title: Directive (EU) 2017/1564 of the European Parliament and of the Council of 13 September 2017 on certain permitted uses of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled and amending Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society

text:
                  20.9.2017

                  EN

                  Official Journal of the European Union

                  L 242/6

            DIRECTIVE (EU) 2017/1564 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
      of 13 September 2017
      on certain permitted uses of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled and amending Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society
      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,
      After transmission of the draft legislative act to the national parliaments,
      Having regard to the opinion of the European Economic and Social Committee (1),
      Acting in accordance with the ordinary legislative procedure (2),
      Whereas:

                  (1)

                  Union legal acts in the area of copyright and related rights provide legal certainty and a high level of protection for rightholders, and constitute a harmonised legal framework. That framework contributes to the proper functioning of the internal market and stimulates innovation, creation, investment and the production of new content, including in the digital environment. It also aims to promote access to knowledge and culture by protecting works and other subject matter and by permitting exceptions or limitations that are in the public interest. A fair balance of rights and interests between rightholders and users should be safeguarded.

                  (2)

                  Directives 96/9/EC (3), 2001/29/EC (4), 2006/115/EC (5) and 2009/24/EC (6) of the European Parliament and of the Council harmonise the rights of rightholders in the area of copyright and related rights. Those Directives, together with Directive 2012/28/EU of the European Parliament and of the Council (7), provide for an exhaustive list of exceptions and limitations to those rights, which allow the use of content without the rightholders' authorisation under certain conditions in order to achieve certain policy objectives.

                  (3)

                  Persons who are blind, visually impaired or otherwise print-disabled continue to face many barriers to accessing books and other printed material which are protected by copyright and related rights. Taking into consideration the rights of blind, visually impaired or otherwise print-disabled persons as recognised in the Charter of Fundamental Rights of the European Union (the ‘Charter’) and the United Nations Convention on the Rights of Persons with Disabilities (the ‘UNCRPD’), measures should be taken to increase the availability of books and other printed material in accessible formats, and to improve their circulation in the internal market.

                  (4)

                  The Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired, or Otherwise Print Disabled (the ‘Marrakesh Treaty’) was signed on behalf of the Union on 30 April 2014 (8). Its aim is to improve the availability and cross-border exchange of certain works and other protected subject matter in accessible formats for persons who are blind, visually impaired or otherwise print-disabled. The Marrakesh Treaty requires contracting parties to provide for exceptions or limitations to copyright and related rights for the making and dissemination of copies, in accessible formats, of certain works and other protected subject matter, and for the cross-border exchange of those copies. The conclusion of the Marrakesh Treaty by the Union requires the adaptation of Union law by establishing a mandatory and harmonised exception for uses, works and beneficiary persons covered by that treaty.

                  (5)

                  According to Opinion 3/15 of the Court of Justice of the European Union (9), the exceptions or limitations to copyright and related rights for the making and dissemination of copies, in accessible formats, of certain works and other subject matter, provided for by the Marrakesh Treaty, have to be implemented within the field harmonised by Directive 2001/29/EC.

                  (6)

                  This Directive implements the obligations that the Union has to meet under the Marrakesh Treaty in a harmonised manner, with a view to ensuring that the corresponding measures are applied consistently throughout the internal market. This Directive should therefore provide for a mandatory exception to the rights that are harmonised by Union law and are relevant for the uses and works covered by the Marrakesh Treaty. Such rights include, in particular, the rights of reproduction, communication to the public, making available to the public, distribution and lending, as provided for in Directives 2001/29/EC, 2006/115/EC and 2009/24/EC, as well as the corresponding rights provided for in Directive 96/9/EC. As the scope of the exceptions or limitations required by the Marrakesh Treaty also includes works in audio form, like audiobooks, the mandatory exception provided for under this Directive should also apply to related rights.

                  (7)

                  This Directive concerns persons who are blind, persons who have a visual impairment which cannot be improved so as to give them visual function substantially equivalent to that of a person who has no such impairment, persons who have a perceptual or reading disability, including dyslexia or any other learning disability preventing them from reading printed works to substantially the same degree as persons without such disability, and persons who are unable, due to a physical disability, to hold or manipulate a book or to focus or move the eyes to the extent that would be normally acceptable for reading, insofar as, as a result of such impairments or disabilities, those persons are unable to read printed works to substantially the same degree as persons without such impairments or disabilities. This Directive therefore aims to improve the availability of books, including e-books, journals, newspapers, magazines and other kinds of writing, notation, including sheet music, and other printed material, including in audio form, whether digital or analogue, online or offline, in formats that make those works and other subject matter accessible to those persons to substantially the same degree as to persons without such impairment or disability. Accessible formats include, for example, Braille, large print, adapted e-books, audio books and radio broadcasts.

                  (8)

                  The mandatory exception provided for in this Directive should limit the right of reproduction so as to allow for any act that is necessary in order to make changes to or convert or adapt a work or other subject matter in such a way as to produce an accessible format copy that makes it possible for beneficiary persons to access that work or other subject matter. This includes providing the necessary means to navigate information in an accessible format copy. It also includes changes that might be required in cases in which the format of a work or of other subject matter is already accessible to certain beneficiary persons while it might not be accessible to other beneficiary persons, due to different impairments or disabilities, or the different degree of such impairments or disabilities.

                  (9)

                  The permitted uses laid down in this Directive should include the making of accessible format copies by either beneficiary persons or authorised entities serving their needs, whether those authorised entities be public or private organisations, in particular libraries, educational establishments and other non-profit organisations, that serve persons with a print disability as one of their primary activities, institutional obligations or as part of their public interest missions. The uses laid down in this Directive should also include the making of accessible format copies, for the exclusive use of beneficiary persons, by a natural person who does so on behalf of a beneficiary person or who assists the beneficiary person making such copies. Accessible format copies should only be made of works or other subject matter to which beneficiary persons or authorised entities have lawful access. Member States should ensure that any contractual provision which seeks to prevent or limit the application of the exception in any way is void of legal effect.

                  (10)

                  The exception provided for in this Directive should allow authorised entities to make and disseminate, online and offline within the Union, accessible format copies of works or other subject matter covered by this Directive. This Directive should not impose an obligation on authorised entities to make and disseminate such copies.

                  (11)

                  It should be possible for accessible format copies made in one Member State to be available in all Member States, in order to ensure their greater availability across the internal market. This would reduce the demand for duplication of work in producing accessible format copies of one and the same work or other subject matter across the Union, thus generating savings and efficiency gains. This Directive should therefore ensure that accessible format copies made by authorised entities in any Member State can be circulated and accessed by beneficiary persons and authorised entities throughout the Union. In order to foster such cross-border exchange and to facilitate authorised entities' mutual identification and cooperation, the voluntary sharing of information regarding the names and contact details of authorised entities established in the Union, including websites if available, should be encouraged. Member States should therefore provide the information received from authorised entities to the Commission. This should not imply an obligation for Member States to check the completeness and accuracy of such information or its compliance with their national law transposing this Directive. Such information should be made available online by the Commission on a central information access point at Union level. This would also assist authorised entities, as well as beneficiary persons and rightholders in contacting authorised entities to receive further information, in line with the provisions set out in this Directive and in Regulation (EU) 2017/1563 of the European Parliament and of the Council (10). The aforementioned central information access point should be complementary to the information access point to be established by the International Bureau of the World Intellectual Property Organisation (WIPO), as provided for in the Marrakesh Treaty, aiming to facilitate the identification of, and cooperation among, authorised entities at international level.

                  (12)

                  In order to improve the availability of accessible format copies and to prevent the unauthorised dissemination of works or other subject matter, authorised entities which engage in the distribution, communication to the public or making available to the public of accessible format copies should comply with certain obligations.

                  (13)

                  Authorisation or recognition requirements that Member States may apply to authorised entities, such as those relating to the provision of services of a general nature to beneficiary persons, should not have the effect of preventing entities that are covered by the definition of authorised entity under this Directive from undertaking the uses allowed under this Directive.

                  (14)

                  In view of the specific nature of the exception provided for under this Directive, its specific scope and the need for legal certainty for its beneficiaries, Member States should not be allowed to impose additional requirements for the application of the exception, such as the prior verification of the commercial availability of works in accessible formats, other than those laid down in this Directive. Member States should only be allowed to provide for compensation schemes regarding the permitted uses of works or other subject matter by authorised entities. In order to avoid burdens for beneficiary persons, prevent barriers to the cross-border dissemination of accessible format copies and excessive requirements on authorised entities, it is important that the possibility for Member States to provide for such compensation schemes be limited. Consequently, compensation schemes should not require payments by beneficiary persons. They should only apply to uses by authorised entities established in the territory of the Member State providing for such a scheme, and they should not require payments by authorised entities established in other Member States or third countries that are parties to the Marrakesh Treaty. Member States should ensure that there are not more burdensome requirements for the cross-border exchange of accessible format copies under such compensation schemes than for non-cross border situations, including with regard to the form and possible level of compensation. When determining the level of compensation, due account should be taken of the non-profit nature of the activities of authorised entities, of the public interest objectives pursued by this Directive, of the interests of beneficiaries of the exception, of the possible harm to rightholders and of the need to ensure cross-border dissemination of accessible format copies. Account should also be taken of the particular circumstances of each case, resulting from the making of a particular accessible format copy. Where the harm to a rightholder is minimal, no obligation for payment of compensation should arise.

                  (15)

                  It is essential that any processing of personal data under this Directive respect fundamental rights, including the right to respect for private and family life and the right to protection of personal data under Articles 7 and 8 of the Charter, and it is imperative that any such processing also be in compliance with Directives 95/46/EC (11) and 2002/58/EC (12) of the European Parliament and of the Council, which govern the processing of personal data, as may be carried out by authorised entities within the framework of this Directive and under the supervision of the Member States' competent authorities, in particular the public independent authorities designated by the Member States.

                  (16)

                  The UNCRPD, to which the Union is a party, guarantees persons with disabilities the right of access to information and education and the right to participate in cultural, economic and social life, on an equal basis with others. The UNCRPD requires parties to the Convention to take all appropriate steps, in accordance with international law, to ensure that laws protecting intellectual property rights do not constitute an unreasonable or discriminatory barrier to access by persons with disabilities to cultural materials.

                  (17)

                  Under the Charter, all forms of discrimination, including on grounds of disability, are prohibited and the right of persons with disabilities to benefit from measures designed to ensure their independence, social and occupational integration and participation in the life of the community is recognised and respected by the Union.

                  (18)

                  With the adoption of this Directive, the Union aims to ensure that beneficiary persons have access to books and other printed material in accessible formats across the internal market. Accordingly, this Directive is an essential first step in improving access to works for persons with disabilities.

                  (19)

                  The Commission should assess the situation regarding the availability in accessible formats of works and other subject matter other than those covered by this Directive, as well as the availability of works and other subject matter in accessible formats for persons with other disabilities. It is important that the Commission review the situation in that regard closely. Changes to the scope of this Directive could be considered, if necessary, on the basis of a report presented by the Commission.

                  (20)

                  Member States should be allowed to continue to provide for an exception or limitation for the benefit of persons with a disability in cases which are not covered by this Directive, in particular as regards works and other subject matter and disabilities other than those covered by this Directive, pursuant to point (b) of Article 5(3) of Directive 2001/29/EC. This Directive does not prevent Member States from providing for exceptions or limitations to rights that are not harmonised in the copyright framework of the Union.

                  (21)

                  This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter and the UNCRPD. This Directive should be interpreted and applied in accordance with those rights and principles.

                  (22)

                  The Marrakesh Treaty imposes certain obligations regarding the exchange of accessible format copies between the Union and third countries that are parties to that Treaty. The measures taken by the Union to fulfil those obligations are contained in Regulation (EU) 2017/1563 which should be read in conjunction with this Directive.

                  (23)

                  Since the objective of this Directive, namely to improve access in the Union to works and other subject matter protected by copyright and related rights for persons who are blind, visually impaired or otherwise print-disabled, cannot be sufficiently achieved by the Member States but can rather, 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 the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (13), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified,

            HAVE ADOPTED THIS DIRECTIVE:
      Article 1
      Subject matter and scope
      This Directive aims to further harmonise Union law applicable to copyright and related rights in the framework of the internal market, by establishing rules on the use of certain works and other subject matter without the authorisation of the rightholder, for the benefit of persons who are blind, visually impaired or otherwise print-disabled.
      Article 2
      Definitions
      For the purposes of this Directive the following definitions apply:

                  (1)

                  ‘work or other subject matter’ means a work in the form of a book, journal, newspaper, magazine or other kind of writing, notation, including sheet music, and related illustrations, in any media, including in audio form such as audiobooks and in digital format, which is protected by copyright or related rights and which is published or otherwise lawfully made publicly available;

                  (2)

                  ‘beneficiary person’ means, regardless of any other disabilities, a person who:

                              (a)

                              is blind;

                              (b)

                              has a visual impairment which cannot be improved so as to give the person visual function substantially equivalent to that of a person who has no such impairment, and who is, as a result, unable to read printed works to substantially the same degree as a person without such an impairment;

                              (c)

                              has a perceptual or reading disability and is, as a result, unable to read printed works to substantially the same degree as a person without such disability; or

                              (d)

                              is otherwise unable, due to a physical disability, to hold or manipulate a book or to focus or move their eyes to the extent that would be normally acceptable for reading.

                  (3)

                  ‘accessible format copy’ means a copy of a work or other subject matter in an alternative manner or form that gives a beneficiary person access to the work or other subject matter, including allowing such person to have access as feasibly and comfortably as a person without any of the impairments or disabilities referred to in point 2;

                  (4)

                  ‘authorised entity’ means an entity that is authorised or recognised by a Member State to provide education, instructional training, adaptive reading or information access to beneficiary persons on a non-profit basis. It also includes a public institution or non-profit organisation that provides the same services to beneficiary persons as one of its primary activities, institutional obligations or as part of its public-interest missions.

            Article 3
      Permitted uses
      1.   Member States shall provide for an exception to the effect that no authorisation of the rightholder of any copyright or related right in a work or other subject matter is required pursuant to Articles 5 and 7 of Directive 96/9/EC, Articles 2, 3 and 4 of Directive 2001/29/EC, Article 1(1), Article 8(2) and (3) and Article 9 of Directive 2006/115/EC and Article 4 of Directive 2009/24/EC for any act necessary for:

                  (a)

                  a beneficiary person, or a person acting on their behalf, to make an accessible format copy of a work or other subject matter to which the beneficiary person has lawful access for the exclusive use of the beneficiary person; and

                  (b)

                  an authorised entity to make an accessible format copy of a work or other subject matter to which it has lawful access, or to communicate, make available, distribute or lend an accessible format copy to a beneficiary person or another authorised entity on a non-profit basis for the purpose of exclusive use by a beneficiary person.

            2.   Member States shall ensure that each accessible format copy respects the integrity of the work or other subject matter, with due consideration given to the changes required to make the work or other subject matter accessible in the alternative format.
      3.   The exception provided for in paragraph 1 shall only be applied in certain special cases which do not conflict with a normal exploitation of the work or other subject matter and do not unreasonably prejudice the legitimate interests of the rightholder.
      4.   The first, third and fifth subparagraphs of Article 6(4) of Directive 2001/29/EC shall apply to the exception provided for in paragraph 1 of this Article.
      5.   Member States shall ensure that the exception provided for in paragraph 1 cannot be overridden by contract.
      6.   Member States may provide that uses permitted under this Directive, if undertaken by authorised entities established in their territory, be subject to compensation schemes within the limits provided for in this Directive.
      Article 4
      Accessible format copies in the internal market
      Member States shall ensure that an authorised entity established in their territory may carry out the acts referred to in point (b) of Article 3(1) for a beneficiary person or another authorised entity established in any Member State. Member States shall also ensure that a beneficiary person or an authorised entity established in their territory may obtain or may have access to an accessible format copy from an authorised entity established in any Member State.
      Article 5
      Obligations of authorised entities
      1.   Member States shall provide that an authorised entity established in their territory carrying out the acts referred to in Article 4 establishes and follows its own practices to ensure that it:

                  (a)

                  distributes, communicates and makes available accessible format copies only to beneficiary persons or other authorised entities;

                  (b)

                  takes appropriate steps to discourage the unauthorised reproduction, distribution, communication to the public or making available to the public of accessible format copies;

                  (c)

                  demonstrates due care in, and maintains records of, its handling of works or other subject matter and of accessible format copies thereof; and

                  (d)

                  publishes and updates, on its website if appropriate, or through other online or offline channels, information on how it complies with the obligations laid down in points (a) to (c).

            Member States shall ensure that the practices referred to in the first subparagraph are established and followed in full respect of the rules applicable to the processing of personal data of beneficiary persons referred to in Article 7.
      2.   Member States shall ensure that an authorised entity established in their territory carrying out the acts referred to in Article 4 provides the following information in an accessible way, on request, to beneficiary persons, other authorised entities or rightholders:

                  (a)

                  the list of works or other subject matter for which it has accessible format copies and the available formats; and

                  (b)

                  the name and contact details of the authorised entities with which it has engaged in the exchange of accessible format copies pursuant to Article 4.

            Article 6
      Transparency and exchange of information
      1.   Member States shall encourage authorised entities established in their territory carrying out the acts referred to in Article 4 of this Directive and Articles 3 and 4 of Regulation (EU) 2017/1563 to communicate to them, on a voluntary basis, their names and contact details.
      2.   Member States shall provide the information they have received pursuant to paragraph 1 to the Commission. The Commission shall make such information publicly available online on a central information access point and keep it up to date.
      Article 7
      Protection of personal data
      The processing of personal data carried out within the framework of this Directive shall be carried out in compliance with Directives 95/46/EC and 2002/58/EC.
      Article 8
      Amendment to Directive 2001/29/EC
      In Article 5(3) of Directive 2001/29/EC, point (b) is replaced by the following:

                     ‘(b)

                     uses, for the benefit of people with a disability, which are directly related to the disability and of a non-commercial nature, to the extent required by the specific disability, without prejudice to the obligations of Member States under Directive (EU) 2017/1564 of the European Parliament and of the Council (*1);

      Article 9
      Report
      By 11 October 2020, the Commission shall present a report to the European Parliament, the Council and the European Economic and Social Committee on the availability, in accessible formats, of works and other subject matter other than those defined in point 1 of Article 2 for beneficiary persons, and of works and other subject matter for persons with disabilities other than those referred to in point 2 of Article 2, in the internal market. The report shall take into account developments concerning relevant technology and shall contain an assessment of the appropriateness of broadening the scope of this Directive in order to improve access to other types of works and other subject matter and to improve access for persons with disabilities other than those covered by this Directive.
      Article 10
      Review
      1.   By 11 October 2023, the Commission shall carry out an evaluation of this Directive and present the main findings in a report to the European Parliament, the Council and the European Economic and Social Committee, accompanied, where appropriate, by proposals for amending this Directive. Such evaluation shall include an assessment of the impact of compensation schemes, provided for by Member States pursuant to Article 3(6), on the availability of accessible format copies for beneficiary persons and on their cross-border exchange. The Commission's report shall take into account the views of relevant civil society actors and of non-governmental organisations, including organisations representing persons with disabilities and those representing older persons.
      2.   Member States shall provide the Commission with the necessary information for the preparation of the report referred to in paragraph 1 of this Article and the preparation of the report referred to in Article 9.
      3.   A Member State that has valid reasons to consider that the implementation of this Directive has had a significant negative impact on the commercial availability of works or other subject matter in accessible formats for beneficiary persons may bring the matter to the attention of the Commission providing all relevant evidence. The Commission shall take that evidence into account when drawing up the report referred to in paragraph 1.
      Article 11
      Transposition
      1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 11 October 2018. They shall immediately inform the Commission thereof.
      When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.
      2.   Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.
      Article 12
      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.
      Article 13
      Addressees
      This Directive is addressed to the Member States.

         Done at Strasbourg, 13 September 2017.

               For the European Parliament

               The President

            A. TAJANI

               For the Council

               The President

            M. MAASIKAS

         (1)  OJ C 125, 21.4.2017, p. 27.

         (2)  Position of the European Parliament of 6 July 2017 (not yet published in the Official Journal) and decision of the Council of 17 July 2017.

         (3)  Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases (OJ L 77, 27.3.1996, p. 20).

         (4)  Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (OJ L 167, 22.6.2001, p. 10).

         (5)  Directive 2006/115/EC of the European Parliament and of the Council of 12 December 2006 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (OJ L 376, 27.12.2006, p. 28).

         (6)  Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs (OJ L 111, 5.5.2009, p. 16).

         (7)  Directive 2012/28/EU of the European Parliament and of the Council of 25 October 2012 on certain permitted uses of orphan works (OJ L 299, 27.10.2012, p. 5).

         (8)  Council Decision 2014/221/EU of 14 April 2014 on the signing, on behalf of the European Union, of the Marrakesh Treaty to Facilitate Access to Published Works for Persons who are Blind, Visually Impaired, or otherwise Print Disabled (OJ L 115, 17.4.2014, p. 1).

         (9)  Opinion of the Court of Justice of 14 February 2017, 3/15, ECLI:EU:C:2017:114, paragraph 112.

         (10)  Regulation (EU) 2017/1563 of the European Parliament and of the Council of 13 September 2017 on the cross-border exchange between the Union and third countries of accessible format copies of certain works and other subject matter protected by copyright and related rights for the benefit of persons who are blind, visually impaired or otherwise print-disabled (see page 1 of this Official Journal).

         (11)  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 (OJ L 281, 23.11.1995, p. 31). That Directive will be repealed and replaced, with effect from 25 May 2018, by Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

         (12)  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 (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

         (13)  OJ C 369, 17.12.2011, p. 14.


Avis juridique important

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31993L0053

Council Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases

Official Journal L 175 , 19/07/1993 P. 0023 - 0033 Finnish special edition: Chapter 3 Volume 53 P. 0140  Swedish special edition: Chapter 3 Volume 53 P. 0140

COUNCIL DIRECTIVE 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseasesTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas fish are listed in Annex II to the Treaty; whereas the marketing of fish constitutes an important source of revenue for the aquaculture sector;  Whereas it is necessary to establish at Community level the control measures to be taken in the event of outbreaks of disease, in order to ensure rational development of the aquaculture sector and to contribute to the protection of animal health in the  Community;  Whereas it is necessary, for diseases to be covered, to refer to the lists laid down in Annex A to Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and  products (4);  Whereas an outbreak of such diseases can quickly take on epizootic proportions, causing mortality and disturbances on a scale liable to reduce severely the profitability of aquaculture;  Whereas control measures must be taken as soon as the presence of such a disease is suspected so that immediate and effective action can be implemented as soon as its presence is confirmed;  Whereas such measures must be aimed at preventing the spread of the disease, in particular by carefully controlling movements of fish and products liable to spread the infection;  Whereas the prevention of diseases in the Community must normally be based on a non-vaccination policy;  Whereas a thorough epizootiological investigation is essential to prevent any spread of the diseases; whereas the Member States must establish special units for that purpose;  Whereas, in order to ensure an effective system of control, diagnosis of the diseases must be harmonized and carried out under the auspices of responsible laboratories, the coordination of which may be carried out by a reference laboratory designated by  the Community;  Whereas, in order to ensure uniform implementation of this Directive, a Community inspection procedure should be established;  Whereas common measures for the control of the diseases form a minimum basis for maintaining a uniform standard of animal health;  Whereas Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (5), and in particular Article 5 thereof, applies in the event of an outbreak of one of the diseases listed in Annex A to Directive 91/67/EEC;  Whereas the Commission should be entrusted with the task of adopting the necessary implementing measures; whereas, for that purpose, a procedure should be established to bring about close and effective cooperation between the Commission and the Member  States within the Standing Veterinary Committee,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I General provisions   Article 1  This Directive defines the minimum Community measures for the control of the fish diseases referred to in Annex A, lists I and II, to Directive 91/67/EEC.  Article 2  For the purposes of this Directive, the definitions laid down in Article 2 of Directive 91/67/EEC shall apply as necessary.  In addition, the following definitions shall apply:  1. list I diseases: fish diseases referred to in Annex A, list I, to Directive 91/67/EEC;  2. list II diseases: fish diseases referred to in Annex A, list II, to Directive 91/67/EEC;  3. fish suspected of being infected: fish showing clinical signs or post-mortem lesions or dubious reactions in laboratory tests giving rise to reasonable suspicion of the presence of a list I or list II disease;  4. infected fish: fish in which the presence of a list I or list II disease has been officially confirmed as the result of a laboratory examination or, in the case of ISA, as the result of a clinical examination and a post-mortem examination;  5. farm suspected of being infected: farm containing fish suspected of being infected;  6. infected farm: farm containing infected fish; also farm which has been evacuated but not yet disinfected.  Article 3  Member States shall ensure that all farms rearing or keeping fish susceptible to list I or list II diseases:  1. are registered by the official service; this registration must be kept constantly up to date;  2. keep a record of:  (a) live fish, eggs and gametes entering the farm, containing all information relating to their delivery, their number or weight, their size, their source and their suppliers;  (b) live fish, eggs and gametes leaving the farm, containing all information relating to their dispatch, their number or weight, their size and destination;  (c) observed mortality.  This record, which shall be open to scrutiny by the official service whenever the latter so requests, must be regularly updated and shall be kept for four years.  Article 4  Member States shall ensure that it is compulsory for the suspected presence of any of the list I and list II diseases to be notified as soon as possible to the official service.  CHAPTER II Control measures for list I diseases   Article 5  1. When fish on a farm are suspected of being infected with a list I disease, Member States shall ensure that the official service immediately activates official investigation arrangements to confirm or rule out the presence of the disease, including  clinical examination; in particular, it must take, or have taken, the samples necessary for laboratory examination.  2. As soon as the suspected presence of the disease is notified, the official service shall have the farm placed under official surveillance and shall in particular require that:  (a) an official census be made of all species and categories of fish and that, in respect of each of these, the number of fish already dead, infected or suspected of being infected or contaminated be recorded; the census must be kept up to date by the  owner or keeper to take account of the increase in the population or new mortality observed during the period of suspected infection; the information in the census must be produced on request and may be checked at each inspection;  (b) no fish, whether alive or dead, or eggs or gametes enter or leave the farm without the authorization of the official service;  (c) the disposal of dead fish or their offal be carried out under the supervision of the official service;  (d) the entry or exit of feedingstuffs, utensils, objects or other substances such as waste, liable to transmit disease be subject, if necessary, to authorization by the official service, which shall lay down the conditions required to prevent the  spread of the pathogen;  (e) the movement of persons to or from the farm be made subject to authorization by the official service;  (f) the entry or exit of vehicles to or from the farm be made subject to authorization by the official service, which shall lay down the conditions required to prevent the spread of the pathogen;  (g) appropriate means of disinfection be used at the entrances end exits of the farm;  (h) an epizootic investigation be carried out in accordance with Article 8 (1);  (i) all of the farms situated in the same water catchment area or coastal area be placed under official surveillance, and no fish, eggs or gametes leave these farms without the authorization of the official service; in the case of extensive water  catchment areas or coastal areas, the official service may decide to limit this measure to a less extensive area close to the farm suspected of being infected, if it considers that this area affords maximum guarantees for the prevention of the spread of  the disease;  if necessary, the official services of neighbouring Member States or third countries must be informed of the suspected case; in that event, the official services of the Member States involved shall take appropriate action to apply the measures laid down  in this Article.  Where necessary, specific measures may be taken in accordance with the procedure laid down in Article 19.  3. Until such time as the official measures laid down in paragraph 2 are enforced, the owner or keeper of any fish in which disease is suspected shall take every appropriate measure to ensure compliance with paragraph 2, except for (h) and (i) thereof.   4. The measures referred to in paragraph 2 shall not be withdrawn until the suspicion of disease has been officially ruled out.  Article 6  As soon as the presence of a list I disease has been officially confirmed, Member States shall ensure that the official service orders that, in addition to the measures listed in Article 5 (2), of the following measures be applied:  (a) in an infected farm:  - all fish must be immediately withdrawn,  - in the case of inland farms all pools must be drained for the purposes of cleaning and disinfection,  - all eggs and gametes, dead fish and fish showing clinical signs of disease shall be regarded as high-risk material and must be destroyed under the supervision of the official service, in accordance with Directive 90/667/EEC (6),  - all live fish shall either be killed and destroyed under the supervision of the official service in accordance with Directive 90/667/EEC, or else, in the case of fish which have reached commercial size and show no clinical sign of disease, be  slaughtered under the supervision of the official service for marketing or processing for human consumption.  In the latter case, the official service shall ensure that the fish are immediately slaughtered and gutted, that these operations are carried out in conditions such as to prevent the spread of pathogens, that the fish waste and offal are regarded as  high-risk material and are submitted to a treatment to destroy pathogens in accordance with Directive 90/667/EEC and that the used water is submitted to a treatment which inactivates any pathogens it may contain;  - after removal of the fish, eggs and gametes, ponds, equipment and any material liable to be contaminated must be cleaned and disinfected as soon as possible following the instructions established by the official service in such a way as to eliminate  any risk of the agent of the disease spreading or surviving. The procedures for cleaning and disinfecting an infected farm shall be determined in accordance with the procedure laid down in Article 19,  - any substances which might be contaminated, referred to in Article 5 (2) (d), must be destroyed or treated in such a way as to ensure the destruction of any pathogen present,  - an epizootic investigation must be carried out in accordance with Article 8 (1) and the provisions of Article 8 (4) must be applied; this investigation must include the taking of samples for laboratory examination;  (b) all farms situated in the water catchment area or in the coastal zone in which the infected farm is situated shall undergo health inspections; if these inspections reveal positive cases, the measures provided for under (a) of this paragraph shall be  applied;  (c) the repopulation of the farm shall be authorized by the official service following satisfactory inspection of the cleaning and disinfection operations and at the end of a period deemed adequate by the official service to ensure eradication of the  pathogen, and of other possible infections in the same water catchment area;  (d) it application of the measures laid down under (a), (b), (c) and (d) of Article 5 (2) requires the cooperation of the official services of other Member States, the official services of the Member States concerned shall collaborate to ensure  compliance with the measures laid down in this Article.  Where necessary, appropriate additional measures shall be adopted in accordance with the procedure laid down in Article 19.  Article 7  Where fish from the wild and not belonging to any farm or fish in lakes, ponds or other installations intended for angling or holding ornamental fish are infected or suspected of being infected, Member States shall ensure that appropriate measures are  taken. Member States shall inform the Commission and the other Member States, in the Standing Veterinary Committee, of the measures they have taken.  Article 8  1. The epizootic investigation shall deal with:  - the likely length of time during which the disease may have existed on the farm before being notified or suspected,  - the possible origin of the disease on the farm and the identification of other farms on which there are eggs and gametes and fish of susceptible species which may have become infected;  - the movement of fish, eggs or gametes, vehicles or substances and persons likely to have carried the agent of the disease to or from the farms in question,  - the possible existence of carriers of the disease, and their distribution.  2. If the epizootic investigation reveals that the disease could have been introduced from another water catchment area or another coastal area, or could have been transferred to another water catchment area or another coastal area as a result of a  contact arising from the movement of fish, eggs or gametes, animals, vehicles or persons, or in any other way, the farms belonging to such water catchment areas and coastal areas shall be considered suspect and the measures laid down in Article 5 shall  apply. If the presence of the disease is confirmed, the measures laid down in Article 6 shall apply.  3. If the epizootic investigation reveals that the cooperation of the official services of other Member States is required, the official services of the Member States concerned shall take all necessary measures to ensure compliance with the provisions  of this Directive.  4. A crisis unit shall be established in order to provide full coordination of all measures necessary to ensure eradication of the disease as quickly as possible and for the purpose of carrying out the epizootic investigation.  The general rules concerning national crisis units and the Community crisis units shall be laid down by the Council, acting by a qualified majority on a proposal from the Commission.  5. The Council, acting by a qualified majority on a proposal from the Commission drawn up on the basis of the opinion of the Scientific Veterinary Committee to take account, in particular, of scientific and technological developments, shall review the  provisions of this Article before 31 December 1996.  CHAPTER III Control measures for list II diseases   Article 9  1. Where a list II disease is suspected and/or confirmed in an approved zone or on an approved farm situated in a non-approved zone, an epizootic investigation shall be carried out in accordance with Article 8. Member States wishing to regain their  status defined in accordance with Directive 91/67/EEC must comply with the provisions of Annexes B and C to that Directive.  2. If the epizootic investigation reveals that the disease could have been introduced from an approved zone or from another approved farm, or could have been transferred to another approved farm as a result of the movement of fish, eggs or gametes,  vehicles or persons, or in any other way, those zones or farms shall be considered suspect and the appropriate measures shall apply.  3. The official service may, however, authorize the fattening of fish to be slaughtered until they reach commercial size.  Article 10  1. Where a non-approved farm situated in a non-approved zone contains fish suspected of being infected with a list II disease, Member States shall ensure that the official service:  (a) immediately sets in motion official means of investigation to confirm or rule out the presence of the disease including, where necessary, the taking of samples for examination in an approved laboratory;  (b) carries out or causes to be carried out an official census of the infected farms, this census being regularly updated;  (c) places, or causes to be placed, the infected farms under official supervision, in order to ensure that, by way of derogation from Article 3 (1) (c) of Directive 91/67/EEC, the only movements authorized from infected farms are live fish or eggs or  gametes intended either for other farms infected by the same disease or for slaughter for human consumption.  2. Member States may, for a fixed period, set up under the supervision of the official service an optional or compulsory programme for the eradication of list II diseases in non-approved farms or in non-approved zones. During this period, the  introduction into a zone or farm subject to such a programme of live fish, eggs or gametes from infected farms or farms of unknown health status shall be forbidden.  These programmes, which will be set up on the basis of general criteria to be determined before the date specified in Article 20 in accordance with the procedure laid down in Article 19, will be submitted to the Commission for scrutiny, and approved and  where necessary amended in accordance with that same procedure.  After the period referred to in the first subparagraph, Member States which have recourse to this procedure shall inform the Commission and the other Member States, within the Standing Veterinary Committee, of the results obtained.  3. By 31 December 1996, the Commission shall submit to the Council a report, drawn up after obtaining the opinion of the Scientific Veterinary Committee, taking into account experience gained and scientific and technical developments and accompanied,  where appropriate, by proposals for a review of the provision of this Article, in particular with regard to the placing on the market of infected live fish, and their eggs or gametes, intended for farming or fattening, and with regard to the carrying  out of an epizootiological investigation in non-approved zones where a disease is suspected on a non-approved farm. The Council shall act by a qualified majority on any such proposals and the latter shall be put forward taking into account the  conclusions of the report.  4. Any detailed rules for implementing paragraphs 1 and 2 shall be adopted by the Commission, as and when required, in accordance with the procedure laid down in Article 19.  CHAPTER IV Final provisions   Article 11  1. Sampling and laboratory testing for the presence of list I and list II diseases shall be carried out using the methods established in accordance with Article 15 of Directive 91/67/EEC.  2. Testing for the presence of disease or pathogens shall be carried out by a laboratory approved by the official service. Laboratory testing shall, if necessary and especially on the first appearance of the disease, identify the type, sub-type or the  variant of the relevant pathogen, which must be confirmed by the national reference laboratory and may be confirmed, if necessary, by the Community reference laboratory referred to in Article 13.  Article 12  1. Member States shall ensure that in each Member State a national reference laboratory is designated, with facilities and expert personnel enabling it to show at all times, and especially when the disease in question first appears, the type, sub-type  and variant of the relevant pathogen and to confirm results obtained by regional diagnostic laboratories.  2. The national laboratories designated for the diseases in question shall be responsible for coordinating diagnostic standards and methods, and for the use of reagents.  3. The national laboratories designated for the diseases in question shall be responsible for coordinating the diagnostic standards and methods laid down by each laboratory for diagnosis of the disease in question within the Member State. To this end,  they:  (a) may provide diagnostic reagents to laboratories approved by the Member State;  (b) shall control the quality of all diagnostic reagents used in the Member State;  (c) shall periodically arrange comparative tests;  (d) shall hold isolates of the pathogen of the disease from cases confirmed in the Member State;  (e) shall ensure confirmation of positive results obtained in diagnostic laboratories approved by the Member State.  4. However, by way of derogation from paragraph 1, Member States which do not have a national laboratory competent as regards the disease in question may use the services of a national laboratory with competence in the matter in another Member State.  5. The list of national reference laboratories for fish diseases is set out in Annex A.  6. The national laboratories designated for the diseases referred to shall cooperate with the Community reference laboratory referred to in Article 13.  7. The detailed rules for implementing this Article shall be adopted by the Commission under the procedure laid down in Article 19.  Article 13  1. The Community reference laboratory for fish diseases is indicated in Annex B.  2. Without prejudice to Decision 90/424/EEC, and in particular Article 28 thereof, the functions and duties of the laboratory referred to in paragraph 1 of this Article shall be those laid down in Annex C.  Article 14  1. Vaccination against list II diseases in approved zones or in approved farms situated in non-approved zones, in zones or farms which have already begun the approval procedures laid down by Directive 91/67/EEC, and against list I diseases, shall be  forbidden.  2. The Council, acting by a qualified majority on a proposal from the Commission, shall by 30 June 1996, review the provisions of this Article, in particular with regard to laying down specific conditions for the use of vaccines and to take account of  developments in scientific and technological research into vaccination.  Article 15  1. Each Member State shall draw up a contingency plan specifying how it will implement the measures laid down in this Directive in the event of an outbreak of a list I disease.  This plan must allow access to facilities, equipment, personnel and all other appropriate structures necessary for the rapid and efficient eradication of the outbreak.  2. The general criteria to be applied for drawing up those plans are set out in Annex D.  Member States may, however, confine themselves to the application of the criteria specific to the diseases concerned, where the general criteria have already been adopted in the context of the submission of plans relating to the application of measures  for the control of another disease.  The Commission may, in accordance with the procedure laid down in Article 19, amend or supplement those criteria, taking into account the specific nature of the disease.  3. Plans drawn up in accordance with the criteria set out in Annex D shall be submitted to the Commission no later than six month after the date on which this Directive is brought into effect.  4. The Commission shall examine the plans in order to determine whether they permit the desired objective to be attained and shall suggest to the Member State concerned any amendments required, in particular to ensure that they are compatible with the  plans of the other Member States.  The Commission shall approve the plans, amended if necessary, in accordance with the procedure laid down in Article 19.  The plans may subsequently be amended or supplemented, in accordance with the same procedure, to take into account developments in the situation.  Article 16  Commission experts may, in collaboration with the competent authorities, and in so far as is necessary to ensure uniform application of this Directive, make on-the-spot checks. In order to do that, they may check a representative percentage of holdings  to see whether the competent authorities are checking that these holdings are fulfilling the requirements of this Directive. The Commission shall inform the Member States of the result of the checks carried out.  A Member State in whose territory a check is being carried out shall give all the necessary assistance to the experts in carrying out their duties.  The detailed rules for implementing this Article shall be determined in accordance with the procedure laid down in Article 19.  Article 17  The conditions governing the Community's financial contribution to the measures connected with the application of this Directive are laid down in Decision 90/424/EEC.  Article 18  Annexes B, C and D shall be amended, as and when required, by the Council acting by a qualified majority on a proposal from the Commission, in particular in order to take into account developments in research and in diagnostic procedures.  Annex A may be amended as and when required in accordance with the procedure laid down in Article 19.  Article 19  1. Where the procedure laid down in this Article is to be followed, the Chairman shall, without delay, refer the matter to the Standing Veterinary Committee, either on his own initiative or at the request of the representative of a Member State.  2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the  Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.  3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.  (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit to the Council a proposal relating to the measures to be taken. The Council shall act by a  qualified majority.  If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission, save where the Council has decided against the said measures by a simple  majority.  Article 20  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994. They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member  States.  2. However, from the date laid down in paragraph 1, Member States may, subject to the general rules of the Treaty, maintain or apply in their territory stricter provisions than those laid down by this Directive. They shall notify the Commission of any  such measure.  3. Member States shall communicate to the Commission the main provisions of national law which they adopt in the field covered by this Directive.  Article 21  This Directive is addressed to the Member States.  Done at Luxembourg, 24 June 1993.  For the Council The President B. WESTH (1) OJ No C 172, 8. 7. 1992, p. 16.(2) OJ No C 150, 31. 5. 1993.(3) OJ No C 19, 25. 1. 1993, p. 4.(4) OJ No L 46, 19. 2. 1991, p. 1.(5) OJ No L 224, 18. 8. 1990, p. 19. Decision as last amended by Decision 92/438/EEC (OJ No L 243, 25. 8. 1992,  p. 27).(6) Council Directive 90/667/EEC of 27 November 1990 laying down the veterinary rules for the disposal and processing of animal waste, for its placing on the market and for the prevention of pathogens in feedstuffs of animal or fish origin and  amending Directive 90/425/EEC (OJ No L 363, 27. 12. 1990, p. 51). Directive as amended by Directive 92/118/EEC (OJ No L 62, 15. 3. 1992, p. 49).   ANNEX A   NATIONAL REFERENCE LABORATORIES FOR FISH DISEASES  Belgium: Institut National de Recherches Vétérinaires Groeselenberg, 99 1180 Bruxelles.  Denmark: Statens Veterinaere Serumlaboratorium Landbrugsministeriet Hangoevej 2 8200 Aarhus N.  Germany: Bundesforschungsanstalt fuer Viruskrankheiten der Tiere Anstaltsteil Insel Riems O-2201 Insel Riems.  Greece: Ergastirio Ichthyopathologias kai Viopathologias Ydrovion Organismon Kentro Ktiniatrikon Idrymaton Athinon Institoyto Loimodon kai Parastikon Nosimaton Neapoleos 25, Agia Paraskevi Attikis 153 10 Athina Spain: Laboratorio de Sanidad y Produccíon Animal de Algete Madrid.  France: Centre National d'Etudes Vétérinaires et Alimentaires Laboratoire Central de Recherches Vétérinaires 22, rue Pierre Curier BP 67 94703 Maisons-Alfort CEDEX.  Ireland: Fisheries Research Centre Abbotstown Castleknock Dublin 15.  Italy: Istituto Zooprofilattico Sperimentale delle Venezie Sezione Diagnostica di Basaldella di Campoformido Laboratorio di Ittiopatologia Via della Roggia 92 33030 Basaldella di Campoformido (Udine).  Luxembourg: Institut de Recherches Vétérinaires Groeselenberg, 99 1180 Bruxelles.  Netherlands: Centraal Diergeneeskundig Instituut Hoofdgebouw Edelhertweg 15 8219 PH Lelystad Postbus 65 8200 AB Lelystad.  Centraal Diergeneeskundig Instituut Vestiging Virologie Houtribweg 39 8221 RA Lelystad Postbus 365 8200 AJ Lelystad.  Portugal: Laboratório Nacional de Investigaçao Veterinária Estrada de Benefica 701 1500 Lisboa.  United Kingdom: Fish Disease Laboratory 14 Albany Road Granby Industrial Site Weymouth Dorset DT4 9TU.  The Marine Laboratory PO Box 101 Victoria Road Aberdeen AB9 8DB.   ANNEX B   COMMUNITY REFERENCE LABORATORY FOR FISH DISEASES  Statens Veterinaere Serumlaboratorium Landbrugsministeriet Hangoevej 2 8200 Aarhus N Denmark.   ANNEX C   FUNCTIONS AND DUTIES OF THE COMMUNITY REFERENCE LABORATORY FOR FISH DISEASES  The functions and duties of the Community reference laboratory for list I and II diseases shall be:  1. to coordinate, in consultation with the Commission, the methods employed in the Member States for diagnosing the disease concerned, specifically by:  (a) typing, storing and supplying strains of the pathogen of the relevant disease for serological tests and the preparation of antisera;  (b) supplying standard sera and other reference reagents to the national reference laboratories in order to standardize the tests and reagents used in each Member State;  (c) building up and retaining a collection of strains and isolates of the relevant pathogen;  (d) organizing periodic comparative tests of diagnostic procedures at Community level;  (e) collecting and collating data and information on the methods of diagnosis used and the results of tests carried out in the Community;  (f) characterizing isolates of the pathogen of the relevant disease by the most up-to-date and appropriate methods to allow greater understanding of the epizootiology of the disease;  (g) keeping abreast of developments in the surveillance, epizootiology and prevention of the relevant disease throughout the world;  (h) retaining expertise on the relevant disease pathogen and other pertinent pathogens to enable rapid differential diagnosis;  (i) acquiring a thorough knowledge of the preparation and use of the products of veterinary immunology used to eradicate and control the relevant disease;  2. to assist actively in the diagnosis of outbreaks of the relevant disease in Member States by receiving pathogen isolates for confirmatory diagnosis, characterization and epizootic studies;  3. to facilitate the training or retraining of experts in laboratoy diagnosis with a view to the harmonization of diagnostic techniques throughout the Community;  4. to collaborate as regards methods of diagnosing list I diseases, with the competent laboratories in third countries where those diseases are prevalent.   ANNEX D   MINIMUM CRITERIA FOR CONTINGENCY PLANS  Contingency plans shall meet at least the following criteria:  1. the establishment of a national crisis centre which shall coordinate all control measures in the Member State concerned;  2. a list shall be provided of local disease control centres with adequate facilities to coordinate the disease control measures at a local level;  3. detailed information shall be given on the staff involved in control measures, their skills and their responsibilities;  4. each local disease control centre must be able to contact rapidly persons/organizations which are directly or indirectly involved in an outbreak;  5. equipment and materials shall be available to carry out the disease control measures properly;  6. detailed instructions shall be provided on action to be taken on suspicion and confirmation of infection or contamination;  7. training programmes shall be established to maintain and develop skills in field and administrative procedures;  8. where appropriate, diagnostic laboratories must have facilities for post-mortem examination, the necessary capacity for serology, histology, etc., and must maintain the skills for rapid diagnosis (to this end, arrangements must be made for rapid  transportation of samples);  9. provisions shall be adopted to ensure the legal powers necessary for the implementation of the contingency plans.