1.   The GMES programme shall build on the research activities carried out under Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (14) and the GMES Space Component Programme of ESA.

2.   The GMES programme shall comprise the following:

1.   GMES initial operations shall cover the period 2011–2013 and may comprise operational actions in the following fields:

2.   The objectives of the operational actions referred to in paragraph 1 are defined in the Annex.

1.   The Commission shall ensure the coordination of the GMES programme with activities at national, Union and international levels, notably GEOSS. The implementation and operation of GMES shall be based on partnerships between the Union and the Member States, in compliance with their respective rules and procedures. The voluntary contributions of Member States, and the potential synergies with relevant national, Union and international initiatives, shall be coordinated in accordance with the advisory procedure referred to in Article 16(5).

2.   The Commission shall manage the funds allocated to the activities under this Regulation in accordance with the Financial Regulation and with the management procedure referred to in Article 16(4). It shall ensure the complementarity and consistency of the GMES programme with other relevant Union policies, instruments and actions, relating in particular to the environment, security, competitiveness and innovation, cohesion, research (in particular the activities of the Seventh Framework Programme linked to GMES, without prejudice to Decision No 1982/2006/EC), transport and competition, international cooperation, the European Global Navigation Satellite Systems (GNSS) programmes, the protection of personal data and existing intellectual property rights, Directive 2007/2/EC, the Shared Environmental Information System (SEIS) and Union activities in the field of emergency response.

3.   Since GMES is a user-driven programme, the Commission shall ensure that service specifications match user needs. To that end, it shall establish a transparent mechanism for regular user involvement and consultation, enabling identification of user requirements at Union and national level. The Commission shall ensure coordination with relevant public sector users in Member States, third countries and international organisations. Service data requirements shall be established independently by the Commission after consultation of the User Forum.

4.   Technical coordination and implementation of the GMES space component shall be delegated to ESA, relying on the European Organisation for the Exploitation of Meteorological Satellites (EUMETSAT) where necessary.

5.   The Commission shall entrust the coordination of the technical implementation of the GMES services, where appropriate, to competent Union bodies or intergovernmental organisations.

1.   The Commission shall take adequate measures to ensure effective competition in the provision of GMES services and to promote the participation of SMEs. The Commission shall facilitate the use of the GMES services output to develop the downstream sector.

2.   The provision of GMES services shall be decentralised, where appropriate, to integrate at European level existing space, in-situ and reference data inventories and capacities in Member States, thus avoiding duplication. Procurement of new data that duplicate existing sources shall be avoided unless the use of existing or upgradable data sets is not technically feasible or cost-effective.

3.   The Commission, taking into account the opinion of the User Forum, may define or validate appropriate procedures for the certification of the production of data within the framework of the GMES programme. Those procedures shall be transparent, verifiable and auditable to ensure authenticity, traceability and data integrity for the user. In its contractual arrangements with GMES service operators, the Commission shall ensure that those procedures are implemented.

4.   The Commission shall report annually on the results achieved in the implementation of this Article.

1.   Union funding may take the following legal forms:

2.   Genuine competition, transparency and equal treatment shall be ensured in the provision of funding by the Union. Where justified, Union grants may be provided in specific forms, including framework partnership agreements, or co-funding of operating or action grants. Operating grants to bodies pursuing objectives of general European interest shall not be subject to the degressivity provisions of the Financial Regulation. For grants, the maximum rate of co-financing shall be set in accordance with the management procedure referred to in Article 16(4).

3.   The Commission shall report on the allocation of Union funds to each of the activities specified in Article 3(1) and on the evaluation process and results of the procurement tenders and of the contracts concluded on the basis of this Article, after the award of the contracts.

1.   The financial envelope allocated to the operational actions referred to in Article 3(1) shall be EUR 107 million.

2.   Appropriations shall be authorised annually by the budgetary authority within the limits laid down in the MFF.

3.   Third countries or international organisations may also provide additional funding for the GMES programme.

The additional funding referred to in the first subparagraph shall be treated as assigned revenue, in accordance with Article 18 of the Financial Regulation.

1.   The data and information policy for actions financed under the GMES programme shall have the following objectives:

2.   For the purpose of providing for a framework to ensure the attainment of the GMES information and data policy objective referred to in point (b) of paragraph 1 while providing for the necessary protection of the information produced by the GMES services and of data collected through the GMES dedicated infrastructure, the Commission may adopt, by means of delegated acts in accordance with Article 10 and subject to the conditions specified in Articles 11 and 12, the following measures, taking into account the data and information policies of providers of data needed for GMES, and without prejudice to national rules and procedures applicable to space and in-situ infrastructures under national control:

1.   The powers to adopt the delegated acts referred to in Article 9(2) shall be conferred on the Commission until 31 December 2013.

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 powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 11 and 12.

1.   The delegation of powers referred to in Article 9(2) 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 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.

1.   The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.

At the initiative of the European Parliament or the Council, that period shall be extended by 2 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.

1.   On the basis of the criteria referred to in point (b) of Article 9(2), the Commission shall adopt specific measures in accordance with the regulatory procedure referred to in Article 16(3), for restricting access to the information produced by GMES services and data collected through the GMES dedicated infrastructure.

2.   The Commission shall ensure overall coordination with regard to the security of the GMES components and services, taking into account the need for oversight and integration of the security requirements of all its elements, without prejudice to national rules and procedures applicable to space and in-situ infrastructures under national control. In particular, the Commission shall adopt measures, in accordance with the regulatory procedure referred to in Article 16(3), laying down technical requirements in order to ensure the control and integrity of the system within the GMES space component dedicated programme, and to control the access to, and handling of, technologies that provide security to the GMES space component dedicated programme.

1.   The Commission shall monitor and evaluate the implementation of the operational actions referred to in Article 3(1).

2.   The Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions an interim evaluation report by 31 December 2012 and an ex-post evaluation report by 31 December 2015.

1.   The Commission shall adopt the annual work programme pursuant to Article 110 of the Financial Regulation and Articles 90 and 166 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (15) in accordance with the management procedure referred to in Article 16(4) of this Regulation.

2.   The financial allocation for the GMES programme may also cover expenses relating to preparatory, monitoring, control, audit and evaluation activities which are required directly for the management of the GMES programme and the achievement of its objectives, and in particular studies, meetings, information and publication actions, together with all other technical and administrative assistance expenses that the Commission may incur for the management of the GMES programme.

1.   The Commission shall be assisted by a committee (the ‘GMES Committee’).

2.   The GMES Committee may meet in specific configurations to deal with concrete issues, notably those relating to security (the ‘Security Board’).

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 2 months.

4.   Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at 2 months.

5.   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.

1.   The User Forum is hereby set up as a dedicated body. It shall advise the Commission with regard to the definition and validation of user requirements, and to the coordination of the GMES programme with its public sector users.

2.   The User Forum shall be chaired by the Commission. It shall consist of GMES public sector users appointed by the Member States.

3.   The Secretariat of the User Forum shall be provided by the Commission.

4.   The User Forum shall adopt its rules of procedure.

5.   The GMES Committee shall be kept fully informed of the advice of the User Forum for the implementation of the GMES programme.

1.   The Commission shall ensure that, when actions financed under this Regulation are implemented, the financial interests of the Union are protected by the application of preventive measures against fraud, corruption and any other illegal activities, by means of effective checks and by the recovery of amounts unduly paid and, if irregularities are detected, by effective, proportional and dissuasive penalties, in accordance with Regulation (EC, Euratom) No 2988/95, Regulation (Euratom, EC) No 2185/96 and Regulation (EC) No 1073/1999.

2.   For the Union actions financed under this Regulation, the notion of irregularity referred to in Article 1(2) of Regulation (EC, Euratom) No 2988/95 shall mean any infringement of a provision of Union law or any breach of a contractual obligation resulting from an act or omission by an economic operator which has, or would have, the effect of prejudicing the general budget of the European Union by an unjustified item of expenditure.

3.   Agreements resulting from this Regulation, including agreements concluded with participating third countries and international organisations, shall provide for supervision and financial control by the Commission, or any representative authorised by it, and audits by the Court of Auditors, if necessary on-the-spot audits.

1.   The Agency shall be a body of the Union. It shall have legal personality.

2.   In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their law. It may, in particular, acquire or dispose of movable and immovable property and be a party to legal proceedings.

3.   The Agency may decide to establish local offices in Member States subject to their consent, or in third countries participating in the work of the Agency in accordance with Article 23.

4.   Subject to Article 11(9), the Agency shall be represented by its Executive Director.

1.   An Administrative Board is hereby set up to carry out the tasks listed in Article 6.

2.   The Administrative Board shall be composed of one representative appointed by each Member State, five representatives appointed by the Commission and a non-voting representative appointed by the European Parliament. The duration of the term of office of the Administrative Board members shall be 5 years. The term of office may be renewed for a maximum of 5 years. A representative of the HR and a representative of the ESA shall be invited to attend the Administrative Board’s meetings as observers.

3.   Where appropriate, the participation of representatives of third countries and the conditions thereof shall be established in the arrangements referred to in Article 23.

4.   The Administrative Board shall elect a Chairperson and a Deputy Chairperson from among its members. The Deputy Chairperson shall automatically take the place of the Chairperson where the Chairperson is prevented from attending to his duties. The term of office of the Chairperson and of the Deputy Chairperson shall be 2,5 years, renewable once, and shall expire when they cease to be members of the Administrative Board.

5.   The meetings of the Administrative Board shall be convened by its Chairperson.

The Executive Director shall normally take part in the deliberations, unless the Chairperson decides otherwise.

The Administrative Board shall hold an ordinary meeting twice a year. In addition, it shall meet on the initiative of its Chairperson or at the request of at least a third of its members.

The Administrative Board may invite any person whose opinion may be of interest to attend its meetings as an observer. The members of the Administrative Board may, subject to the provisions of its rules of procedure, be assisted by advisers or experts.

The secretariat of the Administrative Board shall be provided by the Agency.

6.   Unless otherwise provided in this Regulation, the Administrative Board shall take its decisions by a two-thirds majority of its members.

7.   Each representative of the Member States and of the Commission shall have one vote. Decisions based on Article 6(b) and (e) shall not be adopted without a favourable vote of the representatives of the Commission. The Executive Director shall not vote.

The rules of procedure of the Administrative Board shall establish more detailed voting arrangements, in particular the conditions for a member to act on behalf of another member.

1.   The Agency shall be managed by its Executive Director, who shall carry out his duties under the supervision of the Administrative Board.

2.   The Executive Director shall be appointed by the Administrative Board on the grounds of merit and documented administrative and managerial skills, as well as relevant competence and experience, from a list of at least three candidates proposed by the Commission, after an open competition, following publication in the Official Journal of the European Union and elsewhere of a call for expressions of interest. The Administrative Board shall take its decision to appoint the Executive Director by a three-quarters majority of its members.

The Administrative Board shall have the power to dismiss the Executive Director and shall adopt its decision to that effect by a three-quarters majority of its members.

The term of office of the Executive Director shall be 5 years. This term of office may be renewed once for a further 5-year period.

3.   The European Parliament or the Council may call upon the Executive Director to submit a report on the performance of his tasks, and to make a statement before those institutions.

1.   In accordance with Article 13(4) of Regulation (EC) No 683/2008, whenever the security of the Union or of the Member States may be affected by the operation of the systems, the procedures set out in Joint Action 2004/552/CFSP shall apply.

2.   The security accreditation decisions taken pursuant to Chapter III, as well as the residual risks identified, shall be communicated by the Commission to the Council for information.

1.   A Security Accreditation Board for European GNSS systems (hereinafter the ‘Security Accreditation Board’) shall be established within the Agency. In relation to the European GNSS systems, the Security Accreditation Board shall have the tasks of the security accreditation authority, as referred to in the relevant security rules applicable to the Council and the Commission.

2.   The Security Accreditation Board shall perform the tasks entrusted to the Agency with regard to security accreditation under Article 16(a)(i) of Regulation (EC) No 683/2008 and take ‘security accreditation decisions’ as provided for in the present Article, in particular on the approval of the security accreditation strategy and of satellite launches, the authorisation to operate the systems in their different configurations and for the various services, the authorisation to operate the ground stations and in particular the sensor stations located in third countries, as well as the authorisation to manufacture receivers containing PRS technology and their components.

3.   The security accreditation of the systems by the Security Accreditation Board shall consist of the establishment of compliance of the systems with the security requirements referred to in Article 13 of Regulation (EC) No 683/2008 and in accordance with the relevant security rules and regulations applicable to the Council and the Commission.

4.   On the basis of the risk reports referred to in paragraph 11, the Security Accreditation Board shall inform the Commission of its risk assessment and provide advice to the Commission on residual risk treatment options for a given security accreditation decision.

5.   The Commission shall keep the Security Accreditation Board continuously informed of the impact of any envisaged decisions of the Security Accreditation Board on the proper conduct of the programmes and of the implementation of residual risk treatment plans. The Security Accreditation Board shall take note of any such opinion of the Commission.

6.   The decisions of the Security Accreditation Board shall be addressed to the Commission.

7.   The Security Accreditation Board shall be composed of one representative per Member State, one representative from the Commission and one from the HR. A representative of ESA shall be invited to attend the meetings of the Security Accreditation Board as an observer.

8.   The Security Accreditation Board shall establish its rules of procedure and shall appoint its Chairperson.

9.   The Chairperson of the Security Accreditation Board shall be responsible for representing the Agency insofar as the Executive Director, according to Article 8, is not responsible.

10.   The Security Accreditation Board shall have access to all the human and material resources required to provide appropriate administrative support functions and to enable it, together with the bodies referred to in paragraph 11, to perform its tasks independently, in particular when handling files, initiating and monitoring the implementation of security procedures and performing system security audits, preparing decisions and organising its meetings.

11.   The Security Accreditation Board shall set up special subordinate bodies, acting on its instructions, to deal with specific issues. In particular, while ensuring necessary continuity of work, it shall set up:

12.   If consensus according to the general principles referred to in Article 10 of this Regulation cannot be reached, the Security Accreditation Board shall take decisions on the basis of majority voting, as provided for in Article 16 of the Treaty on European Union and without prejudice to Article 9 of this Regulation. The representative of the Commission and the representative of the HR shall not vote. The Chairperson of the Security Accreditation Board shall sign, on behalf of the Security Accreditation Board, the decisions adopted by the Security Accreditation Board.

13.   The Commission shall keep the European Parliament and the Council informed, without undue delay, about the impact of the adoption of the security accreditation decisions on the proper conduct of the programmes. If the Commission considers that a decision taken by the Security Accreditation Board may have a significant effect on the proper conduct of the programmes, for example in terms of costs and schedule, it shall immediately inform the European Parliament and the Council.

14.   Taking into account the views of the European Parliament and of the Council, which should be expressed within 1 month, the Commission may adopt any adequate measures in accordance with Regulation (EC) No 683/2008.

15.   The Administrative Board shall be regularly kept informed of the evolution of the work of the Security Accreditation Board.

16.   The timetable for the work of the Security Accreditation Board shall respect the GNSS work programme of the Commission.

1.   Without prejudice to other resources and dues yet to be defined, revenue of the Agency shall include a Union subsidy entered in the general budget of the European Union in order to ensure a balance between revenue and expenditure.

2.   The expenditure of the Agency shall cover staff, administrative and infrastructure expenditure, operating costs and expenditure associated with the functioning of the Security Accreditation Board, including the bodies referred to in Article 11(11), and the contracts and agreements concluded by the Agency in order to accomplish the tasks entrusted to it.

3.   The Executive Director shall draw up a draft statement of estimates of the revenue and expenditure of the Agency for the following year and shall forward it to the Administrative Board, together with a draft establishment plan.

4.   Revenue and expenditure shall be in balance.

5.   Each year the Administrative Board, on the basis of the draft statement of revenue and expenditure, shall produce a statement of estimates of revenue and expenditure for the Agency for the following financial year.

6.   This statement of estimates, which shall include a draft establishment plan together with the provisional work programme, shall, by 31 March, be forwarded by the Administrative Board to the Commission and to the third countries with which the Union has concluded agreements in accordance with Article 23.

7.   The statement of estimates shall be forwarded by the Commission to the European Parliament and to the Council (hereinafter the ‘budgetary authority’) together with the draft general budget of the European Union.

8.   On the basis of the statement of estimates, the Commission shall enter in the draft general budget of the European Union the estimates it deems necessary for the establishment plan and the amount of the subsidy to be charged to the general budget, which it shall place before the budgetary authority in accordance with Article 314 of the Treaty on the Functioning of the European Union.

9.   The budgetary authority shall authorise the appropriations for the subsidy to the Agency and shall adopt the establishment plan for the Agency.

10.   The budget shall be adopted by the Administrative Board. It shall become final following definitive adoption of the general budget of the European Union. Where appropriate, it shall be adjusted accordingly.

11.   The Administrative Board shall, as soon as possible, notify the budgetary authority of its intention to implement any project which will have significant financial implications for the funding of the budget, in particular any projects relating to property such as the rental or purchase of buildings. It shall inform the Commission thereof.

12.   Where a branch of the budgetary authority has notified its intention to deliver an opinion, it shall forward its opinion to the Administrative Board within a period of 6 weeks from the date of notification of the project.

1.   The Executive Director shall implement the budget of the Agency.

2.   By 1 March following each financial year, the accounting officer of the Agency shall communicate the provisional accounts to the Commission’s accounting officer, together with a report on the budgetary and financial management for that financial year. The Commission’s accounting officer shall consolidate the provisional accounts of the institutions and decentralised bodies in accordance with Article 128 of Regulation (EC, Euratom) No 1605/2002.

3.   By 31 March following each financial year, the Commission’s accounting officer shall forward the provisional accounts of the Agency to the Court of Auditors, together with a report on the budgetary and financial management for that financial year. The report shall also be forwarded to the European Parliament and the Council.

4.   On receipt of the Court of Auditors’ observations on the provisional accounts of the Agency, under Article 129 of Regulation (EC, Euratom) No 1605/2002, the Executive Director shall draw up the final accounts of the Agency under his own responsibility and submit them to the Administrative Board for an opinion.

5.   The Administrative Board shall deliver an opinion on the final accounts of the Agency.

6.   The Executive Director shall, by 1 July following each financial year, forward the final accounts to the European Parliament, the Council, the Commission and the Court of Auditors, together with the Administrative Board’s opinion.

7.   The final accounts shall be published.

8.   The Executive Director shall send the Court of Auditors a reply to its observations by 30 September. He shall also send this reply to the Administrative Board.

9.   The Executive Director shall submit to the European Parliament, at the latter’s request, all information necessary for the smooth application of the discharge procedure for the financial year in question, as laid down in Article 146(3) of Regulation (EC, Euratom) No 1605/2002.

10.   The European Parliament, on a recommendation from the Council acting on a qualified majority, shall, before 30 April of the year N + 2, grant discharge to the Executive Director in respect of the implementation of the budget for year N.

1.   In order to combat fraud, corruption and other unlawful activities, the provisions of Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations conducted by the European Anti-Fraud Office (OLAF) (9) shall apply without restriction.

2.   The Agency shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council of the European Union and the Commission of the European Communities concerning internal investigations by the European Anti Fraud Office (OLAF) (10) and shall issue, without delay, appropriate provisions applicable to all staff of the Agency.

3.   The decisions concerning funding, and the implementing agreements and instruments resulting there from, shall explicitly stipulate that the Court of Auditors and OLAF may, if necessary, carry out on-the-spot checks on the recipients of funding of the Agency and the agents responsible for allocating it.

1.   The Staff Regulations of Officials of the European Union, the Conditions of employment of other servants of the European Union and the rules adopted jointly by the institutions of the European Union for the purposes of the application of those Staff Regulations and Conditions of employment shall apply to the staff of the Agency. The Administrative Board, in agreement with the Commission, shall adopt the necessary detailed rules of application.

2.   Without prejudice to Article 8, the powers conferred on the appointing authority by the Staff Regulations and the Conditions of employment of other servants shall be exercised by the Agency with respect to its own staff.

3.   The staff of the Agency shall consist of servants recruited by the Agency as necessary to perform its tasks, but may also include officials with the appropriate clearance who have been assigned or seconded by the Commission or the Member States on a temporary basis.

4.   The provisions laid down in paragraphs 1 and 3 shall also apply to the staff of the GSMC.

1.   The contractual liability of the Agency shall be governed by the law applicable to the contract in question. The Court of Justice shall have jurisdiction to give judgement pursuant to any arbitration clause contained in a contract concluded by the Agency.

2.   In the event of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its departments or by its servants in the performance of their duties.

3.   The Court of Justice shall have jurisdiction in any dispute relating to compensation for damage referred to in paragraph 2.

4.   The personal liability of its servants towards the Agency shall be governed by the provisions laid down in the Staff Regulations or Conditions of employment applicable to them.

1.   The provisions laid down in Regulation No 1 of 15 April 1958 determining the languages to be used in the European Economic Community (11) shall apply to the Agency.

2.   The translation services required for the functioning of the Agency shall be provided by the Translation Centre for the bodies of the European Union.

1.   Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (12) shall apply to documents held by the Agency.

2.   The Administrative Board shall adopt arrangements for implementing Regulation (EC) No 1049/2001 within 6 months from the entry into force of this Regulation.

3.   Decisions taken by the Agency in pursuance of Article 8 of Regulation (EC) No 1049/2001 may be the subject of a complaint to the Ombudsman or an action before the Court of Justice of the European Union, under Articles 228 and 263 of the Treaty on the Functioning of the European Union respectively.

4.   When processing data relating to individuals, the Agency shall be subject to the provisions of Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (13).

1.   The Agency shall be open to the participation of third countries that have entered into agreements with the European Union to this effect.

2.   Under the relevant provisions of these agreements, arrangements shall be developed specifying, in particular, the nature, extent and manner in which these countries will participate in the work of the Agency, including provisions relating to participation in the initiatives undertaken by the Agency, financial contributions and staff.

1.   This Regulation lays down rules for the establishment and organisation of international rail corridors for competitive rail freight with a view to the development of a European rail network for competitive freight. It sets out rules for the selection, organisation, management and the indicative investment planning of freight corridors.

2.   This Regulation shall apply to the management and use of railway infrastructure included in freight corridors.

1.   For the purposes of this Regulation, the definitions laid down in Article 2 of Directive 2001/14/EC shall apply.

2.   In addition to the definitions referred to in paragraph 1:

1.   Each Member State with a rail border with another Member State shall participate in the establishment of at least one freight corridor, unless this obligation has already been met under Article 3.

2.   Notwithstanding paragraph 1, Member States shall, upon request from a Member State, participate in the establishment of the freight corridor as referred to in that paragraph or the prolongation of an existing corridor, in order to allow a neighbouring Member State to fulfil its obligation under that paragraph.

3.   Without prejudice to the obligations of Member States under Article 7 of Directive 91/440/EEC, where a Member State considers, after having provided a socio-economic analysis, that the establishment of a freight corridor would not be in the interest of the applicants likely to use the freight corridor or would not bring significant socio-economic benefits or would cause a disproportionate burden, the Member State concerned shall not be obliged to participate as referred to in paragraphs 1 and 2 of this Article, subject to a decision of the Commission acting in accordance with the advisory procedure referred to in Article 21(2).

4.   A Member State shall not be obliged to participate as referred to in paragraphs 1 and 2 if it has a rail network which has a track gauge which is different from that of the main rail network within the Union.

5.   The establishment of a freight corridor shall be proposed by the Member States concerned. For this purpose they shall send jointly to the Commission a letter of intent including a proposal drawn up after consultation of the infrastructure managers and applicants concerned, taking into account the criteria set out in Article 4.

In order to meet the obligation under paragraphs 1 and 2, the Member States concerned shall send jointly to the Commission a letter of intent by 10 November 2012.

6.   The Commission shall examine the proposals for the establishment of a freight corridor as referred to in paragraph 5 and, in accordance with the regulatory procedure referred to in Article 21(3), adopt a decision on the compliance of such a proposal with this Article at the latest 9 months after submission of the proposal.

7.   The Member States concerned shall establish the freight corridor at the latest two years after the decision of the Commission referred to in paragraph 6.

1.   The freight corridors referred to in Article 5 may be modified on the basis of a joint proposal by the Member States concerned to the Commission after consulting the infrastructure managers and applicants concerned.

2.   The Commission shall, in accordance with the regulatory procedure referred to in Article 21(3), adopt a decision on the proposal taking into account the criteria set out in Article 4.

1.   For each freight corridor, Member States concerned shall establish an executive board responsible for defining the general objectives of the freight corridor, supervising and taking the measures as expressly provided for in paragraph 7 of this Article, and in Articles 9 and 11, Article 14(1) and Article 22. The executive board shall be composed of representatives of the authorities of the Member States concerned.

2.   For each freight corridor, the infrastructure managers concerned and, where relevant, the allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC, shall establish a management board responsible for taking the measures as expressly provided for in paragraphs 5, 7, 8 and 9 of this Article, and in Articles 9 to 12, Article 13(1), Article 14(2), (6) and (9), Article 16(1), Article 17(1) and Articles 18 and 19 of this Regulation. The management board shall be composed of the representatives of the infrastructure managers.

3.   The Member States and infrastructure managers concerned by a freight corridor shall cooperate within the boards referred to in paragraphs 1 and 2 to ensure the development of the freight corridor in accordance with its implementation plan.

4.   The executive board shall take its decisions on the basis of mutual consent of the representatives of the authorities of the Member States concerned.

5.   The management board shall take its decisions, including decisions regarding its legal status, the establishment of its organisational structure, resources and staffing, on the basis of mutual consent of the infrastructure managers concerned. The management board may be an independent legal entity. It may take the form of a European economic interest grouping within the meaning of Council Regulation (EEC) No 2137/85 of 25 July 1985 on the European Economic Interest Grouping (EEIG) (8).

6.   The responsibilities of the executive and management boards shall be without prejudice to the independence of infrastructure managers as provided for in Article 4(2) of Directive 91/440/EEC.

7.   The management board shall set up an advisory group made up of managers and owners of the terminals of the freight corridor including, where necessary, sea and inland waterway ports. This advisory group may issue an opinion on any proposal by the management board which has direct consequences for investment and the management of terminals. It may also issue own-initiative opinions. The management board shall take any of these opinions into account. In the event of disagreement between the management board and the advisory group, the latter may refer the matter to the executive board. The executive board shall act as an intermediary and provide its opinion in due time. The final decision however shall be taken by the management board.

8.   The management board shall set up a further advisory group made up of railway undertakings interested in the use of the freight corridor. This advisory group may issue an opinion on any proposal by the management board which has consequences for these undertakings. It may also issue own-initiative opinions. The management board shall take any of these opinions into account.

9.   The management board shall coordinate in accordance with national and European deployment plans the use of interoperable IT applications or alternative solutions that may become available in the future to handle requests for international train paths and the operation of international traffic on the freight corridor.

1.   The management board shall draw up an implementation plan at the latest 6 months before making the freight corridor operational and shall submit it for approval to the executive board. This plan shall include:

2.   The management board shall periodically review the implementation plan taking into account progress made in its implementation, the rail freight market on the freight corridor and performance measured in accordance with the objectives referred to in point (c) of paragraph 1.

3.   The management board shall carry out and periodically update a transport market study relating to the observed and expected changes in the traffic on the freight corridor, as a consequence of its being established, covering the different types of traffic, both regarding the transport of freight and the transport of passengers. This study shall also review, where necessary, the socio-economic costs and benefits stemming from the establishment of the freight corridor.

4.   The implementation plan shall take into account the development of terminals to meet the needs of rail freight running on the freight corridor, in particular by acting as intermodal nodes along the freight corridors.

5.   The management board shall, as appropriate, take measures to cooperate with regional and/or local administrations in respect of the implementation plan.

1.   The management board shall draw up and periodically review an investment plan, which includes details of indicative medium and long-term investment for infrastructure in the freight corridor, and shall submit it for approval to the executive board. This plan shall include:

2.   The application of this Regulation shall be without prejudice to the competence of the Member States regarding planning of and funding for rail infrastructure.

1.   The management board for a freight corridor shall designate or set up a joint body for applicants to request and to receive answers, in a single place and in a single operation, regarding infrastructure capacity for freight trains crossing at least one border along the freight corridor (hereinafter referred to as a ‘one-stop shop’).

2.   The one-stop shop shall, as a coordination tool, also provide basic information concerning the allocation of the infrastructure capacity, including the information referred in Article 18. It shall display infrastructure capacity available at the time of request and its characteristics in accordance with pre-defined parameters, such as speed, length, loading gauge or axle load authorised for trains running on the freight corridor.

3.   The one-stop shop shall take a decision with regard to applications for pre-arranged train paths specified in Article 14(3) and for the reserve capacity specified in Article 14(5). It shall allocate the capacity in line with rules regarding capacity allocation as set out in Directive 2001/14/EC. It shall inform the competent infrastructure managers of these applications and the decision taken without delay.

4.   For any request of infrastructure capacity which cannot be met pursuant to paragraph 3, the one-stop shop shall forward the application for infrastructure capacity without any delay to the competent infrastructure managers and, where relevant, the allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC, who shall take a decision on that application in accordance with Article 13 and Chapter III of that Directive and communicate this decision to the one-stop shop for further processing.

5.   The activities of the one-stop shop shall be carried out in a transparent and non-discriminatory manner. To this end a register shall be kept which shall be made freely available to all interested parties. It shall contain the dates of the requests, names of the applicants, details of documentation supplied and of incidents which have occurred. These activities shall be subject to the control of the regulatory bodies in accordance with Article 20.

1.   The executive board shall define the framework for the allocation of the infrastructure capacity on the freight corridor in accordance with Article 14(1) of Directive 2001/14/EC.

2.   The management board shall evaluate the need for capacity to be allocated to freight trains running on the freight corridor taking into account the transport market study referred to in Article 9(3) of this Regulation, the requests for infrastructure capacity relating to the past and present working timetables and the framework agreements.

3.   On the basis of the evaluation specified in paragraph 2 of this Article, infrastructure managers of the freight corridor shall jointly define and organise international pre-arranged train paths for freight trains following the procedure referred to in Article 15 of Directive 2001/14/EC recognising the need for capacity of other types of transport, including passenger transport. They shall facilitate journey times, frequencies, times of departure and destination and routings suitable for freight transport services with a view to increasing the transport of goods by freight trains running on the freight corridor. These pre-arranged train paths shall be published not later than 3 months before the final date for receipt of requests for capacity referred to in Annex III to Directive 2001/14/EC. The infrastructure managers of several freight corridors may, if necessary, coordinate international prearranged train paths offering capacity on the freight corridors concerned.

4.   These pre-arranged train paths shall be allocated first to freight trains which cross at least one border.

5.   Infrastructure managers shall, if justified by market need and the evaluation as referred to in paragraph 2 of this Article, jointly define the reserve capacity for international freight trains running on the freight corridors recognising the need for capacity of other types of transport, including passenger transport and keep this reserve available within their final working timetables to allow for a quick and appropriate response to ad hoc requests for capacity as referred to in Article 23 of Directive 2001/14/EC. This capacity shall be reserved until the time limit before its scheduled time as decided by the management board. This time limit shall not exceed 60 days.

6.   The management board shall promote coordination of priority rules relating to capacity allocation on the freight corridor.

7.   Infrastructure managers may include in their conditions of use a fee for train paths that are allocated but ultimately not used. The level of this fee shall be appropriate, dissuasive and effective.

8.   Save in the case of force majeure, including urgent and unforeseeable safety-critical work, a train path allocated to a freight operation pursuant to this Article may not be cancelled less than 2 months before its scheduled time in the working timetable if the applicant concerned does not give its approval for such cancellation. In such a case the infrastructure manager concerned shall make an effort to propose to the applicant a train path of an equivalent quality and reliability which the applicant has the right to accept or refuse. This provision shall be without prejudice to any rights the applicant may have under an agreement as referred to in Article 19(1) of Directive 2001/14/EC. In any case, the applicant may refer the matter to the regulatory body referred to in Article 20 of this Regulation.

9.   The management board of the freight corridor and the advisory group referred to in Article 8(7) shall put in place procedures to ensure optimal coordination of the allocation of capacity between infrastructure managers, both for requests as referred to in Article 13(1) and for requests received by infrastructure managers concerned. This shall also take account of access to terminals.

10.   In paragraphs 4 and 9 of this Article, references to infrastructure managers shall include, where relevant, allocation bodies as referred to in Article 14(2) of Directive 2001/14/EC.

1.   The management board of the freight corridor shall put in place procedures for coordinating traffic management along the freight corridor. The management boards of connected freight corridors shall put in place procedures for coordinating traffic along such freight corridors.

2.   The infrastructure managers of the freight corridor and the advisory group referred to in Article 8(7) shall put in place procedures to ensure optimal coordination between the operation of the railway infrastructure and the terminals.

1.   The management board shall adopt common targets for punctuality and/or guidelines for traffic management in the event of disturbance to train movements on the freight corridor.

2.   Each infrastructure manager concerned shall draw up priority rules for the management between the different types of traffic in the part of the freight corridors within the responsibility of that infrastructure manager in accordance with the common targets and/or guidelines referred to in paragraph 1 of this Article. Those priority rules shall be published in the network statement referred to in Article 3 of Directive 2001/14/EC.

3.   The principles for establishing the priority rules shall at least provide that the train path referred to in Article 14(3) and (4) allocated to freight trains which comply with their scheduled time in the working timetable shall not be modified, as far as possible. The principles for establishing the priority rules shall aim at minimising the overall network recovery time with regard to the needs of all types of transport. For this purpose, infrastructure managers may coordinate the management between the different types of traffic along several freight corridors.

1.   The management board of the freight corridor shall promote compatibility between the performance schemes along the freight corridor, as referred to in Article 11 of Directive 2001/14/EC.

2.   The management board shall monitor the performance of rail freight services on the freight corridor and publish the results of this monitoring once a year.

3.   The management board shall organise a satisfaction survey of the users of the freight corridor and shall publish the results of it once a year.

1.   The regulatory bodies referred to in Article 30 of Directive 2001/14/EC shall cooperate in monitoring the competition in the rail freight corridor. In particular, they shall ensure non-discriminatory access to the corridor and shall be the appeal bodies provided for under Article 30(2) of that Directive. They shall exchange the necessary information obtained from infrastructure managers and other relevant parties.

2.   Member States, in order to foster free and fair competition on the freight corridors, shall endeavour to establish a comparable regulatory level. Regulatory bodies shall be easily accessible to the market players, and shall be able to take decisions independently and efficiently.

3.   In the event of a complaint to a regulatory body from an applicant regarding international rail freight services, or within the framework of an own-initiative investigation by a regulatory body, this regulatory body shall consult the regulatory bodies of all other Member States through which the international train path for freight train concerned runs and request all necessary information from them before taking its decision.

4.   The regulatory bodies consulted under paragraph 3 shall provide all the information that they themselves have the right to request under their national legislation to the regulatory body concerned. This information may only be used for the purpose of the handling of the complaint or the investigation referred to in paragraph 3.

5.   The regulatory body receiving the complaint or having initiated the own-initiative investigation shall transfer relevant information to the regulatory body responsible in order for that body to take measures regarding the parties concerned.

6.   Any associated representatives of infrastructure managers as referred to in Article 15(1) of Directive 2001/14/EC shall ensure provision, without delay, of all the information necessary for the purpose of the handling of the complaint or the investigation referred to in paragraph 3 of this Article and requested by the regulatory body of the Member State in which the associated representative is located. This regulatory body shall be entitled to transfer such information regarding the international train path concerned to the regulatory bodies mentioned in paragraph 3 of this Article.

1.   The Commission shall be assisted by the Committee referred to in Article 11a of Directive 91/440/EEC.

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 3 months.

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:

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:

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:

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).

1.   Member States may, while observing the general rules laid down in the TFEU, maintain provisions in force on 9 November 2010, aimed at ensuring more extensive protection of animals falling within the scope of this Directive than those contained in this Directive.

Before 1 January 2013 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.

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.

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:

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.

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 (9), 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:

2.   Paragraph 1 shall not apply to any species of 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 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:

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).

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.

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 10 November 2017. 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 10 November 2022.

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

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:

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.

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:

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:

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:

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.

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.

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:

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.

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.

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.

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.

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.

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:

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).

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

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

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.

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

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 3 years.

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

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

2.   The records referred to in paragraph 1 shall be kept for a minimum of 5 years and made available to the competent authority upon request.

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

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 3 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.

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.

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

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.

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:

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 5 years.

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.

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.

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:

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

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:

2.   The project evaluation shall consist in particular of the following:

3.   The competent authority carrying out the project evaluation shall consider expertise in particular in the following areas:

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.

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:

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.

1.   The project authorisation shall be limited to procedures which have been subject to:

2.   The project authorisation shall specify the following:

3.   Project authorisations shall be granted for a period not exceeding 5 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.

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.

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:

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.

1.   Subject to safeguarding intellectual property and confidential information, the non-technical project summary shall provide the following:

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.

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.

1.   Member States shall ensure that all relevant documentation, including project authorisations and the result of the project evaluation is kept for at least 3 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.

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.

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).

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.

1.   The power to adopt delegated acts referred to in Article 50 shall be conferred on the Commission for a period of 8 years beginning on 9 November 2010. The Commission shall make a report in respect of the delegated power at the latest 12 months before the end of the 8-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.

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.

1.   The European Parliament or the Council may object to a delegated act within a period of 2 months from the date of notification.

At the initiative of the European Parliament or the Council this period shall be extended by 2 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.

1.   Member States shall by 10 November 2018, and every 5 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 10 November 2015 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 10 May 2012 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).

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:

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 3 months.

1.   By 10 November 2019 and every 5 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 10 November 2019 and every 3 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.

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:

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 10 February 2011, as well as any update to such data.

The Commission shall make publicly available the list of those contact points.

1.   Member States shall adopt and publish, by 10 November 2012, 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 1 January 2013.

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.

1.   Directive 86/609/EEC is repealed with effect from 1 January 2013 with the exception of Article 13, which shall be repealed with effect from 10 May 2013.

2.   References to the repealed Directive shall be construed as references to this Directive.

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 1 January 2013 and the duration of which does not extend beyond 1 January 2018.

2.   Projects which have been approved before 1 January 2013 and the duration of which extends beyond 1 January 2018 shall obtain project authorisation by 1 January 2018.