and the duration of which does not extend beyond ... (23).

10

23

2.   Projects which have been approved before ... (10) and the duration of which extends beyond ... (10) shall obtain project authorisation by ... (23).

10

10

23

Article 65

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

Article 66

Addressees

This Directive is addressed to the Member States.

Done at ...

For the European Parliament

The President

...

For the Council

The President

...

---

(1)  OJ C 277, 17.11.2009, p. 51.

1

(2)  Position of the European Parliament of 5 May 2009 (not yet published in the Official Journal), Position of the Council of 3 June 2010, Position of the European Parliament of ... (not yet published in the Official Journal) (and Decision of the Council of ...).

2

(3)  OJ L 358, 18.12.1986, p. 1.

3

(4)  OJ L 222, 24.8.1999, p. 29.

4

(5)  OJ L 197, 30.7.2007, p. 1.

5

(6)  OJ L 184, 17.7.1999, p. 23.

6

(7)  OJ L 300, 14.11.2009, p. 1.

7

(8)  OJ L 262, 27.9.1976, p. 169. Directive recast by Regulation (EC) No 1223/2009 of the European Parliament and the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), which applies as from 11 July 2013.

8

(9)  Date of entry into force of this Directive.

9

(10)  1 January of the third year following the date of entry into force of this Directive.

10

(11)  OJ L 61, 3.3.1997, p. 1.

11

(12)  7 years after the date of entry into force of this Directive.

12

(13)  12 years after the date of entry into force of this Directive.

13

(14)  8 years from the date of entry into force of this Directive.

14

(15)  5 years from the date of entry into force of this Directive.

15

(16)  18 months from the entry into force of this Directive.

16

(17)  9 years after the date of entry into force of this Directive.

17

(18)  Three months after the entry into force of this Directive.

18

(19)  27 months following the date of entry into force of this Directive.

19

(20)  24 months from the entry into force of this Directive.

20

(21)  30 months from the entry into force of this Directive.

21

(22)  OJ L ...’.

22

(23)  1 January of the eighth year following the date of entry into force of this Directive.

23

---

ANNEX I

List of animals referred to in Article 10

1.   Mouse (Mus musculus)

2.   Rat (Rattus norvegicus)

3.   Guinea pig (Cavia porcellus)

4.   Syrian (golden) hamster (Mesocricetus auratus)

5.   Chinese hamster (Cricetulus griseus)

6.   Mongolian gerbil (Meriones unguiculatus)

7.   Rabbit (Oryctolagus cuniculus)

8.   Dog (Canis familiaris)

9.   Cat (Felis catus)

10.   All species of non-human primates

11.   Frog (Xenopus (laevis, tropicalis), Rana (temporaria, pipiens))

12.   Zebra fish (Danio rerio)

---

ANNEX II

List of non-human primates and dates referred to in the second subparagraph of Article 10(1)

| Species | Dates |
| --- | --- |
| Marmoset (Callithrix jacchus) | 1 January ...
   (1) |
| Cynomolgus monkey (Macaca fascicularis) | 5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period |
| Rhesus monkey (Macaca mulatta) | 5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period |
| Other species of non-human primates | 5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period |

Species

Dates

Marmoset (Callithrix jacchus)

1 January ...
   (1)

Cynomolgus monkey (Macaca fascicularis)

5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period

Rhesus monkey (Macaca mulatta)

5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period

Other species of non-human primates

5 years after the publication of the feasibility study referred to in Article 10(1), fourth subparagraph, provided the study does not recommend an extended period

---

(1)  1 January of the third year following the date of entry into force of this Directive.

---

ANNEX III

Requirements for establishments and for the care and accommodation of animals

SECTION A: GENERAL SECTION

| 1. | The physical facilities |
| --- | --- |

1.

| 1.1. | Functions and general design






  (a) | All facilities shall be constructed so as to provide an environment which takes into account the physiological and ethological needs of the species kept in them. Facilities shall also be designed and managed to prevent access by unauthorised persons and the ingress or escape of animals. |
| --- | --- | --- |

1.1.

(a)

All facilities shall be constructed so as to provide an environment which takes into account the physiological and ethological needs of the species kept in them. Facilities shall also be designed and managed to prevent access by unauthorised persons and the ingress or escape of animals.

| (b) | Establishments shall have an active maintenance programme to prevent and remedy any defect in buildings or equipment. |
| --- | --- |

(b)

Establishments shall have an active maintenance programme to prevent and remedy any defect in buildings or equipment.

| 1.2. | Holding rooms






  (a) | Establishments shall have a regular and efficient cleaning schedule for the rooms and shall maintain satisfactory hygienic standards. |
| --- | --- | --- |

1.2.

(a)

Establishments shall have a regular and efficient cleaning schedule for the rooms and shall maintain satisfactory hygienic standards.

| (b) | Walls and floors shall be surfaced with a material resistant to the heavy wear and tear caused by the animals and the cleaning process. The material shall not be detrimental to the health of the animals and shall be such that the animals cannot hurt themselves. Additional protection shall be given to any equipment or fixtures so that they are not damaged by the animals nor do they cause injury to the animals themselves. |
| --- | --- |

(b)

Walls and floors shall be surfaced with a material resistant to the heavy wear and tear caused by the animals and the cleaning process. The material shall not be detrimental to the health of the animals and shall be such that the animals cannot hurt themselves. Additional protection shall be given to any equipment or fixtures so that they are not damaged by the animals nor do they cause injury to the animals themselves.

| (c) | Species that are incompatible, for example predator and prey, or animals requiring different environmental conditions, shall not be housed in the same room nor, in the case of predator and prey, within sight, smell or sound of each other. |
| --- | --- |

(c)

Species that are incompatible, for example predator and prey, or animals requiring different environmental conditions, shall not be housed in the same room nor, in the case of predator and prey, within sight, smell or sound of each other.

| 1.3. | General and special purpose procedure rooms






  (a) | Establishments shall, where appropriate, have available laboratory facilities for the carrying out of simple diagnostic tests, post-mortem examinations, and/or the collection of samples that are to be subjected to more extensive laboratory investigations elsewhere. General and special purpose procedure rooms shall be available for situations where it is undesirable to carry out the procedures or observations in the holding rooms. |
| --- | --- | --- |

1.3.

(a)

Establishments shall, where appropriate, have available laboratory facilities for the carrying out of simple diagnostic tests, post-mortem examinations, and/or the collection of samples that are to be subjected to more extensive laboratory investigations elsewhere. General and special purpose procedure rooms shall be available for situations where it is undesirable to carry out the procedures or observations in the holding rooms.

| (b) | Facilities shall be provided to enable newly-acquired animals to be isolated until their health status can be determined and the potential health risk to established animals assessed and minimised. |
| --- | --- |

(b)

Facilities shall be provided to enable newly-acquired animals to be isolated until their health status can be determined and the potential health risk to established animals assessed and minimised.

| (c) | There shall be accommodation for the separate housing of sick or injured animals. |
| --- | --- |

(c)

There shall be accommodation for the separate housing of sick or injured animals.

| 1.4. | Service rooms






  (a) | Store-rooms shall be designed, used and maintained to safeguard the quality of food and bedding. These rooms shall be vermin and insect-proof, as far as possible. Other materials, which may be contaminated or present a hazard to animals or staff, shall be stored separately. |
| --- | --- | --- |

1.4.

(a)

Store-rooms shall be designed, used and maintained to safeguard the quality of food and bedding. These rooms shall be vermin and insect-proof, as far as possible. Other materials, which may be contaminated or present a hazard to animals or staff, shall be stored separately.

| (b) | The cleaning and washing areas shall be large enough to accommodate the installations necessary to decontaminate and clean used equipment. The cleaning process shall be arranged so as to separate the flow of clean and dirty equipment to prevent the contamination of newly-cleaned equipment. |
| --- | --- |

(b)

The cleaning and washing areas shall be large enough to accommodate the installations necessary to decontaminate and clean used equipment. The cleaning process shall be arranged so as to separate the flow of clean and dirty equipment to prevent the contamination of newly-cleaned equipment.

| (c) | Establishments shall provide for the hygienic storage and safe disposal of carcasses and animal waste. |
| --- | --- |

(c)

Establishments shall provide for the hygienic storage and safe disposal of carcasses and animal waste.

| (d) | Where surgical procedures under aseptic conditions are required there shall be provision for one or more than one suitably equipped room, and facilities provided for postoperative recovery. |
| --- | --- |

(d)

Where surgical procedures under aseptic conditions are required there shall be provision for one or more than one suitably equipped room, and facilities provided for postoperative recovery.

| 2. | The environment and control thereof |
| --- | --- |

2.

| 2.1. | Ventilation and temperature






  (a) | Insulation, heating and ventilation of the holding room shall ensure that the air circulation, dust levels, and gas concentrations are kept within limits that are not harmful to the animals housed. |
| --- | --- | --- |

2.1.

(a)

Insulation, heating and ventilation of the holding room shall ensure that the air circulation, dust levels, and gas concentrations are kept within limits that are not harmful to the animals housed.

| (b) | Temperature and relative humidity in the holding rooms shall be adapted to the species and age groups housed. The temperature shall be measured and logged on a daily basis. |
| --- | --- |

(b)

Temperature and relative humidity in the holding rooms shall be adapted to the species and age groups housed. The temperature shall be measured and logged on a daily basis.

| (c) | Animals shall not be restricted to outdoor areas under climatic conditions which may cause them distress. |
| --- | --- |

(c)

Animals shall not be restricted to outdoor areas under climatic conditions which may cause them distress.

| 2.2. | Lighting






  (a) | Where natural light does not provide an appropriate light/dark cycle, controlled lighting shall be provided to satisfy the biological requirements of the animals and to provide a satisfactory working environment. |
| --- | --- | --- |

2.2.

(a)

Where natural light does not provide an appropriate light/dark cycle, controlled lighting shall be provided to satisfy the biological requirements of the animals and to provide a satisfactory working environment.

| (b) | Illumination shall satisfy the needs for the performance of husbandry procedures and inspection of the animals. |
| --- | --- |

(b)

Illumination shall satisfy the needs for the performance of husbandry procedures and inspection of the animals.

| (c) | Regular photoperiods and intensity of light adapted to the species shall be provided. |
| --- | --- |

(c)

Regular photoperiods and intensity of light adapted to the species shall be provided.

| (d) | When keeping albino animals, the lighting shall be adjusted to take into account their sensitivity to light. |
| --- | --- |

(d)

When keeping albino animals, the lighting shall be adjusted to take into account their sensitivity to light.

| 2.3. | Noise






  (a) | Noise levels including ultrasound, shall not adversely affect animal welfare. |
| --- | --- | --- |

2.3.

(a)

Noise levels including ultrasound, shall not adversely affect animal welfare.

| (b) | Establishments shall have alarm systems that sound outside the sensitive hearing range of the animals, where this does not conflict with their audibility to human beings. |
| --- | --- |

(b)

Establishments shall have alarm systems that sound outside the sensitive hearing range of the animals, where this does not conflict with their audibility to human beings.

| (c) | Holding rooms shall where appropriate be provided with noise insulation and absorption materials. |
| --- | --- |

(c)

Holding rooms shall where appropriate be provided with noise insulation and absorption materials.

| 2.4. | Alarm systems






  (a) | Establishments relying on electrical or mechanical equipment for environmental control and protection, shall have a stand-by system to maintain essential services and emergency lighting systems as well as to ensure that alarm systems themselves do not fail to operate. |
| --- | --- | --- |

2.4.

(a)

Establishments relying on electrical or mechanical equipment for environmental control and protection, shall have a stand-by system to maintain essential services and emergency lighting systems as well as to ensure that alarm systems themselves do not fail to operate.

| (b) | Heating and ventilation systems shall be equipped with monitoring devices and alarms. |
| --- | --- |

(b)

Heating and ventilation systems shall be equipped with monitoring devices and alarms.

| (c) | Clear instructions on emergency procedures shall be prominently displayed. |
| --- | --- |

(c)

Clear instructions on emergency procedures shall be prominently displayed.

| 3. | Care of animals |
| --- | --- |

3.

| 3.1. | Health






  (a) | Establishments shall have a strategy in place to ensure that a health status of the animals is maintained that safeguards animal welfare and meets scientific requirements. This strategy shall include regular health monitoring, a microbiological surveillance programme and plans for dealing with health breakdowns and shall define health parameters and procedures for the introduction of new animals. |
| --- | --- | --- |

3.1.

(a)

Establishments shall have a strategy in place to ensure that a health status of the animals is maintained that safeguards animal welfare and meets scientific requirements. This strategy shall include regular health monitoring, a microbiological surveillance programme and plans for dealing with health breakdowns and shall define health parameters and procedures for the introduction of new animals.

| (b) | Animals shall be checked at least daily by a competent person. These checks shall ensure that all sick or injured animals are identified and appropriate action is taken. |
| --- | --- |

(b)

Animals shall be checked at least daily by a competent person. These checks shall ensure that all sick or injured animals are identified and appropriate action is taken.

| 3.2. | Animals taken from the wild






  (a) | Transport containers and means of transport adapted to the species concerned shall be available at capture sites, in case animals need to be moved for examination or treatment. |
| --- | --- | --- |

3.2.

(a)

Transport containers and means of transport adapted to the species concerned shall be available at capture sites, in case animals need to be moved for examination or treatment.

| (b) | Special consideration shall be given and appropriate measures taken for the acclimatisation, quarantine, housing, husbandry, care of animals taken from the wild and, as appropriate, provisions for setting them free at the end of procedures. |
| --- | --- |

(b)

Special consideration shall be given and appropriate measures taken for the acclimatisation, quarantine, housing, husbandry, care of animals taken from the wild and, as appropriate, provisions for setting them free at the end of procedures.

| 3.3. | Housing and enrichment






  (a) | Housing

  Animals, except those which are naturally solitary, shall be socially housed in stable groups of compatible individuals. In cases where single housing is allowed in accordance with article 33(3) the duration shall be limited to the minimum period necessary and visual, auditory, olfactory and/or tactile contact shall be maintained. The introduction or re-introduction of animals to established groups shall be carefully monitored to avoid problems of incompatibility and disrupted social relationships. |
| --- | --- | --- |

3.3.

(a)

Housing

Animals, except those which are naturally solitary, shall be socially housed in stable groups of compatible individuals. In cases where single housing is allowed in accordance with article 33(3) the duration shall be limited to the minimum period necessary and visual, auditory, olfactory and/or tactile contact shall be maintained. The introduction or re-introduction of animals to established groups shall be carefully monitored to avoid problems of incompatibility and disrupted social relationships.

| (b) | Enrichment

  All animals shall be provided with space of sufficient complexity to allow expression of a wide range of normal behaviour. They shall be given a degree of control and choice over their environment to reduce stress-induced behaviour. Establishments shall have appropriate enrichment techniques in place, to extend the range of activities available to the animals and increase their coping activities including physical exercise, foraging, manipulative and cognitive activities, as appropriate to the species. Environmental enrichment in animal enclosures shall be adapted to the species and individual needs of the animals concerned. The enrichment strategies in establishments shall be regularly reviewed and updated. |
| --- | --- |

(b)

Enrichment

All animals shall be provided with space of sufficient complexity to allow expression of a wide range of normal behaviour. They shall be given a degree of control and choice over their environment to reduce stress-induced behaviour. Establishments shall have appropriate enrichment techniques in place, to extend the range of activities available to the animals and increase their coping activities including physical exercise, foraging, manipulative and cognitive activities, as appropriate to the species. Environmental enrichment in animal enclosures shall be adapted to the species and individual needs of the animals concerned. The enrichment strategies in establishments shall be regularly reviewed and updated.

| (c) | Animal enclosures

  Animal enclosures shall not be made out of materials detrimental to the health of the animals. Their design and construction shall be such that no injury to the animals is caused. Unless they are disposable, they shall be made from materials that will withstand cleaning and decontamination techniques. The design of animal enclosure floors shall be adapted to the species and age of the animals and be designed to facilitate the removal of excreta. |
| --- | --- |

(c)

Animal enclosures

Animal enclosures shall not be made out of materials detrimental to the health of the animals. Their design and construction shall be such that no injury to the animals is caused. Unless they are disposable, they shall be made from materials that will withstand cleaning and decontamination techniques. The design of animal enclosure floors shall be adapted to the species and age of the animals and be designed to facilitate the removal of excreta.

| 3.4. | Feeding






  (a) | The form, content and presentation of the diet shall meet the nutritional and behavioural needs of the animal. |
| --- | --- | --- |

3.4.

(a)

The form, content and presentation of the diet shall meet the nutritional and behavioural needs of the animal.

| (b) | The animals' diet shall be palatable and non-contaminated. In the selection of raw materials, production, preparation and presentation of feed, establishments shall take measures to minimise chemical, physical and microbiological contamination. |
| --- | --- |

(b)

The animals' diet shall be palatable and non-contaminated. In the selection of raw materials, production, preparation and presentation of feed, establishments shall take measures to minimise chemical, physical and microbiological contamination.

| (c) | Packing, transport and storage shall be such as to avoid contamination, deterioration or destruction. All feed hoppers, troughs or other utensils used for feeding shall be regularly cleaned and, if necessary, sterilised. |
| --- | --- |

(c)

Packing, transport and storage shall be such as to avoid contamination, deterioration or destruction. All feed hoppers, troughs or other utensils used for feeding shall be regularly cleaned and, if necessary, sterilised.

| (d) | Each animal shall be able to access the food, with sufficient feeding space provided to limit competition. |
| --- | --- |

(d)

Each animal shall be able to access the food, with sufficient feeding space provided to limit competition.

| 3.5. | Watering






  (a) | Uncontaminated drinking water shall always be available to all animals. |
| --- | --- | --- |

3.5.

(a)

Uncontaminated drinking water shall always be available to all animals.

| (b) | When automatic watering systems are used, they shall be regularly checked, serviced and flushed to avoid accidents. If solid-bottomed cages are used, care shall be taken to minimise the risk of flooding. |
| --- | --- |

(b)

When automatic watering systems are used, they shall be regularly checked, serviced and flushed to avoid accidents. If solid-bottomed cages are used, care shall be taken to minimise the risk of flooding.

| (c) | Provision shall be made to adapt the water supply for aquaria and tanks to the needs and tolerance limits of the individual fish, amphibian and reptile species. |
| --- | --- |

(c)

Provision shall be made to adapt the water supply for aquaria and tanks to the needs and tolerance limits of the individual fish, amphibian and reptile species.

| 3.6. | Resting and sleeping areas






  (a) | Bedding materials or sleeping structures adapted to the species shall always be provided, including nesting materials or structures for breeding animals. |
| --- | --- | --- |

3.6.

(a)

Bedding materials or sleeping structures adapted to the species shall always be provided, including nesting materials or structures for breeding animals.

| (b) | Within the animal enclosure, as appropriate to the species, a solid, comfortable resting area for all animals shall be provided. All sleeping areas shall be kept clean and dry. |
| --- | --- |

(b)

Within the animal enclosure, as appropriate to the species, a solid, comfortable resting area for all animals shall be provided. All sleeping areas shall be kept clean and dry.

| 3.7. | Handling
  Establishments shall set up habituation and training programmes suitable for the animals, the procedures and length of the project. |
| --- | --- |

3.7.

Establishments shall set up habituation and training programmes suitable for the animals, the procedures and length of the project.

SECTION B: SPECIES-SPECIFIC SECTION

1.   Mice, rats, gerbils, hamsters and guinea pigs

In this and subsequent tables for mice, rats, gerbils, hamsters and guinea pigs, ‘enclosure height’ means the vertical distance between the enclosure floor and the top of the enclosure and this height applies over more than 50 % of the minimum enclosure floor area prior to the addition of enrichment devices.

When designing procedures, consideration shall be given to the potential growth of the animals to ensure adequate space is provided (as detailed in Tables 1.1. to 1.5) for the duration of the study.

Table 1.1. Mice

| | Body weight
  (g) | Minimum enclosure size
  (cm2) | Floor area per animal
  (cm2) | Minimum enclosure height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| In stock and during procedures | up to 20 | 330 | 60 | 12 | 1 January 2017 |
| over 20 to 25 | 330 | 70 | 12 |
| over 25 to 30 | 330 | 80 | 12 |
| over 30 | 330 | 100 | 12 |
| Breeding | | 330
  For a monogamous pair (outbred/inbred) or a trio (inbred). For each additional female plus litter 180 cm2 shall be added. | | 12 |
| Stock at breeders (1)

  Enclosure size
  950 cm2 | less than 20 | 950 | 40 | 12 |
| Enclosure size
  1 500 cm2 | less than 20 | 1 500 | 30 | 12 |

Body weight

(g)

Minimum enclosure size

(cm2)

Floor area per animal

(cm2)

Minimum enclosure height

(cm)

Date referred to in Article 33(2)

In stock and during procedures

up to 20

330

60

12

1 January 2017

over 20 to 25

330

70

12

over 25 to 30

330

80

12

over 30

330

100

12

Breeding

330

For a monogamous pair (outbred/inbred) or a trio (inbred). For each additional female plus litter 180 cm2 shall be added.

12

Stock at breeders (1)

Enclosure size

950 cm2

less than 20

950

40

12

Enclosure size

1 500 cm2

less than 20

1 500

30

12

Table 1.2. Rats

| | Body weight
  (g) | Minimum enclosure size
  (cm2) | Floor area per animal
  (cm2) | Minimum enclosure height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| In stock and during procedures (2) | up to 200 | 800 | 200 | 18 | 1 January 2017 |
| over 200 to 300 | 800 | 250 | 18 |
| over 300 to 400 | 800 | 350 | 18 |
| over 400 to 600 | 800 | 450 | 18 |
| over 600 | 1 500 | 600 | 18 |
| Breeding | | 800
  Mother and litter. For each additional adult animal permanently added to the enclosure add 400 cm2 | | 18 |
| Stock at breeders (3)

  Enclosure size 1 500 cm2 | up to 50 | 1 500 | 100 | 18 |
| over 50 to 100 | 1 500 | 125 | 18 |
| over 100 to 150 | 1 500 | 150 | 18 |
| over 150 to 200 | 1 500 | 175 | 18 |
| Stock at breeders (3)

  Enclosure size 2 500 cm2 | up to 100 | 2 500 | 100 | 18 |
| over 100 to 150 | 2 500 | 125 | 18 |
| over 150 to 200 | 2 500 | 150 | 18 |

Body weight

(g)

Minimum enclosure size

(cm2)

Floor area per animal

(cm2)

Minimum enclosure height

(cm)

Date referred to in Article 33(2)

In stock and during procedures (2)

up to 200

800

200

18

1 January 2017

over 200 to 300

800

250

18

over 300 to 400

800

350

18

over 400 to 600

800

450

18

over 600

1 500

600

18

Breeding

800

Mother and litter. For each additional adult animal permanently added to the enclosure add 400 cm2

18

Stock at breeders (3)

Enclosure size 1 500 cm2

up to 50

1 500

100

18

over 50 to 100

1 500

125

18

over 100 to 150

1 500

150

18

over 150 to 200

1 500

175

18

Stock at breeders (3)

Enclosure size 2 500 cm2

up to 100

2 500

100

18

over 100 to 150

2 500

125

18

over 150 to 200

2 500

150

18

Table 1.3. Gerbils

| | Body weight
  (g) | Minimum enclosure size
  (cm2) | Floor area per animal
  (cm2) | Minimum enclosure height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| In stock and during procedures | up to 40 | 1 200 | 150 | 18 | 1 January 2017 |
| over 40 | 1 200 | 250 | 18 |
| Breeding | | 1 200
  Monogamous pair or trio with offspring | | 18 |

Body weight

(g)

Minimum enclosure size

(cm2)

Floor area per animal

(cm2)

Minimum enclosure height

(cm)

Date referred to in Article 33(2)

In stock and during procedures

up to 40

1 200

150

18

1 January 2017

over 40

1 200

250

18

Breeding

1 200

Monogamous pair or trio with offspring

18

Table 1.4. Hamsters

| | Body weight
  (g) | Minimum enclosure size
  (cm2) | Floor area per animal
  (cm2) | Minimum enclosure height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| In stock and during procedures | up to 60 | 800 | 150 | 14 | 1 January 2017 |
| over 60 to 100 | 800 | 200 | 14 |
| over 100 | 800 | 250 | 14 |
| Breeding | | 800
  Mother or monogamous pair with litter | | 14 |
| Stock at breeders (4) | less than 60 | 1 500 | 100 | 14 |

Body weight

(g)

Minimum enclosure size

(cm2)

Floor area per animal

(cm2)

Minimum enclosure height

(cm)

Date referred to in Article 33(2)

In stock and during procedures

up to 60

800

150

14

1 January 2017

over 60 to 100

800

200

14

over 100

800

250

14

Breeding

800

Mother or monogamous pair with litter

14

Stock at breeders (4)

less than 60

1 500

100

14

Table 1.5. Guinea pigs

| | Body weight
  (g) | Minimum enclosure size
  (cm2) | Floor area per animal
  (cm2) | Minimum enclosure height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| In stock and during procedures | up to 200 | 1 800 | 200 | 23 | 1 January 2017 |
| over 200 to 300 | 1 800 | 350 | 23 |
| over 300 to 450 | 1 800 | 500 | 23 |
| over 450 to 700 | 2 500 | 700 | 23 |
| over 700 | 2 500 | 900 | 23 |
| Breeding | | 2 500
  Pair with litter. For each additional breeding female add 1 000 cm2 | | 23 |

Body weight

(g)

Minimum enclosure size

(cm2)

Floor area per animal

(cm2)

Minimum enclosure height

(cm)

Date referred to in Article 33(2)

In stock and during procedures

up to 200

1 800

200

23

1 January 2017

over 200 to 300

1 800

350

23

over 300 to 450

1 800

500

23

over 450 to 700

2 500

700

23

over 700

2 500

900

23

Breeding

2 500

Pair with litter. For each additional breeding female add 1 000 cm2

23

2.   Rabbits

During agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept, the keeping of the animals shall at least follow the standards laid down in Directive 98/58/EC (5).

A raised area shall be provided within the enclosure. This raised area must allow the animal to lie and sit and easily move underneath, and shall not cover more than 40 % of the floor space. When for scientific or veterinary reasons a raised area cannot be used, the enclosure shall be 33 % larger for a single rabbit and 60 % larger for two rabbits. Where a raised area is provided for rabbits of less than 10 weeks of age, the size of the raised area shall be at least of 55 cm by 25 cm and the height above the floor shall be such that the animals can make use of it.

Table 2.1. Rabbits over 10 weeks of age

Table 2.1 is to be used for both cages and pens. The additional floor area is as a minimum 3 000 cm2 per rabbit for the third, the fourth, the fifth and the sixth rabbit, while 2 500 cm2 as a minimum shall be added for each additional rabbit above a number of six.

| Final body weight (kg) | Minimum floor area for one or two socially harmonious animals
  (cm2) | Minimum height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- |
| Less than 3 | 3 500 | 45 | 1 January 2017 |
| From 3 to 5 | 4 200 | 45 |
| Over 5 | 5 400 | 60 |

Final body weight (kg)

Minimum floor area for one or two socially harmonious animals

(cm2)

Minimum height

(cm)

Date referred to in Article 33(2)

Less than 3

3 500

45

1 January 2017

From 3 to 5

4 200

45

Over 5

5 400

60

Table 2.2. Doe plus litter

| Doe weight
  (kg) | Minimum enclosure size
  (cm2) | Addition for nest boxes
  (cm2) | Minimum height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Less than 3 | 3 500 | 1 000 | 45 | 1 January 2017 |
| From 3 to 5 | 4 200 | 1 200 | 45 |
| Over 5 | 5 400 | 1 400 | 60 |

Doe weight

(kg)

Minimum enclosure size

(cm2)

Addition for nest boxes

(cm2)

Minimum height

(cm)

Date referred to in Article 33(2)

Less than 3

3 500

1 000

45

1 January 2017

From 3 to 5

4 200

1 200

45

Over 5

5 400

1 400

60

Table 2.3. Rabbits less than 10 weeks of age

Table 2.3 is to be used for both cages and pens.

| Age | Minimum enclosure size
  (cm2) | Minimum floor area per animal
  (cm2) | Minimum height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Weaning to 7 weeks | 4 000 | 800 | 40 | 1 January 2017 |
| From 7 to 10 weeks | 4 000 | 1 200 | 40 |

Age

Minimum enclosure size

(cm2)

Minimum floor area per animal

(cm2)

Minimum height

(cm)

Date referred to in Article 33(2)

Weaning to 7 weeks

4 000

800

40

1 January 2017

From 7 to 10 weeks

4 000

1 200

40

Table 2.4. Rabbits: Optimal dimensions for raised areas for enclosures having the dimensions indicated in Table 2.1.

| Age in weeks | Final body weight
  (kg) | Optimum size
  (cm × cm) | Optimum height from the enclosure floor
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Over 10 | Less than 3 | 55 × 25 | 25 | 1 January 2017 |
| From 3 to 5 | 55 × 30 | 25 |
| Over 5 | 60 × 35 | 30 |

Age in weeks

Final body weight

(kg)

Optimum size

(cm × cm)

Optimum height from the enclosure floor

(cm)

Date referred to in Article 33(2)

Over 10

Less than 3

55 × 25

25

1 January 2017

From 3 to 5

55 × 30

25

Over 5

60 × 35

30

3.   Cats

Cats shall not be single-housed for more than twenty-four hours at a time. Cats that are repeatedly aggressive towards other cats shall be housed singly only if a compatible companion cannot be found. Social stress in all pair- or group-housed individuals shall be monitored at least weekly. Females with kittens under four weeks of age or in the last two weeks of pregnancy may be housed singly.

Table 3. Cats

The minimum space in which a queen and litter may be held is the space for a single cat, which shall be gradually increased so that by four months of age litters have been rehoused following the space requirements for adults.

Areas for feeding and for litter trays shall not be less than 0,5 metres apart and shall not be interchanged.

| | Floor (6)

  (m2) | Shelves
  (m2) | Height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Minimum for one adult animal | 1,5 | 0,5 | 2 | 1 January 2017 |
| For each additional animal add | 0,75 | 0,25 | — |

Floor (6)

(m2)

Shelves

(m2)

Height

(m)

Date referred to in Article 33(2)

Minimum for one adult animal

1,5

0,5

2

1 January 2017

For each additional animal add

0,75

0,25

—

4.   Dogs

Dogs shall where possible be provided with outside runs. Dogs shall not be single-housed for more than four hours at a time.

The internal enclosure shall represent at least 50 % of the minimum space to be made available to the dogs, as detailed in Table 4.1.

The space allowances detailed below are based on the requirements of beagles, but giant breeds such as St Bernards or Irish wolfhounds shall be provided with allowances significantly in excess of those detailed in Table 4.1. For breeds other than the laboratory beagle, space allowances shall be determined in consultation with veterinary staff.

Table 4.1. Dogs

Dogs that are pair or group housed may each be constrained to half the total space provided (2 m2 for a dog under 20 kg, 4 m2 for a dog over 20 kg) while they are undergoing procedures as defined in this Directive, if this separation is essential for scientific purposes. The period for which a dog is so constrained shall not exceed four hours at a time.

A nursing bitch and litter shall have the same space allowance as a single bitch of equivalent weight. The whelping pen shall be designed so that the bitch can move to an additional compartment or raised area away from the puppies.

| Weight
  (kg) | Minimum enclosure size
  (m2) | Minimum floor area for one or two animals
  (m2) | For each additional animal add a minimum of
  (m2) | Minimum height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 20 | 4 | 4 | 2 | 2 | 1 January 2017 |
| Over 20 | 8 | 8 | 4 | 2 |

Weight

(kg)

Minimum enclosure size

(m2)

Minimum floor area for one or two animals

(m2)

For each additional animal add a minimum of

(m2)

Minimum height

(m)

Date referred to in Article 33(2)

Up to 20

4

4

2

2

1 January 2017

Over 20

8

8

4

2

Table 4.2. Dogs - post-weaned stock

| Weight of dog
  (kg) | Minimum enclosure size
  (m2) | Minimum floor area/animal
  (m2) | Minimum height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 5 | 4 | 0,5 | 2 | 1 January 2017 |
| Over 5 to 10 | 4 | 1,0 | 2 |
| Over 10 to 15 | 4 | 1,5 | 2 |
| Over 15 to 20 | 4 | 2 | 2 |
| Over 20 | 8 | 4 | 2 |

Weight of dog

(kg)

Minimum enclosure size

(m2)

Minimum floor area/animal

(m2)

Minimum height

(m)

Date referred to in Article 33(2)

Up to 5

4

0,5

2

1 January 2017

Over 5 to 10

4

1,0

2

Over 10 to 15

4

1,5

2

Over 15 to 20

4

2

2

Over 20

8

4

2

5.   Ferrets

Table 5. Ferrets

| | Minimum enclosure size
  (cm2) | Minimum floor area per animal
  (cm2) | Minimum height
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Animals up to 600 g | 4 500 | 1 500 | 50 | 1 January 2017 |
| Animals over 600 g | 4 500 | 3 000 | 50 |
| Adult males | 6 000 | 6 000 | 50 |
| Jill and litter | 5 400 | 5 400 | 50 |

Minimum enclosure size

(cm2)

Minimum floor area per animal

(cm2)

Minimum height

(cm)

Date referred to in Article 33(2)

Animals up to 600 g

4 500

1 500

50

1 January 2017

Animals over 600 g

4 500

3 000

50

Adult males

6 000

6 000

50

Jill and litter

5 400

5 400

50

6.   Non-human primates

Young non-human primates shall not be separated from their mothers until they are, depending on the species, 6 to 12 months old.

The environment shall enable non-human primates to carry out a complex daily programme of activity. The enclosure shall allow non-human primates to adopt as wide a behavioural repertoire as possible, provide it with a sense of security, and a suitably complex environment to allow the animal to run, walk, climb and jump.

Table 6.1. Marmosets and tamarins

| | Minimum floor area of enclosures for 1 (7) or 2 animals plus offspring up to 5 months old
  (m2) | Minimum volume per additional animal over 5 months
  (m 3) | Minimum enclosure height
  (m) (8) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Marmosets | 0,5 | 0,2 | 1,5 | 1 January 2017 |
| Tamarins | 1,5 | 0,2 | 1,5 |

Minimum floor area of enclosures for 1 (7) or 2 animals plus offspring up to 5 months old

(m2)

Minimum volume per additional animal over 5 months

(m 3)

Minimum enclosure height

(m) (8)

Date referred to in Article 33(2)

Marmosets

0,5

0,2

1,5

1 January 2017

Tamarins

1,5

0,2

1,5

For marmosets and tamarins, separation from the mother shall not take place before 8 months of age.

Table 6.2. Squirrel monkeys

| Minimum floor area for 1 (9) or 2 animals
  (m2) | Minimum volume per additional animal over 6 months of age
  (m3) | Minimum enclosure height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- |
| 2,0 | 0,5 | 1,8 | 1 January 2017 |

Minimum floor area for 1 (9) or 2 animals

(m2)

Minimum volume per additional animal over 6 months of age

(m3)

Minimum enclosure height

(m)

Date referred to in Article 33(2)

2,0

0,5

1,8

1 January 2017

For squirrel monkeys, separation from the mother shall not take place before 6 months of age.

Table 6.3. Macaques and vervets (10)

| | Minimum enclosure size
  (m2) | Minimum enclosure volume
  (m3) | Minimum volume per animal
  (m3) | Minimum enclosure height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Animals less than 3 years of age (11) | 2,0 | 3,6 | 1,0 | 1,8 | 1 January 2017 |
| Animals from 3 years of age (12) | 2,0 | 3,6 | 1,8 | 1,8 |
| Animals held for breeding purposes (13) | | | 3,5 | 2,0 |

Minimum enclosure size

(m2)

Minimum enclosure volume

(m3)

Minimum volume per animal

(m3)

Minimum enclosure height

(m)

Date referred to in Article 33(2)

Animals less than 3 years of age (11)

2,0

3,6

1,0

1,8

1 January 2017

Animals from 3 years of age (12)

2,0

3,6

1,8

1,8

Animals held for breeding purposes (13)

3,5

2,0

For macaques and vervets, separation from the mother shall not take place before 8 months of age.

Table 6.4. Baboons (14)

| | Minimum enclosure size
  (m2) | Minimum enclosure volume
  (m3) | Minimum volume per animal
  (m3) | Minimum enclosure height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Animals less than 4 years of age (15) | 4,0 | 7,2 | 3,0 | 1,8 | 1 January 2017 |
| Animals from 4 years of age (15) | 7,0 | 12,6 | 6,0 | 1,8 |
| Animals held for breeding purposes (16) | | | 12,0 | 2,0 |

Minimum enclosure size

(m2)

Minimum enclosure volume

(m3)

Minimum volume per animal

(m3)

Minimum enclosure height

(m)

Date referred to in Article 33(2)

Animals less than 4 years of age (15)

4,0

7,2

3,0

1,8

1 January 2017

Animals from 4 years of age (15)

7,0

12,6

6,0

1,8

Animals held for breeding purposes (16)

12,0

2,0

For baboons, separation from the mother shall not take place before 8 months of age.

7.   Farm animals

During agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept, the keeping of the animals shall comply at least with the standards laid down in Directives 98/58/EC, 91/629/EEC (17) and 91/630/EEC (18).

Table 7.1. Cattle

| Body weight
  (kg) | Minimum enclosure size
  (m2) | Minimum floor area/animal
  (m2/animal) | Trough space for ad-libitum feeding of polled cattle
  (m/animal) | Trough space for restricted feeding of polled cattle
  (m/animal) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 100 | 2,50 | 2,30 | 0,10 | 0,30 | 1 January 2017 |
| Over 100 to 200 | 4,25 | 3,40 | 0,15 | 0,50 |
| Over 200 to 400 | 6,00 | 4,80 | 0,18 | 0,60 |
| Over 400 to 600 | 9,00 | 7,50 | 0,21 | 0,70 |
| Over 600 to 800 | 11,00 | 8,75 | 0,24 | 0,80 |
| Over 800 | 16,00 | 10,00 | 0,30 | 1,00 |

Body weight

(kg)

Minimum enclosure size

(m2)

Minimum floor area/animal

(m2/animal)

Trough space for ad-libitum feeding of polled cattle

(m/animal)

Trough space for restricted feeding of polled cattle

(m/animal)

Date referred to in Article 33(2)

Up to 100

2,50

2,30

0,10

0,30

1 January 2017

Over 100 to 200

4,25

3,40

0,15

0,50

Over 200 to 400

6,00

4,80

0,18

0,60

Over 400 to 600

9,00

7,50

0,21

0,70

Over 600 to 800

11,00

8,75

0,24

0,80

Over 800

16,00

10,00

0,30

1,00

Table 7.2. Sheep and goats

| Body weight
  (kg) | Minimum enclosure size
  (m2) | Minimum floor area/animal
  (m2/animal) | Minimum partition height
  (m) | Trough space for ad-libitum feeding
  (m/animal) | Trough space for restricted feeding
  (m/animal) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- | --- |
| Less than 20 | 1,0 | 0,7 | 1,0 | 0,10 | 0,25 | 1 January 2017 |
| Over 20 to 35 | 1,5 | 1,0 | 1,2 | 0,10 | 0,30 |
| Over 35 to 60 | 2,0 | 1,5 | 1,2 | 0,12 | 0,40 |
| Over 60 | 3,0 | 1,8 | 1,5 | 0,12 | 0,50 |

Body weight

(kg)

Minimum enclosure size

(m2)

Minimum floor area/animal

(m2/animal)

Minimum partition height

(m)

Trough space for ad-libitum feeding

(m/animal)

Trough space for restricted feeding

(m/animal)

Date referred to in Article 33(2)

Less than 20

1,0

0,7

1,0

0,10

0,25

1 January 2017

Over 20 to 35

1,5

1,0

1,2

0,10

0,30

Over 35 to 60

2,0

1,5

1,2

0,12

0,40

Over 60

3,0

1,8

1,5

0,12

0,50

Table 7.3. Pigs and minipigs

| Live weight
  (kg) | Minimum enclosure size (19)

  (m2) | Minimum floor area per animal
  (m2/animal) | Minimum lying space per animal (in, thermoneutral conditions)
  (m2/animal) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 5 | 2,0 | 0,20 | 0,10 | 1 January 2017 |
| Over 5 to 10 | 2,0 | 0,25 | 0,11 |
| Over 10 to 20 | 2,0 | 0,35 | 0,18 |
| Over 20 to 30 | 2,0 | 0,50 | 0,24 |
| Over 30 to 50 | 2,0 | 0,70 | 0,33 |
| Over 50 to 70 | 3,0 | 0,80 | 0,41 |
| Over 70 to 100 | 3,0 | 1,00 | 0,53 |
| Over 100 to 150 | 4,0 | 1,35 | 0,70 |
| Over 150 | 5,0 | 2,50 | 0,95 |
| Adult (conventional) boars | 7,5 | | 1,30 |

Live weight

(kg)

Minimum enclosure size (19)

(m2)

Minimum floor area per animal

(m2/animal)

Minimum lying space per animal (in, thermoneutral conditions)

(m2/animal)

Date referred to in Article 33(2)

Up to 5

2,0

0,20

0,10

1 January 2017

Over 5 to 10

2,0

0,25

0,11

Over 10 to 20

2,0

0,35

0,18

Over 20 to 30

2,0

0,50

0,24

Over 30 to 50

2,0

0,70

0,33

Over 50 to 70

3,0

0,80

0,41

Over 70 to 100

3,0

1,00

0,53

Over 100 to 150

4,0

1,35

0,70

Over 150

5,0

2,50

0,95

Adult (conventional) boars

7,5

1,30

Table 7.4. Equines

The shortest side shall be a minimum of 1,5 times the wither height of the animal. The height of indoor enclosures shall allow animals to rear to their full height.

| Wither height
  (m) | Minimum floor area/animal
  (m2/animal) | Minimum enclosure height
  (m) | Date referred to in Article 33(2) |
| --- | --- | --- | --- |
| For each animal held singly or in groups of up to 3 animals | For each animal held in groups of 4 or more animals | Foaling box / mare with foal |
| 1,00 to 1,40 | 9,0 | 6,0 | 16 | 3,00 | 1 January 2017 |
| Over 1,40 to 1,60 | 12,0 | 9,0 | 20 | 3,00 |
| Over 1,60 | 16,0 | (2 × WH)2
   (20) | 20 | 3,00 |

Wither height

(m)

Minimum floor area/animal

(m2/animal)

Minimum enclosure height

(m)

Date referred to in Article 33(2)

For each animal held singly or in groups of up to 3 animals

For each animal held in groups of 4 or more animals

Foaling box / mare with foal

1,00 to 1,40

9,0

6,0

16

3,00

1 January 2017

Over 1,40 to 1,60

12,0

9,0

20

3,00

Over 1,60

16,0

(2 × WH)2
   (20)

20

3,00

8.   Birds

During agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept, the keeping of the animals shall comply at least with the standards laid down in Directives 98/58/EC, 1999/74/EC (21) and 2007/43/EC (22).

Table 8.1. Domestic fowl

Where these minimum enclosure sizes cannot be provided for scientific reasons, the duration of the confinement shall be justified by the experimenter in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a minimum floor area of 0,75 m2.

| Body mass
  (g) | Minimum enclosure size
  (m2) | Minimum area per bird
  (m2) | Minimum height
  (cm) | Minimum length of feed trough per bird
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 200 | 1,00 | 0,025 | 30 | 3 | 1 January 2017 |
| Over 200 to 300 | 1,00 | 0,03 | 30 | 3 |
| Over 300 to 600 | 1,00 | 0,05 | 40 | 7 |
| Over 600 to 1 200 | 2,00 | 0,09 | 50 | 15 |
| Over 1 200 To 1 800 | 2,00 | 0,11 | 75 | 15 |
| Over 1 800 To 2 400 | 2,00 | 0,13 | 75 | 15 |
| Over 2 400 | 2,00 | 0,21 | 75 | 15 |

Body mass

(g)

Minimum enclosure size

(m2)

Minimum area per bird

(m2)

Minimum height

(cm)

Minimum length of feed trough per bird

(cm)

Date referred to in Article 33(2)

Up to 200

1,00

0,025

30

3

1 January 2017

Over 200 to 300

1,00

0,03

30

3

Over 300 to 600

1,00

0,05

40

7

Over 600 to 1 200

2,00

0,09

50

15

Over 1 200 To 1 800

2,00

0,11

75

15

Over 1 800 To 2 400

2,00

0,13

75

15

Over 2 400

2,00

0,21

75

15

Table 8.2. Domestic turkeys

All enclosure sides shall be at least 1,5 m long. Where these minimum enclosures sizes cannot be provided for scientific reasons, the duration of the confinement shall be justified by the experimenter in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a minimum floor area of 0,75 m2 and a minimum height of 50 cm for birds below 0,6 kg, 75 cm for birds below 4 kg, and 100 cm for birds over 4 kg. These can be used to house small groups of birds in accordance with the space allowances given in table 8.2.

| Body mass
  (kg) | Minimum enclosure size
  (m2) | Minimum area per bird
  (m2) | Minimum height
  (cm) | Minimum length of feed trough per bird
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 0,3 | 2,00 | 0,13 | 50 | 3 | 1 January 2017 |
| Over 0,3 to 0,6 | 2,00 | 0,17 | 50 | 7 |
| Over 0,6 to 1 | 2,00 | 0,30 | 100 | 15 |
| Over 1 to 4 | 2,00 | 0,35 | 100 | 15 |
| Over 4 to 8 | 2,00 | 0,40 | 100 | 15 |
| Over 8 to 12 | 2,00 | 0,50 | 150 | 20 |
| Over 12 to 16 | 2,00 | 0,55 | 150 | 20 |
| Over 16 to 20 | 2,00 | 0,60 | 150 | 20 |
| Over 20 | 3,00 | 1,00 | 150 | 20 |

Body mass

(kg)

Minimum enclosure size

(m2)

Minimum area per bird

(m2)

Minimum height

(cm)

Minimum length of feed trough per bird

(cm)

Date referred to in Article 33(2)

Up to 0,3

2,00

0,13

50

3

1 January 2017

Over 0,3 to 0,6

2,00

0,17

50

7

Over 0,6 to 1

2,00

0,30

100

15

Over 1 to 4

2,00

0,35

100

15

Over 4 to 8

2,00

0,40

100

15

Over 8 to 12

2,00

0,50

150

20

Over 12 to 16

2,00

0,55

150

20

Over 16 to 20

2,00

0,60

150

20

Over 20

3,00

1,00

150

20

Table 8.3. Quails

| Body mass
  (g) | Minimum enclosure size
  (m2) | Area per bird pair-housed
  (m2) | Area per additional bird group-housed
  (m2) | Minimum height
  (cm) | Minimum length of trough per bird
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- | --- |
| Up to 150 | 1,00 | 0,5 | 0,10 | 20 | 4 | 1 January 2017 |
| Over 150 | 1,00 | 0,6 | 0,15 | 30 | 4 |

Body mass

(g)

Minimum enclosure size

(m2)

Area per bird pair-housed

(m2)

Area per additional bird group-housed

(m2)

Minimum height

(cm)

Minimum length of trough per bird

(cm)

Date referred to in Article 33(2)

Up to 150

1,00

0,5

0,10

20

4

1 January 2017

Over 150

1,00

0,6

0,15

30

4

Table 8.4. Ducks and geese

Where these minimum enclosures sizes cannot be provided for scientific reasons, the duration of the confinement shall be justified by the experimenter in consultation with veterinary staff. In such circumstances, birds can be housed in smaller enclosures containing appropriate enrichment and with a minimum floor area of 0,75 m2. These can be used to house small groups of birds in accordance with the space allowances given in table 8.4.

| Body mass
  (g) | Minimum enclosure size
  (m2) | Area per bird
  (m2) (23) | Minimum height
  (cm) | Minimum length of feed trough per bird
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Ducks | 1 January 2017 |
| Up to 300 | 2,00 | 0,10 | 50 | 10 |
| Over 300 to 1 200 (24) | 2,00 | 0,20 | 200 | 10 |
| Over 1 200 to 3 500 | 2,00 | 0,25 | 200 | 15 |
| Over 3 500 | 2,00 | 0,50 | 200 | 15 |
| Geese |
| Up to 500 | 2,00 | 0,20 | 200 | 10 |
| Over 500 to 2 000 | 2,00 | 0,33 | 200 | 15 |
| Over 2 000 | 2,00 | 0,50 | 200 | 15 |

Body mass

(g)

Minimum enclosure size

(m2)

Area per bird

(m2) (23)

Minimum height

(cm)

Minimum length of feed trough per bird

(cm)

Date referred to in Article 33(2)

Ducks

1 January 2017

Up to 300

2,00

0,10

50

10

Over 300 to 1 200 (24)

2,00

0,20

200

10

Over 1 200 to 3 500

2,00

0,25

200

15

Over 3 500

2,00

0,50

200

15

Geese

Up to 500

2,00

0,20

200

10

Over 500 to 2 000

2,00

0,33

200

15

Over 2 000

2,00

0,50

200

15

Table 8.5. Ducks and geese: Minimum pond sizes (25)

| | Area
  (m2) | Depth
  (cm) |
| --- | --- | --- |
| Ducks | 0,5 | 30 |
| Geese | 0,5 | from 10 to 30 |

Area

(m2)

Depth

(cm)

Ducks

0,5

30

Geese

0,5

from 10 to 30

Table 8.6. Pigeons

Enclosures shall be long and narrow (for example 2 m by 1 m) rather than square to allow birds to perform short flights.

| Group size | Minimum enclosure size
  (m2) | Minimum height
  (cm) | Minimum length of food trough per bird
  (cm) | Minimum length of perch per bird
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 6 | 2 | 200 | 5 | 30 | 1 January 2017 |
| From 7 to 12 | 3 | 200 | 5 | 30 |
| For each additional bird above 12 | 0,15 | | 5 | 30 |

Group size

Minimum enclosure size

(m2)

Minimum height

(cm)

Minimum length of food trough per bird

(cm)

Minimum length of perch per bird

(cm)

Date referred to in Article 33(2)

Up to 6

2

200

5

30

1 January 2017

From 7 to 12

3

200

5

30

For each additional bird above 12

0,15

5

30

Table 8.7. Zebra finches

Enclosures shall be long and narrow (for example 2 m by 1 m) to enable birds to perform short flights. For breeding studies, pairs may be housed in smaller enclosures containing appropriate enrichment with a minimum floor area of 0,5 m2 and a minimum height of 40 cm. The duration of the confinement shall be justified by the experimenter in consultation with veterinary staff.

| Group size | Minimum enclosure size
  (m2) | Minimum height
  (cm) | Minimum number of feeders | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 6 | 1,0 | 100 | 2 | 1 January 2017 |
| 7 to 12 | 1,5 | 200 | 2 |
| 13 to 20 | 2,0 | 200 | 3 |
| For each additional bird above 20 | 0,05 | | 1 per 6 birds |

Group size

Minimum enclosure size

(m2)

Minimum height

(cm)

Minimum number of feeders

Date referred to in Article 33(2)

Up to 6

1,0

100

2

1 January 2017

7 to 12

1,5

200

2

13 to 20

2,0

200

3

For each additional bird above 20

0,05

1 per 6 birds

9.   Amphibians

Table 9.1. Aquatic urodeles

| Body length (26)

  (cm) | Minimum water surface area
  (cm2) | Minimum water surface area for each additional animal in group-holding
  (cm2) | Minimum water depth
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 10 | 262,5 | 50 | 13 | 1 January 2017 |
| Over 10 to 15 | 525 | 110 | 13 |
| Over 15 to 20 | 875 | 200 | 15 |
| Over 20 to 30 | 1 837,5 | 440 | 15 |
| Over 30 | 3 150 | 800 | 20 |

Body length (26)

(cm)

Minimum water surface area

(cm2)

Minimum water surface area for each additional animal in group-holding

(cm2)

Minimum water depth

(cm)

Date referred to in Article 33(2)

Up to 10

262,5

50

13

1 January 2017

Over 10 to 15

525

110

13

Over 15 to 20

875

200

15

Over 20 to 30

1 837,5

440

15

Over 30

3 150

800

20

Table 9.2. Aquatic anurans (27)

| Body length (28)

  (cm) | Minimum water surface area
  (cm2) | Minimum water surface area for each additional animal in group-holding
  (cm2) | Minimum water depth
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Less than 6 | 160 | 40 | 6 | 1 January 2017 |
| From 6 to 9 | 300 | 75 | 8 |
| Over 9 to 12 | 600 | 150 | 10 |
| Over 12 | 920 | 230 | 12,5 |

Body length (28)

(cm)

Minimum water surface area

(cm2)

Minimum water surface area for each additional animal in group-holding

(cm2)

Minimum water depth

(cm)

Date referred to in Article 33(2)

Less than 6

160

40

6

1 January 2017

From 6 to 9

300

75

8

Over 9 to 12

600

150

10

Over 12

920

230

12,5

Table 9.3. Semi-aquatic anurans

| Body length (29)

  (cm) | Minimum enclosure size (30)

  (cm2) | Minimum area for each additional animal in group holding
  (cm2) | Minimum enclosure height (31)

  (cm) | Minimum water depth
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 5.0 | 1 500 | 200 | 20 | 10 | 1 January 2017 |
| Over 5,0 to 7,5 | 3 500 | 500 | 30 | 10 |
| Over 7,5 | 4 000 | 700 | 30 | 15 |

Body length (29)

(cm)

Minimum enclosure size (30)

(cm2)

Minimum area for each additional animal in group holding

(cm2)

Minimum enclosure height (31)

(cm)

Minimum water depth

(cm)

Date referred to in Article 33(2)

Up to 5.0

1 500

200

20

10

1 January 2017

Over 5,0 to 7,5

3 500

500

30

10

Over 7,5

4 000

700

30

15

Table 9.4. Semi-terrestrial anurans

| Body length (32)

  (cm) | Minimum enclosure size (33)

  (cm2) | Minimum area for each additional animal in group-holding
  (cm2) | Minimum enclosure height (34)

  (cm) | Minimum water depth
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- | --- |
| Up to 5,0 | 1 500 | 200 | 20 | 10 | 1 January 2017 |
| Over 5,0 to 7,5 | 3 500 | 500 | 30 | 10 |
| Over 7,5 | 4 000 | 700 | 30 | 15 |

Body length (32)

(cm)

Minimum enclosure size (33)

(cm2)

Minimum area for each additional animal in group-holding

(cm2)

Minimum enclosure height (34)

(cm)

Minimum water depth

(cm)

Date referred to in Article 33(2)

Up to 5,0

1 500

200

20

10

1 January 2017

Over 5,0 to 7,5

3 500

500

30

10

Over 7,5

4 000

700

30

15

Table 9.5. Arboreal anurans

| Body length (35)

  (cm) | Minimum enclosure size (36)

  (cm2) | Minimum area for each additional animal in group-holding
  (cm2) | Minimum enclosure height (37)

  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 3,0 | 900 | 100 | 30 | 1 January 2017 |
| Over 3,0 | 1 500 | 200 | 30 |

Body length (35)

(cm)

Minimum enclosure size (36)

(cm2)

Minimum area for each additional animal in group-holding

(cm2)

Minimum enclosure height (37)

(cm)

Date referred to in Article 33(2)

Up to 3,0

900

100

30

1 January 2017

Over 3,0

1 500

200

30

10.   Reptiles

Table 10.1. Aquatic chelonians

| Body length (38)

  (cm) | Minimum water surface area
  (cm2) | Minimum water surface area for each additional animal in group holding
  (cm2) | Minimum water depth
  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 5 | 600 | 100 | 10 | 1 January 2017 |
| Over 5 to 10 | 1 600 | 300 | 15 |
| Over 10 to 15 | 3 500 | 600 | 20 |
| Over 15 to 20 | 6 000 | 1 200 | 30 |
| Over 20 to 30 | 10 000 | 2 000 | 35 |
| Over 30 | 20 000 | 5 000 | 40 |

Body length (38)

(cm)

Minimum water surface area

(cm2)

Minimum water surface area for each additional animal in group holding

(cm2)

Minimum water depth

(cm)

Date referred to in Article 33(2)

Up to 5

600

100

10

1 January 2017

Over 5 to 10

1 600

300

15

Over 10 to 15

3 500

600

20

Over 15 to 20

6 000

1 200

30

Over 20 to 30

10 000

2 000

35

Over 30

20 000

5 000

40

Table 10.2. Terrestrial snakes

| Body length (39)

  (cm) | Minimum floor area
  (cm2) | Minimum area for each additional animal in group-holding
  (cm2) | Minimum enclosure height (40)

  (cm) | Date referred to in Article 33(2) |
| --- | --- | --- | --- | --- |
| Up to 30 | 300 | 150 | 10 | 1 January 2017 |
| Over 30 to 40 | 400 | 200 | 12 |
| Over 40 to 50 | 600 | 300 | 15 |
| Over 50 to 75 | 1 200 | 600 | 20 |
| Over 75 | 2 500 | 1 200 | 28 |

Body length (39)

(cm)

Minimum floor area

(cm2)

Minimum area for each additional animal in group-holding

(cm2)

Minimum enclosure height (40)

(cm)

Date referred to in Article 33(2)

Up to 30

300

150

10

1 January 2017

Over 30 to 40

400

200

12

Over 40 to 50

600

300

15

Over 50 to 75

1 200

600

20

Over 75

2 500

1 200

28

11.   Fish

11.1.   Water supply and quality

Adequate water supply of suitable quality shall be provided at all times. Water flow in re-circulatory systems or filtration within tanks shall be sufficient to ensure that water quality parameters are maintained within acceptable levels. Water supply shall be filtered or treated to remove substances harmful to fish, where necessary. Water-quality parameters shall at all times be within the acceptable range that sustains normal activity and physiology for a given species and stage of development. The water flow shall be appropriate to enable fish to swim correctly and to maintain normal behaviour. Fish shall be given an appropriate time for acclimatisation and adaptation to changes in water-quality conditions.

11.2.   Oxygen, nitrogen compounds, pH, and salinity

Oxygen concentration shall be appropriate to the species and to the context in which the fish are held. Where necessary, supplementary aeration of tank water shall be provided. The concentrations of nitrogen compounds shall be kept low.

The pH level shall be adapted to the species and kept as stable as possible. The salinity shall be adapted to the requirements of the fish species and to the life stage of the fish. Changes in salinity shall take place gradually.

11.3.   Temperature, lighting, noise

Temperature shall be maintained within the optimal range for the fish species concerned and kept as stable as possible. Changes in temperature shall take place gradually. Fish shall be maintained on an appropriate photoperiod. Noise levels shall be kept to a minimum and, where possible, equipment causing noise or vibration, such as power generators or filtration systems, shall be separate from the fish-holding tanks.

11.4.   Stocking density and environmental complexity

The stocking density of fish shall be based on the total needs of the fish in respect of environmental conditions, health and welfare. Fish shall have sufficient water volume for normal swimming, taking account of their size, age, health and feeding method. Fish shall be provided with an appropriate environmental enrichment, such as hiding places or bottom substrate, unless behavioural traits suggest none is required.

11.5.   Feeding and handling

Fish shall be fed a diet suitable for the fish at an appropriate feeding rate and frequency. Particular attention shall be given to feeding of larval fish during any transition from live to artificial diets. Handling of fish shall be kept to a minimum.

---

(1)  Post-weaned mice may be kept at these higher stocking densities for the short period after weaning until issue, provided that the animals are housed in larger enclosures with adequate enrichment, and these housing conditions do not cause any welfare deficit such as increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or other physiological or behavioural stress responses.

(2)  In long-term studies, if space allowances per individual animal fall below those indicated above towards the end of such studies, priority shall be given to maintaining stable social structures.

(3)  Post-weaned rats may be kept at these higher stocking densities for the short period after weaning until issue, provided that the animals are housed in larger enclosures with adequate enrichment, and these housing conditions do not cause any welfare deficit such as increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or other physiological or behavioural stress responses.

(4)  Post-weaned hamsters may be kept at these higher stocking densities, for the short period after weaning until issue provided that the animals are housed in larger enclosures with adequate enrichment, and these housing conditions do not cause any welfare deficit such as increased levels of aggression, morbidity or mortality, stereotypes and other behavioural deficits, weight loss, or other physiological or behavioural stress responses.

(5)  Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23).

(6)  Floor area excluding shelves.

(7)  Animals shall be kept singly only in exceptional circumstances.

(8)  The top of the enclosure shall be at least 1,8m from the floor.

(9)  Animals shall be kept singly only in exceptional circumstances.

(10)  Animals shall be kept singly only in exceptional circumstances.

(11)  An enclosure of minimum dimensions may hold up to three animals.

(12)  An enclosure of minimum dimensions may hold up to two animals.

(13)  In breeding colonies no additional space/volume allowance is required for young animals up to 2 years of age housed with their mother.

(14)  Animals shall be kept singly only in exceptional circumstances.

(15)  An enclosure of minimum dimensions may hold up to 2 animals.

(16)  In breeding colonies no additional space/volume allowance is required for young animals up to 2 years of age housed with their mothers.

(17)  Council Directive 91/629/EEC of 19 November 1991 laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28).

(18)  Council Directive 91/630/EEC of 19 November 1991 laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33).

(19)  Pigs may be confined in smaller enclosures for short periods of time, for example by partitioning the main enclosure using dividers, when justified on veterinary or experimental grounds, for example where individual food consumption is required.

(20)  To ensure adequate space is provided, space allowances for each individual animal shall be based on height to withers (WH).

(21)  Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53).

(22)  Council Directive 2007/43/EC of 28 June 2007 laying down minimum rules for the protection of chickens kept for meat production (OJ L 182, 12.7.2007, p. 19).

(23)  This shall include a pond of minimum area 0,5 m2 per 2 m2 enclosure with a minimum depth of 30 cm. The pond may contribute up to 50 % of the minimum enclosure size.

(24)  Pre-fledged birds may be held in enclosures with a minimum height of 75 cm.

(25)  Pond sizes are per 2 m2 enclosure. The pond may contribute up to 50 % of the minimum enclosure size.

(26)  Measured from snout to vent.

(27)  These conditions apply to holding (i.e. husbandry) tanks but not to those tanks used for natural mating and super-ovulation for reasons of efficiency, as the latter procedures require smaller individual tanks. Space requirements determined for adults in the indicated size categories; juveniles and tadpoles shall either be excluded, or dimensions altered according to the scaling principle.

(28)  Measured from snout to vent.

(29)  Measured from snout to vent.

(30)  One-third land division, two-thirds water division sufficient for animals to submerge.

(31)  Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosures shall be adapted to the interior design.

(32)  Measured from snout to vent.

(33)  Two-thirds land division, one-third water division sufficient for animals to submerge.

(34)  Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosures shall be adapted to the interior design.

(35)  Measured from snout to vent.

(36)  Two-thirds land division, one-third pool division sufficient for animals to submerge.

(37)  Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosures shall be adapted to the interior design.

(38)  Measured in a straight line from the front edge to the back edge of the shell.

(39)  Measured from snout to tail.

(40)  Measured from the surface of the land division up to the inner part of the top of the terrarium; furthermore, the height of the enclosure shall be adapted to the interior design.

---

ANNEX IV

Methods of killing animals

1.   In the process of killing animals, methods listed in the table below shall be used.

Methods other than those listed in the table may be used:

| (a) | on unconscious animals, providing the animal does not regain consciousness before death; |
| --- | --- |

(a)

on unconscious animals, providing the animal does not regain consciousness before death;

| (b) | on animals used in agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept; these animals may be killed in accordance with the requirements laid down in Annex I of Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (1). |
| --- | --- |

(b)

on animals used in agricultural research, when the aim of the project requires that the animals are kept under similar conditions to those under which commercial farm animals are kept; these animals may be killed in accordance with the requirements laid down in Annex I of Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (1).

2.   The killing of animals shall be completed by one of the following methods:

| (a) | confirmation of permanent cessation of the circulation; |
| --- | --- |

(a)

confirmation of permanent cessation of the circulation;

| (b) | destruction of the brain; |
| --- | --- |

(b)

destruction of the brain;

| (c) | dislocation of the neck; |
| --- | --- |

(c)

dislocation of the neck;

| (d) | exsanguination; or |
| --- | --- |

(d)

exsanguination; or

| (e) | confirmation of the onset of rigor mortis. |
| --- | --- |

(e)

confirmation of the onset of rigor mortis.

3.   Table

| Animals-remarks/methods | Fish | Amphibians | Reptiles | Birds | Rodents | Rabbits | Dogs, cats, ferrets and foxes | Large mammals | Non-human primates |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Anaesthetic overdose | (1) | (1) | (1) | (1) | (1) | (1) | (1) | (1) | (1) |
| Captive bolt | | | (2) | | | | | | |
| Carbon dioxide | | | | | (3) | | | | |
| Cervical dislocation | | | | (4) | (5) | (6) | | | |
| Concussion/percussive blow to the head | | | | (7) | (8) | (9) | (10) | | |
| Decapitation | | | | (11) | (12) | | | | |
| Electrical stunning | (13) | (13) | | (13) | | (13) | (13) | (13) | |
| Inert gases (Ar, N2) | | | | | | | | (14) | |
| Shooting with a free bullet with appropriate rifles, guns and ammunition | | | (15) | | | | (16) | (15) | |

Animals-remarks/methods

Fish

Amphibians

Reptiles

Birds

Rodents

Rabbits

Dogs, cats, ferrets and foxes

Large mammals

Non-human primates

Anaesthetic overdose

(1)

(1)

(1)

(1)

(1)

(1)

(1)

(1)

(1)

Captive bolt

(2)

Carbon dioxide

(3)

Cervical dislocation

(4)

(5)

(6)

Concussion/percussive blow to the head

(7)

(8)

(9)

(10)

Decapitation

(11)

(12)

Electrical stunning

(13)

(13)

(13)

(13)

(13)

(13)

Inert gases (Ar, N2)

(14)

Shooting with a free bullet with appropriate rifles, guns and ammunition

(15)

(16)

(15)

Requirements

| (1) | Shall, where appropriate, be used with prior sedation. |
| --- | --- |

(1)

Shall, where appropriate, be used with prior sedation.

| (2) | Only to be used on large reptiles. |
| --- | --- |

(2)

Only to be used on large reptiles.

| (3) | Only to be used in gradual fill. Not to be used for foetal and neonate rodents. |
| --- | --- |

(3)

Only to be used in gradual fill. Not to be used for foetal and neonate rodents.

| (4) | Only to be used for birds under 1 kg. Birds over 250 g shall be sedated. |
| --- | --- |

(4)

Only to be used for birds under 1 kg. Birds over 250 g shall be sedated.

| (5) | Only to be used for rodents under 1 kg. Rodents over 150 g shall be sedated. |
| --- | --- |

(5)

Only to be used for rodents under 1 kg. Rodents over 150 g shall be sedated.

| (6) | Only to be used for rabbits under 1 kg. Rabbits over 150 g shall be sedated. |
| --- | --- |

(6)

Only to be used for rabbits under 1 kg. Rabbits over 150 g shall be sedated.

| (7) | Only to be used for birds under 5 kg. |
| --- | --- |

(7)

Only to be used for birds under 5 kg.

| (8) | Only to be used for rodents under 1 kg. |
| --- | --- |

(8)

Only to be used for rodents under 1 kg.

| (9) | Only to be used for rabbits under 5 kg. |
| --- | --- |

(9)

Only to be used for rabbits under 5 kg.

| (10) | Only to be used on neonates. |
| --- | --- |

(10)

Only to be used on neonates.

| (11) | Only to be used for birds under 250 g. |
| --- | --- |

(11)

Only to be used for birds under 250 g.

| (12) | Only to be used if other methods are not possible. |
| --- | --- |

(12)

Only to be used if other methods are not possible.

| (13) | Specialised equipment required. |
| --- | --- |

(13)

Specialised equipment required.

| (14) | Only to be used on pigs. |
| --- | --- |

(14)

Only to be used on pigs.

| (15) | Only to be used in field conditions by experienced marksmen. |
| --- | --- |

(15)

Only to be used in field conditions by experienced marksmen.

| (16) | Only to be used in field conditions by experienced marksmen when other methods are not possible. |
| --- | --- |

(16)

Only to be used in field conditions by experienced marksmen when other methods are not possible.

---

(1)  OJ L 303, 18.11.2009, p. 1.

---

ANNEX V

List of elements referred to in Article 23(3)

1.   National legislation in force relevant to the acquisition, husbandry, care and use of animals for scientific purposes.

2.   Ethics in relation to human-animal relationship, intrinsic value of life and arguments for and against the use of animals for scientific purposes.

3.   Basic and appropriate species-specific biology in relation to anatomy, physiological features, breeding, genetics and genetic alteration.

4.   Animal behaviour, husbandry and enrichment.

5.   Species-specific methods of handling and procedures, where appropriate.

6.   Animal health management and hygiene.

7.   Recognition of species-specific distress, pain and suffering of most common laboratory species.

8.   Anaesthesia, pain relieving methods and killing.

9.   Use of humane end-points.

10.   Requirement of replacement, reduction and refinement.

11.   Design of procedures and projects, where appropriate.

---

ANNEX VI

List of elements referred to in Article 37 (1)(c)

1.   Relevance and justification of the following:

| (a) | use of animals including their origin, estimated numbers, species and life stages; |
| --- | --- |

(a)

use of animals including their origin, estimated numbers, species and life stages;

| (b) | procedures. |
| --- | --- |

(b)

procedures.

2.   Application of methods to replace, reduce and refine the use of animals in procedures.

3.   The planned use of anaesthesia, analgesia and other pain relieving methods.

4.   Reduction, avoidance and alleviation of any form of animal suffering, from birth to death where appropriate.

5.   Use of humane end-points.

6.   Experimental or observational strategy and statistical design to minimise animal numbers, pain, suffering, distress and environmental impact where appropriate.

7.   Reuse of animals and the accumulative effect thereof on the animals.

8.   The proposed severity classification of procedures.

9.   Avoidance of unjustified duplication of procedures where appropriate.

10.   Housing, husbandry and care conditions for the animals.

11.   Methods of killing.

12.   Competence of persons involved in the project.

---

ANNEX VII

Duties and Tasks of the Union Reference Laboratory

1.   The Union Reference Laboratory referred to in Article 48 is the Commission's Joint Research Centre.

2.   The Union Reference Laboratory shall be responsible, in particular, for:

| (a) | coordinating and promoting the development and use of alternatives to procedures including in the areas of basic and applied research and regulatory testing; |
| --- | --- |

(a)

coordinating and promoting the development and use of alternatives to procedures including in the areas of basic and applied research and regulatory testing;

| (b) | coordinating the validation of alternative approaches at Union level; |
| --- | --- |

(b)

coordinating the validation of alternative approaches at Union level;

| (c) | acting as a focal point for the exchange of information on the development of alternative approaches; |
| --- | --- |

(c)

acting as a focal point for the exchange of information on the development of alternative approaches;

| (d) | setting up, maintaining and managing public databases and information systems on alternative approaches and their state of development; |
| --- | --- |

(d)

setting up, maintaining and managing public databases and information systems on alternative approaches and their state of development;

| (e) | promoting dialogue between legislators, regulators, and all relevant stakeholders, in particular, industry, biomedical scientists, consumer organisations and animal-welfare groups, with a view to the development, validation, regulatory acceptance, international recognition, and application of alternative approaches. |
| --- | --- |

(e)

promoting dialogue between legislators, regulators, and all relevant stakeholders, in particular, industry, biomedical scientists, consumer organisations and animal-welfare groups, with a view to the development, validation, regulatory acceptance, international recognition, and application of alternative approaches.

3.   The Union Reference Laboratory shall participate in the validation of alternative approaches.

---

ANNEX VIII

Severity classification of procedures

The severity of a procedure shall be determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by an individual animal during the course of the procedure.

Section I: Severity categories

Non-recovery:

Procedures which are performed entirely under general anesthesia from which the animal shall not recover consciousness shall be classified as ‘non-recovery’.

Mild:

Procedures on animals as a result of which the animals are likely to experience short-term mild pain, suffering or distress, as well as procedures with no significant impairment of the well-being or general condition of the animals shall be classified as ‘mild’.

Moderate:

Procedures on animals as a result of which the animals are likely to experience short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the well-being or general condition of the animals shall be classified as ‘moderate’.

Severe:

Procedures on animals as a result of which the animals are likely to experience severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that are likely to cause severe impairment of the well-being or general condition of the animals shall be classified as ‘severe’.

Section II: Assignment criteria

The assignment of the severity category shall take into account any intervention or manipulation of an animal within a defined procedure. It shall be based on the most severe effects likely to be experienced by an individual animal after applying all appropriate refinement techniques.

When assigning a procedure to a particular category, the type of procedure and a number of other factors shall be taken into account. All these factors shall be considered on a case-by-case basis.

The factors related to the procedure shall include:

| — | type of manipulation, handling; |
| --- | --- |

—

type of manipulation, handling;

| — | nature of pain, suffering, distress or lasting harm caused by (all elements of) the procedure, and its intensity, the duration, frequency and multiplicity of techniques employed; |
| --- | --- |

—

nature of pain, suffering, distress or lasting harm caused by (all elements of) the procedure, and its intensity, the duration, frequency and multiplicity of techniques employed;

| — | cumulative suffering within a procedure; |
| --- | --- |

—

cumulative suffering within a procedure;

| — | prevention from expressing natural behavior including restrictions on the housing, husbandry and care standards. |
| --- | --- |

—

prevention from expressing natural behavior including restrictions on the housing, husbandry and care standards.

Examples are given in Section III of procedures assigned to each of the severity categories on the basis of factors related to the type of the procedure alone. They shall provide the first indication as to what classification would be the most appropriate for a certain type of procedure.

However, for the purposes of the final severity classification of the procedure, the following additional factors, assessed on a case-by-case basis, shall also be taken into account:

| — | type of species and genotype; |
| --- | --- |

—

type of species and genotype;

| — | maturity, age and gender of the animal; |
| --- | --- |

—

maturity, age and gender of the animal;

| — | training experience of the animal with respect to the procedure; |
| --- | --- |

—

training experience of the animal with respect to the procedure;

| — | if the animal is to be reused, the actual severity of the previous procedures; |
| --- | --- |

—

if the animal is to be reused, the actual severity of the previous procedures;

| — | the methods used to reduce or eliminate pain, suffering and distress, including refinement of housing, husbandry and care conditions; |
| --- | --- |

—

the methods used to reduce or eliminate pain, suffering and distress, including refinement of housing, husbandry and care conditions;

| — | humane end-points. |
| --- | --- |

—

humane end-points.

Section III:

Examples of different types of procedure assigned to each of the severity categories on the basis of factors related to the type of the procedure

1.   Mild:

| (a) | Administration of anesthesia except for the sole purpose of killing; |
| --- | --- |

(a)

Administration of anesthesia except for the sole purpose of killing;

| (b) | Pharmacokinetic study where a single dose is administered and a limited number of blood samples are taken (totaling < 10 % of circulating volume) and the substance is not expected to cause any detectable adverse effect; |
| --- | --- |

(b)

Pharmacokinetic study where a single dose is administered and a limited number of blood samples are taken (totaling < 10 % of circulating volume) and the substance is not expected to cause any detectable adverse effect;

| (c) | Non-invasive imaging of animals (e.g. MRI) with appropriate sedation or anesthesia; |
| --- | --- |

(c)

Non-invasive imaging of animals (e.g. MRI) with appropriate sedation or anesthesia;

| (d) | Superficial procedures, e.g. ear and tail biopsies, non surgical subcutaneous implantation of mini-pumps and transponders; |
| --- | --- |

(d)

Superficial procedures, e.g. ear and tail biopsies, non surgical subcutaneous implantation of mini-pumps and transponders;

| (e) | Application of external telemetry devices that cause only minor impairment to the animals or minor interference with normal activity and behavior; |
| --- | --- |

(e)

Application of external telemetry devices that cause only minor impairment to the animals or minor interference with normal activity and behavior;

| (f) | Administration of substances by subcutaneous, intramuscular, intraperitoneal routes, gavage and intravenously via superficial blood vessels, where the substance has no more than mild impact on the animal, and the volumes are within appropriate limits for the size and species of the animal; |
| --- | --- |

(f)

Administration of substances by subcutaneous, intramuscular, intraperitoneal routes, gavage and intravenously via superficial blood vessels, where the substance has no more than mild impact on the animal, and the volumes are within appropriate limits for the size and species of the animal;

| (g) | Induction of tumors, or spontaneous tumors, that cause no detectable clinical adverse effects (e.g. small, subcutaneous, non-invasive nodules); |
| --- | --- |

(g)

Induction of tumors, or spontaneous tumors, that cause no detectable clinical adverse effects (e.g. small, subcutaneous, non-invasive nodules);

| (h) | Breeding of genetically altered animals, which is expected to result in a phenotype with mild effects; |
| --- | --- |

(h)

Breeding of genetically altered animals, which is expected to result in a phenotype with mild effects;

| (i) | Feeding of modified diets, that do not meet all of the animals' nutritional needs and are expected to cause mild clinical abnormality within the time-scale of the study; |
| --- | --- |

(i)

Feeding of modified diets, that do not meet all of the animals' nutritional needs and are expected to cause mild clinical abnormality within the time-scale of the study;

| (j) | Short-term (<24h) restraint in metabolic cages; |
| --- | --- |

(j)

Short-term (<24h) restraint in metabolic cages;

| (k) | Studies involving short-term deprivation of social partners, short-term solitary caging of adult rats or mice of sociable strains; |
| --- | --- |

(k)

Studies involving short-term deprivation of social partners, short-term solitary caging of adult rats or mice of sociable strains;

| (l) | Models which expose animals to noxious stimuli which are briefly associated with mild pain, suffering or distress, and which the animals can successfully avoid; |
| --- | --- |

(l)

Models which expose animals to noxious stimuli which are briefly associated with mild pain, suffering or distress, and which the animals can successfully avoid;

| (m) | A combination or accumulation of the following examples may result in classification as ‘mild’:






  (i) | assessing body composition by non-invasive measures and with minimal restraint; |
| --- | --- | --- |

(m)

A combination or accumulation of the following examples may result in classification as ‘mild’:

(i)

assessing body composition by non-invasive measures and with minimal restraint;

| (ii) | monitoring ECG with non-invasive techniques with minimal or no restraint of habituated animals; |
| --- | --- |

(ii)

monitoring ECG with non-invasive techniques with minimal or no restraint of habituated animals;

| (iii) | application of external telemetry devices that are expected to cause no impairment to socially adapted animals and do not interfere with normal activity and behaviour; |
| --- | --- |

(iii)

application of external telemetry devices that are expected to cause no impairment to socially adapted animals and do not interfere with normal activity and behaviour;

| (iv) | breeding genetically altered animals which are expected to have no clinically detectable adverse phenotype; |
| --- | --- |

(iv)

breeding genetically altered animals which are expected to have no clinically detectable adverse phenotype;

| (v) | adding inert markers in the diet to follow passage of digesta; |
| --- | --- |

(v)

adding inert markers in the diet to follow passage of digesta;

| (vi) | withdrawal of food for <24h in adult rats; |
| --- | --- |

(vi)

withdrawal of food for <24h in adult rats;

| (vii) | open field testing. |
| --- | --- |

(vii)

open field testing.

2.   Moderate:

| (a) | Frequent application of test substances which produce moderate clinical effects, and withdrawal of blood samples (>10 % of circulating volume) in a conscious animal within a few days without volume replacement; |
| --- | --- |

(a)

Frequent application of test substances which produce moderate clinical effects, and withdrawal of blood samples (>10 % of circulating volume) in a conscious animal within a few days without volume replacement;

| (b) | Acute dose-range finding studies, chronic toxicity/carcinogenicity tests, with non-lethal end-points; |
| --- | --- |

(b)

Acute dose-range finding studies, chronic toxicity/carcinogenicity tests, with non-lethal end-points;

| (c) | Surgery under general anesthesia and appropriate analgesia, associated with post surgical pain, suffering or impairment of general condition. Examples include: thoracotomy, craniotomy, laparotomy, orchidectomy, lymphadenectomy, thyroidectomy, orthopaedic surgery with effective stabilisation and wound management, organ transplantation with effective management of rejection, surgical implantation of catheters, or biomedical devices (e.g. telemetry transmitters, minipumps etc.); |
| --- | --- |

(c)

Surgery under general anesthesia and appropriate analgesia, associated with post surgical pain, suffering or impairment of general condition. Examples include: thoracotomy, craniotomy, laparotomy, orchidectomy, lymphadenectomy, thyroidectomy, orthopaedic surgery with effective stabilisation and wound management, organ transplantation with effective management of rejection, surgical implantation of catheters, or biomedical devices (e.g. telemetry transmitters, minipumps etc.);

| (d) | Models of induction of tumors, or spontaneous tumors, that are expected to cause moderate pain or distress or moderate interference with normal behavior; |
| --- | --- |

(d)

Models of induction of tumors, or spontaneous tumors, that are expected to cause moderate pain or distress or moderate interference with normal behavior;

| (e) | Irradiation or chemotherapy with a sublethal dose, or with an otherwise lethal dose but with reconstitution of the immune system. Adverse effects would be expected to be mild or moderate and would be short-lived (<5 days); |
| --- | --- |

(e)

Irradiation or chemotherapy with a sublethal dose, or with an otherwise lethal dose but with reconstitution of the immune system. Adverse effects would be expected to be mild or moderate and would be short-lived (<5 days);

| (f) | Breeding of genetically altered animals which are expected to result in a phenotype with moderate effects; |
| --- | --- |

(f)

Breeding of genetically altered animals which are expected to result in a phenotype with moderate effects;

| (g) | Creation of genetically altered animals through surgical procedures; |
| --- | --- |

(g)

Creation of genetically altered animals through surgical procedures;

| (h) | Use of metabolic cages involving moderate restriction of movement over a prolonged period (up to 5 days); |
| --- | --- |

(h)

Use of metabolic cages involving moderate restriction of movement over a prolonged period (up to 5 days);

| (i) | Studies with modified diets that do not meet all of the animals' nutritional needs and are expected to cause moderate clinical abnormality within the time-scale of the study; |
| --- | --- |

(i)

Studies with modified diets that do not meet all of the animals' nutritional needs and are expected to cause moderate clinical abnormality within the time-scale of the study;

| (j) | Withdrawal of food for 48 hours in adult rats; |
| --- | --- |

(j)

Withdrawal of food for 48 hours in adult rats;

| (k) | Evoking escape and avoidance reactions where the animal is unable to escape or avoid the stimulus, and are expected to result in moderate distress. |
| --- | --- |

(k)

Evoking escape and avoidance reactions where the animal is unable to escape or avoid the stimulus, and are expected to result in moderate distress.

3.   Severe:

| (a) | Toxicity testing where death is the end-point, or fatalities are to be expected and severe pathophysiological states are induced. For example, single dose acute toxicity testing (see OECD testing guidelines); |
| --- | --- |

(a)

Toxicity testing where death is the end-point, or fatalities are to be expected and severe pathophysiological states are induced. For example, single dose acute toxicity testing (see OECD testing guidelines);

| (b) | Testing of device where failure may cause severe pain, distress or death of the animal (e.g. cardiac assist devices); |
| --- | --- |

(b)

Testing of device where failure may cause severe pain, distress or death of the animal (e.g. cardiac assist devices);

| (c) | Vaccine potency testing characterised by persistent impairment of the animal's condition, progressive disease leading to death, associated with long-lasting moderate pain, distress or suffering; |
| --- | --- |

(c)

Vaccine potency testing characterised by persistent impairment of the animal's condition, progressive disease leading to death, associated with long-lasting moderate pain, distress or suffering;

| (d) | Irradiation or chemotherapy with a lethal dose without reconstitution of the immune system, or reconstitution with production of graft versus host disease; |
| --- | --- |

(d)

Irradiation or chemotherapy with a lethal dose without reconstitution of the immune system, or reconstitution with production of graft versus host disease;

| (e) | Models with induction of tumors, or with spontaneous tumors, that are expected to cause progressive lethal disease associated with long-lasting moderate pain, distress or suffering. For example tumors causing cachexia, invasive bone tumors, tumors resulting in metastatic spread, and tumors that are allowed to ulcerate; |
| --- | --- |

(e)

Models with induction of tumors, or with spontaneous tumors, that are expected to cause progressive lethal disease associated with long-lasting moderate pain, distress or suffering. For example tumors causing cachexia, invasive bone tumors, tumors resulting in metastatic spread, and tumors that are allowed to ulcerate;

| (f) | Surgical and other interventions in animals under general anesthesia which are expected to result in severe or persistent moderate postoperative pain, suffering or distress or severe and persistent impairment of the general condition of the animals. Production of unstable fractures, thoracotomy without adequate analgesia, or trauma to produce multiple organ failure; |
| --- | --- |

(f)

Surgical and other interventions in animals under general anesthesia which are expected to result in severe or persistent moderate postoperative pain, suffering or distress or severe and persistent impairment of the general condition of the animals. Production of unstable fractures, thoracotomy without adequate analgesia, or trauma to produce multiple organ failure;

| (g) | Organ transplantation where organ rejection is likely to lead to severe distress or impairment of the general condition of the animals (e.g. xenotransplantation); |
| --- | --- |

(g)

Organ transplantation where organ rejection is likely to lead to severe distress or impairment of the general condition of the animals (e.g. xenotransplantation);

| (h) | Breeding animals with genetic disorders that are expected to experience severe and persistent impairment of general condition, for example Huntington's disease, Muscular dystrophy, chronic relapsing neuritis models; |
| --- | --- |

(h)

Breeding animals with genetic disorders that are expected to experience severe and persistent impairment of general condition, for example Huntington's disease, Muscular dystrophy, chronic relapsing neuritis models;

| (i) | Use of metabolic cages involving severe restriction of movement over a prolonged period; |
| --- | --- |

(i)

Use of metabolic cages involving severe restriction of movement over a prolonged period;

| (j) | Inescapable electric shock (e.g. to produce learned helplessness); |
| --- | --- |

(j)

Inescapable electric shock (e.g. to produce learned helplessness);

| (k) | Complete isolation for prolonged periods of social species e.g. dogs and non-human primates; |
| --- | --- |

(k)

Complete isolation for prolonged periods of social species e.g. dogs and non-human primates;

| (l) | Immobilisation stress to induce gastric ulcers or cardiac failure in rats; |
| --- | --- |

(l)

Immobilisation stress to induce gastric ulcers or cardiac failure in rats;

| (m) | Forced swim or exercise tests with exhaustion as the end-point. |
| --- | --- |

(m)

Forced swim or exercise tests with exhaustion as the end-point.

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STATEMENT OF THE COUNCIL'S REASONS

I.   INTRODUCTION

On 5 November 2008, the Commission submitted to the Council the above proposal which is based on Article 95 TEC (Article 114 TFEU). Its objective is to ensure a level playing field throughout the EU for industry and the research community and to strengthen the protection of animals still used in scientific procedures.

The European Parliament adopted its first-reading opinion on 5 May 2009 (1).

The Economic and Social Committee adopted its opinion on 13 May 2009 (2).

The Council adopted its position at first reading in accordance with Article 294 of the TFEU on 3 June 2010.

II.   OBJECTIVES

The main objectives of the proposed Directive is to ensure a level playing field throughout the EU for industry and the research community and to strengthen the protection of animals still used in scientific procedures. It aims at re-establishing the objectives of the internal market by rectifying a variety of weaknesses in the current Directive which have lead into considerable differences in its national implementation by the Member States. While recognising that the use of animals in scientific procedures today still remains essential for an unforeseeable future for ensuring a level of safety for human beings, animals and the environment, the proposal introduces a number of measures to promote alternative approaches, including their development, validation, acceptance and implementation, also at international level. Generally the proposal requires that the commonly accepted principles of the ‘Three Rs’ — Replacement, Reduction and Refinement of animals in experiments — are fully taken into account when developing Community measures in this domain.

III.   ANALYSIS OF THE COUNCIL'S POSITION

A.   General observations

The Council's position confirms the objectives proposed by the Commission and incorporates the majority of the European Parliament's first-reading amendments, either verbatim, in part or in spirit.

The Council's position also includes a number of changes other than those envisaged in the European Parliament's first-reading opinion. These changes have been thoroughly negotiated with the European Parliament, which has confirmed its provisional agreement on the full text by a letter.

B.   Specific comments

1.   Main amendments to the Commission proposal

(a)   Authorisation of persons

With the aim to reduce administrative burden and to better cater for different types of operators, the Council removed the proposed mandatory authorisation of persons carrying out or supervising procedures, putting the emphasis on the requirements on competence of staff. These requirements include the obligation to specify in the authorisation of each breeder, supplier and user a person responsible for ensuring the adequate education, competence and continuous training of the staff.

(b)   Union Reference Laboratory

In line with an amendment of the Parliament, the Council strengthened the promotion of alternative methods at Union level by the introduction of a centralised Union Reference Laboratory, assigning it a set of responsibilities, including coordination and validation of alternative approaches and acting as a focal point for the exchange of information on their development.

(c)   Safeguard clauses

The Council introduced two additional safeguard clauses to take into account possible future situations where, for scientifically justifiable grounds, Member States deem it is necessary to authorise the use of non-human primates in areas not linked with debilitating and life-threatening conditions in humans or to surpass the upper limit for severity of procedures. This authorisation could only be provisional and would be subject to a Union control procedure.

(d)   Classification of the severity of procedures

Sharing the approach of the Parliament, the Council introduced in the Directive a system for a uniform classification of severity of procedures.

2.   Council's position on the European Parliament's amendments

With the view to reaching an early agreement, the Council examined every amendment of the European Parliament. Whenever possible, amendments were accepted, either in full or partially; sometimes the spirit of an amendment was addressed in another Article or Recital.

Thus, in its position, the Council has

| — | Accepted fully (sometimes with redrafting), partly or in spirit the following amendments: 28, 30, 31, 33, 35, 37, 43, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 59, 60, 61, 64, 65, 66, 67, 68, 69, 70 + 175, 71 + 185, 72, 73, 74, 75, 76, 77, 78, 79, 81, 82, 83, 84, 85, 87, 89, 91, 92, 97, 98, 99, 100, 101, 102, 103, 105, 108, 109, 110, 112, 114, 115, 116, 117, 119, 121, 123, 124, 125, 126, 127, 129, 135, 136, 139, 140, 141, 142, 145, 150, 151, 152, 160, 161, 168, 169, 170, 193 and 194; |
| --- | --- |

—

Accepted fully (sometimes with redrafting), partly or in spirit the following amendments: 28, 30, 31, 33, 35, 37, 43, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 59, 60, 61, 64, 65, 66, 67, 68, 69, 70 + 175, 71 + 185, 72, 73, 74, 75, 76, 77, 78, 79, 81, 82, 83, 84, 85, 87, 89, 91, 92, 97, 98, 99, 100, 101, 102, 103, 105, 108, 109, 110, 112, 114, 115, 116, 117, 119, 121, 123, 124, 125, 126, 127, 129, 135, 136, 139, 140, 141, 142, 145, 150, 151, 152, 160, 161, 168, 169, 170, 193 and 194;

| — | Not been able to accept the following amendments: 29, 32, 34, 36, 38, 39, 40, 41, 42, 44, 46, 57, 58, 62, 63, 80, 86, 88, 90, 93, 94, 95, 96, 104, 111, 113, 118, 120, 122, 128, 131+187, 132, 134, 137, 138, 143, 144, 147, 148, 153, 154, 155, 156, 157, 158, 159, 167, 176 + 186, 178, and 180. |
| --- | --- |

—

Not been able to accept the following amendments: 29, 32, 34, 36, 38, 39, 40, 41, 42, 44, 46, 57, 58, 62, 63, 80, 86, 88, 90, 93, 94, 95, 96, 104, 111, 113, 118, 120, 122, 128, 131+187, 132, 134, 137, 138, 143, 144, 147, 148, 153, 154, 155, 156, 157, 158, 159, 167, 176 + 186, 178, and 180.

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(1)  Doc. 9312/09.

(2)  NAT/422 — CESE 874/2009.

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