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Document 32012D0707

    2012/707/EU: Commission Implementing Decision of 14 November 2012 establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes (notified under document C(2012) 8064) Text with EEA relevance

    OJ L 320, 17.11.2012, p. 33–50 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵This document has been published in a special edition(s) (HR)

    Legal status of the document No longer in force, Date of end of validity: 16/04/2020; Repealed by 32020D0569

    ELI: http://data.europa.eu/eli/dec_impl/2012/707/oj

    17.11.2012   

    EN

    Official Journal of the European Union

    L 320/33

    COMMISSION IMPLEMENTING DECISION

    of 14 November 2012

    establishing a common format for the submission of the information pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes

    (notified under document C(2012) 8064)

    (Text with EEA relevance)

    (2012/707/EU)

    THE EUROPEAN COMMISSION,

    Having regard to the Treaty on the Functioning of the European Union,

    Having regard to 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 (1), and in particular Article 54(4) thereof,

    Whereas:

    (1)

    Directive 2010/63/EU provides for the harmonisation of national provisions required to improve the welfare of animals used for scientific purposes and aims at the replacement, reduction and refinement of the use of animals for such purposes.

    (2)

    Article 54(1) of Directive 2010/63/EU requires Member States to send information on the implementation of that Directive to the Commission by 10 November 2018, and every 5 years thereafter.

    (3)

    Article 54(2) of Directive 2010/63/EU requires Member States to collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures. Member States are to submit that statistical information to the Commission by 10 November 2015 and every year thereafter.

    (4)

    In accordance with Article 54(3) of Directive 2010/63/EU, Member States are to submit to the Commission annually detailed information on exemptions granted under Article 6(4)(a) of that Directive.

    (5)

    A common format for submitting the information referred to in paragraphs 1, 2, and 3 of Article 54 of Directive 2010/63/EU should be established in order to ensure consistency in the implementation of that Directive.

    (6)

    In order to have comparable information on the implementation of Directive 2010/63/EU and to enable the Commission to assess the effectiveness of the implementation of that Directive at Union level, data submissions from the Member States on implementation, annual statistics on the use of animals in procedures and exemptions granted under Article 6(4)(a) should be accurate and consistent, and therefore the reporting requirements should be harmonised across Member States by establishing a common format for the submission of that information.

    (7)

    On the basis of the statistical information submitted by Member States under Article 54(2) of Directive 2010/63/EU, the Commission is required in accordance with Article 57(2) of that Directive to submit to the European Parliament and the Council a summary report on that information. In order for the data to be meaningful, accurate and comparable, it is essential to have a common format to ensure uniform reporting by all Member States.

    (8)

    To allow the list of methods for killing animals contained in Annex IV to Directive 2010/63/EU to be kept up to date with the latest scientific development, it is necessary to receive detailed information on methods granted exceptionally under Article 6(4)(a) of that Directive.

    (9)

    The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 56(3) of Directive 2010/63/EU,

    HAS ADOPTED THIS DECISION:

    Article 1

    Member States shall use the common reporting format set out in Annex I to this Decision for the submission of the information referred to in Article 54(1) of Directive 2010/63/EU.

    Article 2

    Member States shall use the common reporting format and the detailed instructions set out in Annex II to this Decision for the submission of the statistical information referred to in Article 54(2) of Directive 2010/63/EU.

    Article 3

    Member States shall use the common reporting format set out in Annex III to this Decision for the submission of the information on the exemptions granted under Article 6(4)(a) of Directive 2010/63/EU referred to in Article 54(3) of that Directive.

    Article 4

    This Decision is addressed to the Member States.

    Done at Brussels, 14 November 2012.

    For the Commission

    Janez POTOČNIK

    Member of the Commission

    (1)   OJ L 276, 20.10.2010, p. 33.

    ANNEX I

    REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU

    Details on specific events (such as numbers) are either to be collected as a snapshot covering the last year of the five-year cycle or exceptionally for the full five-year period broken down by year.

    A.   GENERAL INFORMATION

    Changes made to national measures regarding the implementation of Directive 2010/63/EU since the previous report.

    B.   STRUCTURES AND FRAMEWORK

    1.   Competent authorities (Article 59 of Directive 2010/63/EU)

    information on the framework for competent authorities, including the numbers and types of authorities.

    2.   National committee (Article 49 of Directive 2010/63/EU)

    information on the structure and operation of the national committee.

    3.   Education and training of personnel (Article 23 of Directive 2010/63/EU)

    information on the minimum requirements referred to in Article 23(3) of Directive 2010/63/EU including any additional educational and training requirements for staff coming from another Member State.

    4.   Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU)

    description of the processes of project evaluation and authorisation and how the requirements of Articles 38 and 40 of Directive 2010/63/EU are met.

    C.   OPERATION

    1.   Projects

    i.

    granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)

     

    information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";

     

    information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

    ii.

    retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of Directive 2010/63/EU)

     

    information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);

     

    information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

    2.   Animals bred for use in procedures (Articles 10, 28 and 30 of Directive 2010/63/EU)

    i.

    animals bred, killed and not used in procedures including genetically altered animals not covered in the annual statistics, covering the calendar year prior to that in which the 5-year report is submitted; the global figure shall differentiate those animals involved in GA creation and maintenance of established GA-lines (including wild-type offspring);

    ii.

    the sourcing of non-human primates and how the requirements of Articles 10 and 28 of Directive 2010/63/EU are met.

    3.   Exemptions

    information on circumstances under which exemptions were granted in accordance with Articles 10(3), 12(1), 33(3) of Directive 2010/63/EU and in particular on the exceptional circumstances referred to in Article 16(2) of that Directive where a reuse of an animal after a procedure in which the actual suffering was assessed as severe was authorised during the reporting period.

    4.   Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU)

    information on the structure and functioning of animal welfare bodies.

    D.   PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT

    1.   Principle of replacement, reduction and refinement (Articles 4 and 13 and Annex VI of Directive 2010/63/EU)

    the general measures taken to ensure that the principle of replacement, reduction and refinement is satisfactorily addressed within authorised projects as well as during housing and care also in breeding and supplying establishments.

    2.   Avoidance of duplication (Article 46 of Directive 2010/63/EU)

    general description of measures taken to ensure that there is no duplication of procedures.

    3.   Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU)

    representative information on approximate numbers, species, types of methods and their related severities of tissue sampling for the purposes of genetic characterisation carried out with and without project authorisation covering the calendar year prior to that in which the 5-year report is submitted, and on efforts made to refine those methods.

    E.   ENFORCEMENT

    1.   Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU)

    number of active authorised breeders, suppliers and users; information on suspensions or withdrawals of authorisations of breeders, suppliers and users and the reasons therefore.

    2.   Inspections (Article 34 of Directive 2010/63/EU)

    quantitative and qualitative operational information including criteria applied under Article 34(2) of Directive 2010/63/EU and proportion of unannounced inspections broken down by year.

    3.   Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)

    information and reasons for the withdrawals of project authorisation during the reporting period.

    4.   Penalties (Article 60 of Directive 2010/63/EU)

    information on the nature of infringements as well as legal and administrative actions resulting from those infringements during the reporting period.

    ANNEX II

    Image 1

    Type of animal

    Mice (Mus musculus)

    Rats (Rattus norvegicus)

    Guinea-Pigs (Cavia porcellus)

    Hamsters (Syrian) (Mesocricetus auratus)

    Hamsters (chinese) (Cricetulus griseus)

    Mongolian gerbil (Meriones unguiculatus)

    Other Rodents (other Rodentia)

    Rabbits (Oryctolagus cuniculus)

    Cats (Felis catus)

    Dogs (Canis familiaris)

    Ferrets (Mustela putorius furo)

    Other carnivores (other Carnivora)

    Horses, donkeys & cross-breeds (Equidae)

    Pigs (Sus scrofa domesticus)

    Goats (Capra aegagrus hircus)

    Sheep (Ovis aries)

    Cattle (Bos primigenius)

    Prosimians (Prosimia)

    Marmoset and tamarins (eg. Callithrix jacchus)

    Cynomolgus monkey (Macaca fascicularis)

    Rhesus monkey (Macaca mulatta)

    Vervets Chlorocebus spp. (usually either pygerythrus or sabaeus)

    Baboons (Papio spp.)

    Squirrel monkey (eg. Saimiri sciureus)

    Other species of non-human primates (other species of Ceboidea and Cercopithecoidea)

    Apes (Hominoidea)

    Other Mammals (other Mammalia)

    Domestic fowl (Gallus gallus domesticus)

    Other birds (other Aves)

    Reptiles (Reptilia)

    Rana (Rana temporaria and Rana pipiens)

    Xenopus (Xenopus laevis and Xenopus tropicalis)

    Other Amphibians (other Amphibia)

    Zebra fish (Danio rerio)

    Other Fish (other Pisces)

    Cephalopods (Cephalopoda)

    Basic research studies

    Oncology

    Cardiovascular Blood and Lymphatic System

    Nervous System

    Respiratory System

    Gastrointestinal System including Liver

    Musculoskeletal System

    Immune System

    Urogenital/Reproductive System

    Sensory Organs (skin, eyes and ears)

    Endocrine System/Metabolism

    Multisystemic

    Ethology / Animal Behaviour /Animal Biology

    Other

    END

    Translational and applied research

    Human Cancer

    Human Infectious Disorders

    Human Cardiovascular Disorders

    Human Nervous and Mental Disorders

    Human Respiratory Disorders

    Human Gastrointestinal Disorders including Liver

    Human Musculoskeletal Disorders

    Human Immune Disorders

    Human Urogenital/Reproductive Disorders

    Human Sensory Organ Disorders (skin, eyes and ears)

    Human Endocrine/Metabolism Disorders

    Other Human Disorders

    Animal Diseases and Disorders

    Animal Welfare

    Diagnosis of diseases

    Plant diseases

    Non-regulatory toxicology and ecotoxicology

    END

    Ecotoxicity

    Acute toxicity

    Chronic toxicity

    Reproductive toxicity

    Endocrine activity

    Bioaccumulation

    Other

    END