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Directive 2010/63/EU of the European Parliament and of the CouncilShow full title

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (Text with EEA relevance)

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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.

  1. Introductory Text

  2. CHAPTER I GENERAL PROVISIONS

    1. Article 1.Subject matter and scope

    2. Article 2.Stricter national measures

    3. Article 3.Definitions

    4. Article 4.Principle of replacement, reduction and refinement

    5. Article 5.Purposes of procedures

    6. Article 6.Methods of killing

  3. CHAPTER II PROVISIONS ON THE USE OF CERTAIN ANIMALS IN PROCEDURES

    1. Article 7.Endangered species

    2. Article 8.Non-human primates

    3. Article 9.Animals taken from the wild

    4. Article 10.Animals bred for use in procedures

    5. Article 11.Stray and feral animals of domestic species

  4. CHAPTER III PROCEDURES

    1. Article 12.Procedures

    2. Article 13.Choice of methods

    3. Article 14.Anaesthesia

    4. Article 15.Classification of severity of procedures

    5. Article 16.Reuse

    6. Article 17.End of the procedure

    7. Article 18.Sharing organs and tissues

    8. Article 19.Setting free of animals and rehoming

  5. CHAPTER IV AUTHORISATION

    1. Section 1 Requirements for breeders, suppliers and users

      1. Article 20.Authorisation of breeders, suppliers and users

      2. Article 21.Suspension and withdrawal of authorisation

      3. Article 22.Requirements for installations and equipment

      4. Article 23.Competence of personnel

      5. Article 24.Specific requirements for personnel

      6. Article 25.Designated veterinarian

      7. Article 26.Animal-welfare body

      8. Article 27.Tasks of the animal-welfare body

      9. Article 28.Breeding strategy for non-human primates

      10. Article 29.Scheme for rehoming or setting free of animals

      11. Article 30.Animal records

      12. Article 31.Information on dogs, cats and non-human primates

      13. Article 32.Marking and identification of dogs, cats and non-human primates

      14. Article 33.Care and accommodation

    2. Section 2 Inspections

      1. Article 34.Inspections by the Member States

      2. Article 35.Controls of Member State inspections

    3. Section 3 Requirements for projects

      1. Article 36.Project authorisation

      2. Article 37.Application for project authorisation

      3. Article 38.Project evaluation

      4. Article 39.Retrospective assessment

      5. Article 40.Granting of project authorisation

      6. Article 41.Authorisation decisions

      7. Article 42.Simplified administrative procedure

      8. Article 43.Non-technical project summaries

      9. Article 44.Amendment, renewal and withdrawal of a project authorisation

      10. Article 45.Documentation

  6. CHAPTER V AVOIDANCE OF DUPLICATION AND ALTERNATIVE APPROACHES

    1. Article 46.Avoidance of duplication of procedures

    2. Article 47.Alternative approaches

    3. Article 48.Union Reference Laboratory

    4. Article 49.National committees for the protection of animals used for scientific purposes

  7. CHAPTER VI FINAL PROVISIONS

    1. Article 50.Adaptation of Annexes to technical progress

    2. Article 51.Exercise of the delegation

    3. Article 52.Revocation of the delegation

    4. Article 53.Objections to delegated acts

    5. Article 54. Information on implementation and provision of statistical data

    6. Article 55.Safeguard clauses

    7. Article 56.Committee

    8. Article 57. Commission report

    9. Article 58.Review

    10. Article 59.Competent authorities

    11. Article 60.Penalties

    12. Article 61.Transposition

    13. Article 62.Repeal

    14. Article 63.Amendment of Regulation (EC) No 1069/2009

    15. Article 64.Transitional provisions

    16. Article 65.Entry into force

    17. Article 66.Addressees

    1. ANNEX I

      LIST OF ANIMALS REFERRED TO IN ARTICLE 10

      1. Mouse (Mus musculus) Rat (Rattus norvegicus) Guinea pig (Cavia porcellus)...

    2. ANNEX II

    3. ANNEX III

      REQUIREMENTS FOR ESTABLISHMENTS AND FOR THE CARE AND ACCOMMODATION OF ANIMALS

      1. Section A: General section

        1. 1. The physical facilities

          1. 1.1. Functions and general design

            1. (a) All facilities shall be constructed so as to provide an...

            2. (b) Establishments shall have an active maintenance programme to prevent and...

          2. 1.2. Holding rooms

            1. (a) Establishments shall have a regular and efficient cleaning schedule for...

            2. (b) Walls and floors shall be surfaced with a material resistant...

            3. (c) Species that are incompatible, for example predator and prey, or...

          3. 1.3. General and special purpose procedure rooms

            1. (a) Establishments shall, where appropriate, have available laboratory facilities for the...

            2. (b) Facilities shall be provided to enable newly-acquired animals to be...

            3. (c) There shall be accommodation for the separate housing of sick...

          4. 1.4. Service rooms

            1. (a) Store-rooms shall be designed, used and maintained to safeguard the...

            2. (b) The cleaning and washing areas shall be large enough to...

            3. (c) Establishments shall provide for the hygienic storage and safe disposal...

            4. (d) Where surgical procedures under aseptic conditions are required there shall...

        2. 2. The environment and control thereof

          1. 2.1. Ventilation and temperature

            1. (a) Insulation, heating and ventilation of the holding room shall ensure...

            2. (b) Temperature and relative humidity in the holding rooms shall be...

            3. (c) Animals shall not be restricted to outdoor areas under climatic...

          2. 2.2. Lighting

            1. (a) Where natural light does not provide an appropriate light/dark cycle,...

            2. (b) Illumination shall satisfy the needs for the performance of husbandry...

            3. (c) Regular photoperiods and intensity of light adapted to the species...

            4. (d) When keeping albino animals, the lighting shall be adjusted to...

          3. 2.3. Noise

            1. (a) Noise levels including ultrasound, shall not adversely affect animal welfare....

            2. (b) Establishments shall have alarm systems that sound outside the sensitive...

            3. (c) Holding rooms shall where appropriate be provided with noise insulation...

          4. 2.4. Alarm systems

            1. (a) Establishments relying on electrical or mechanical equipment for environmental control...

            2. (b) Heating and ventilation systems shall be equipped with monitoring devices...

            3. (c) Clear instructions on emergency procedures shall be prominently displayed.

        3. 3. Care of animals

          1. 3.1. Health

            1. (a) Establishments shall have a strategy in place to ensure that...

            2. (b) Animals shall be checked at least daily by a competent...

          2. 3.2. Animals taken from the wild

            1. (a) Transport containers and means of transport adapted to the species...

            2. (b) Special consideration shall be given and appropriate measures taken for...

          3. 3.3. Housing and enrichment

            1. (a) Housing

            2. (b) Enrichment

            3. (c) Animal enclosures

          4. 3.4. Feeding

            1. (a) The form, content and presentation of the diet shall meet...

            2. (b) The animals’ diet shall be palatable and non-contaminated. In the...

            3. (c) Packing, transport and storage shall be such as to avoid...

            4. (d) Each animal shall be able to access the food, with...

          5. 3.5. Watering

            1. (a) Uncontaminated drinking water shall always be available to all animals....

            2. (b) When automatic watering systems are used, they shall be regularly...

            3. (c) Provision shall be made to adapt the water supply for...

          6. 3.6. Resting and sleeping areas

            1. (a) Bedding materials or sleeping structures adapted to the species shall...

            2. (b) Within the animal enclosure, as appropriate to the species, a...

          7. 3.7. Handling

      2. Section B: Species-specific section

        1. 1. Mice, rats, gerbils, hamsters and guinea pigs

          1. Table 1.1. Mice

          2. Table 1.2. Rats

          3. Table 1.3. Gerbils

          4. Table 1.4. Hamsters

          5. Table 1.5. Guinea pigs

        2. 2. Rabbits

          1. Table 2.1. Rabbits over 10 weeks of age

          2. Table 2.2. Doe plus litter

          3. Table 2.3. Rabbits less than 10 weeks of age

          4. Table 2.4. Rabbits: Optimal dimensions for raised areas for enclosures having the...

        3. 3. Cats

          1. Table 3. Cats

        4. 4. Dogs

          1. Table 4.1. Dogs

          2. Table 4.2. Dogs — post-weaned stock

        5. 5. Ferrets

          1. Table 5. Ferrets

        6. 6. Non-human primates

          1. Table 6.1. Marmosets and tamarins

          2. Table 6.2. Squirrel monkeys

        7. 7. Farm animals

          1. Table 7.1. Cattle

          2. Table 7.2. Sheep and goats

          3. Table 7.3. Pigs and minipigs

          4. Table 7.4. Equines

        8. 8. Birds

          1. Table 8.1. Domestic fowl

          2. Table 8.2. Domestic turkeys

          3. Table 8.3. Quails

          4. Table 8.4. Ducks and geese

          5. Table 8.6. Pigeons

          6. Table 8.7. Zebra finches

        9. 9. Amphibians

          1. Table 9.1. Aquatic urodeles

          2. Table 9.3. Semi-aquatic anurans

          3. Table 9.4. Semi-terrestrial anurans

          4. Table 9.5. Arboreal anurans

        10. 10. Reptiles

          1. Table 10.1. Aquatic chelonians

          2. Table 10.2. Terrestrial snakes

        11. 11. Fish

          1. 11.1. Water supply and quality

          2. 11.2. Oxygen, nitrogen compounds, pH, and salinity

          3. 11.3. Temperature, lighting, noise

          4. 11.4. Stocking density and environmental complexity

          5. 11.5. Feeding and handling

    4. ANNEX IV

      METHODS OF KILLING ANIMALS

      1. 1. In the process of killing animals, methods listed in the...

      2. 2. The killing of animals shall be completed by one of...

      3. 3. Table

        1. Requirements

          1. 1. Shall, where appropriate, be used with prior sedation.

          2. 2. Only to be used on large reptiles.

          3. 3. Only to be used in gradual fill. Not to be...

          4. 4. Only to be used for birds under 1 kg. Birds over...

          5. 5. Only to be used for rodents under 1 kg. Rodents over...

          6. 6. Only to be used for rabbits under 1 kg. Rabbits over...

          7. 7. Only to be used for birds under 5 kg.

          8. 8. Only to be used for rodents under 1 kg.

          9. 9. Only to be used for rabbits under 5 kg.

          10. 10. Only to be used on neonates.

          11. 11. Only to be used for birds under 250 g.

          12. 12. Only to be used if other methods are not possible....

          13. 13. Specialised equipment required.

          14. 14. Only to be used on pigs.

          15. 15. Only to be used in field conditions by experienced marksmen....

          16. 16. Only to be used in field conditions by experienced marksmen...

    5. ANNEX V

      LIST OF ELEMENTS REFERRED TO IN ARTICLE 23(3)

      1. National legislation in force relevant to the acquisition, husbandry, care...

    6. ANNEX VI

      LIST OF ELEMENTS REFERRED TO IN ARTICLE 37(1)(c)

      1. Relevance and justification of the following: use of animals including...

    7. ANNEX VII

      DUTIES AND TASKS OF THE UNION REFERENCE LABORATORY

      1. 1. The Union Reference Laboratory referred to in Article 48 is...

      2. 2. The Union Reference Laboratory shall be responsible, in particular, for:...

      3. 3. The Union Reference Laboratory shall participate in the validation of...

    8. ANNEX VIII

      SEVERITY CLASSIFICATION OF PROCEDURES

      1. The severity of a procedure shall be determined by the...

      2. Section I: Severity categories

        1. Non-recovery:

        2. Mild:

        3. Moderate:

        4. Severe:

      3. Section II: Assignment criteria

      4. Section III: Examples of different types of procedure assigned to each of...

        1. 1. Mild:

        2. 2. Moderate:

        3. 3. Severe:

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