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Commission Implementing Decision (EU) 2020/569Show full title

Commission Implementing Decision (EU) 2020/569 of 16 April 2020 establishing a common format and information content for the submission of the information to be reported by Member States pursuant to Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes and repealing Commission Implementing Decision 2012/707/EU (notified under document C(2020) 2179) (Text with EEA relevance)

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  1. Introductory Text

  2. Article 1.For the purposes of the second sentence of Article 43(3)...

  3. Article 2.For the purposes of Article 54(1) of Directive 2010/63/EU, Member...

  4. Article 3.For the purposes of Article 54(2) of Directive 2010/63/EU, Member...

  5. Article 4.For the purposes of Article 54(3) of Directive 2010/63/EU, Member...

  6. Article 5.Implementing Decision 2012/707/EU is repealed with effect from 17 April...

  7. Article 6.This Decision is addressed to the Member States.

  8. Signature

    1. ANNEX I

      1. PART A Template for the submission of non-technical project summaries referred to in article 43(1) of directive 2010/63/EU

      2. PART B Template for the submission of an update to the non-technical project summary referred to in article 43(2) of directive 2010/63/EU

    2. ANNEX II

      INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU

      1. A. NATIONAL MEASURES ON THE IMPLEMENTATION OF DIRECTIVE 2010/63/EU

      2. B. STRUCTURES AND FRAMEWORK

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

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

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

        4. 4. Project evaluation and authorisation (Articles 38 and 40 of Directive...

      3. C. OPERATION

        1. 1. Projects

          1. 1.1. Granting of project authorisation (Articles 40 and 41 of Directive...

            1. 1.1.1. In respect of each year, provide numbers for the following:...

            2. 1.1.2. For the purposes of point (c), provide summary information, covering...

          2. 1.2. Retrospective assessment, non-technical project summaries (Article 38(2)(f), Articles 39 and...

            1. 1.2.1. Explain the measures taken to ensure compliance with the requirements...

            2. 1.2.2. In respect of each year, provide the number of projects...

            3. 1.2.3. Provide summary information, covering the five-year reporting cycle, on the...

        2. 2. Animals bred for use in procedures (Articles 10, 28 and...

          1. 2.1. Provide the species and numbers of animals that were bred...

          2. 2.1.1. Include animals killed for organs or tissues and animals from...

          3. 2.1.2. Categorise these animals as one of the following types:

          4. 2.1.3. The category referred to in point (a) excludes animals as...

          5. 2.1.4. The categories referred to in points (b) and (c) include...

          6. 2.1.5. The categories referred to in points 2.1.2(d) and (e) exclude...

          7. 2.2. Explain the measures taken to ensure compliance with the requirements...

        3. 3. Exemptions

          1. 3.1. Provide summary information, covering the five-year reporting cycle, on circumstances...

          2. 3.2. Provide information for the same period on any exceptional circumstances...

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

      4. D. PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT

        1. 1. Principle of replacement, reduction and refinement (Articles 4 and 13...

          1. 1.1. Provide information on the measures taken to ensure that the...

          2. 1.2. Provide information on the measures taken to ensure that the...

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

        3. 3. Tissue sampling of genetically altered animals (Articles 4, 30 and...

          1. 3.1. In respect of tissue sampling for the purposes of genetic...

          2. 3.2. List the criteria used to ensure that the information in...

          3. 3.3. Provide information on efforts made to refine tissue sampling methods....

      5. E. ENFORCEMENT

        1. 1. Authorisation of breeders, suppliers and users (Articles 20 and 21...

          1. 1.1. In respect of each year, provide numbers for all active...

          2. 1.2. Provide summary information, covering the five-year reporting cycle, on reasons...

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

          1. 2.1. In respect of each year, provide numbers for inspections, broken...

          2. 2.2. Provide summary information, covering the five-year reporting cycle, on main...

          3. 2.3. Explain the measures taken to ensure compliance with the requirements...

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

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

          1. 4.1. Provide summary information, covering the five-year reporting cycle, on the...

    3. ANNEX III

      1. PART A Flowchart of statistical data input categories under article 54(2) of directive 2010/63/EU

      2. PART B Information referred to in article 54(2) of directive 2010/63/EU

        1. A. GENERAL PROVISIONS

          1. 1. The data shall be reported on each use of an...

          2. 2. When reporting data for an animal, only one option within...

          3. 3. Animals killed for organs and tissues

          4. 4. Animals that are bred and killed without being used in...

          5. 5. Genetically normal animals born during the creation of a new...

          6. 6. Larval forms of animals shall be included once they become...

          7. 7. Foetal and embryonic forms of mammalian species shall be excluded...

          8. 8. Where the use of an animal in a procedure results...

          9. 9. Data relating to animals used in a procedure shall be...

          10. 10. Where the ‘Other’ categories are used, an entry shall be...

          11. 11. Genetically altered animals

        2. B. DATA INPUT CATEGORIES

          1. 1. Type of animal

            1. 1.1. Fish shall be reported from the stage of independent feeding...

            2. 1.2. The time at which fish feed independently is different for...

            3. 1.3. Due to the small size of some fish and cephalopod...

            4. 1.4. All cephalopod species shall be reported under the heading ‘cephalopod’...

          2. 2. Reuse

            1. 2.1. General

            2. 2.2. Reuse versus continued use

          3. 3. Species other than non-human primate – Place of birth

            1. 3.1. Origin is based on the place of birth, that is...

            2. 3.2. ‘Animals born at an authorised breeder in the Union’ refers...

            3. 3.3. ‘Animals born in the Union’ but not at an authorised...

            4. 3.4. ‘Animals born in the rest of Europe’ includes, amongst others,...

            5. 3.5. ‘Animals born elsewhere’ groups together all animals, irrespective of whether...

          4. 4. Non-human primate (NHP) – Place of birth

            1. 4.1. Origin is based on the place of birth, that is...

            2. 4.2. ‘NHP born at an authorised breeder in the Union’ (and...

            3. 4.3. ‘NHP born in the Union but not at an authorised...

            4. 4.4. ‘NHP born in Asia’ includes, amongst others animals born in...

            5. 4.5. ‘NHP born in America’ refers to animals born in the...

            6. 4.6. ‘NHP born in Africa’ includes also animals born in Mauritius....

            7. 4.7. ‘NHP born elsewhere’ includes also animals born in Australasia. The...

          5. 5. Non-human primate – Colony type

          6. 6. Non-human primate – Generation

            1. 6.1. ‘F0’ refers to animals that are captured from the wild....

            2. 6.2. ‘F1’ refers to animals that are born in captivity to...

            3. 6.3. ‘F2 or greater’ refers to animals that are born in...

          7. 7. Genetic status

            1. 7.1. ‘Not genetically altered’ refers to all animals that have not...

            2. 7.2. ‘Genetically altered without a harmful phenotype’ refers to

            3. 7.3. ‘Genetically altered with a harmful phenotype’ refers to

          8. 8. Creation of a new genetically altered line

          9. 9. Severity

            1. 9.1. Actual severity shall be reported for each animal individually by...

            2. 9.2. Severity categories

            3. 9.3. Animals found dead

            4. 9.4. Capture and transport of animals taken from the wild

          10. 10. Purposes

            1. 10.1. Basic research

            2. 10.2. Translational and applied research

            3. 10.3. Regulatory use and Routine production

            4. 10.4. Protection of the natural environment in the interests of the...

            5. 10.5. Higher education

            6. 10.6. Training for the acquisition, maintenance or improvement of vocational skills...

            7. 10.7. Maintenance of colonies of established genetically altered animals, not used...

          11. 11. Basic research studies

            1. 11.1. Oncology

            2. 11.2. Nervous system

            3. 11.3. Musculoskeletal System

            4. 11.4. Sensory Organs (skin, eyes and ears)

            5. 11.5. Developmental Biology covers studies of changes associated with an organism...

            6. 11.6. Multisystemic

            7. 11.7. ‘Ethology/Animal Behaviour/Animal Biology’ category covers both animals in the wild...

            8. 11.8. Other Basic Research

            9. 11.9. Remarks

            10. 12. Translational and applied research

            11. 12.1. Any applied research on human cancer shall be included in...

            12. 12.2. Any applied research on human infectious disorders shall be included...

            13. 12.3. Any regulatory use of animals, such as regulatory carcinogenicity studies,...

            14. 12.4. Studies on disorders of the nose shall be reported under...

            15. 12.5. Particular attention shall be paid before using category ‘Other Human...

            16. 12.6. ‘Diagnosis of Diseases’ includes, amongst others, animals used in direct...

            17. 12.7. ‘Non-regulatory Toxicology and Ecotoxicology’ refers to discovery toxicology and investigations...

            18. 12.8. ‘Animal welfare’ refers to studies as per Article 5(b)(iii) of...

            19. 12.9. Remarks

          12. 13. Regulatory use and Routine production

            1. 13.1. Efficacy testing during the development of new medicinal product is...

            2. 13.2. Quality control refers to animals used in the testing of...

            3. 13.3. Other efficacy and tolerance testing

            4. 13.4. Toxicity and other safety testing (including safety evaluation of products...

            5. 13.5. Routine production by product type

          13. 14. Quality control (including batch safety and potency testing)

          14. 15. Toxicity and other safety testing by test type

            1. 15.1. ‘Repeated dose toxicity’ includes also immunotoxicological studies.

            2. 15.2. ‘Reproductive toxicity’ includes, amongst others, extended one-generation reproductive toxicity studies,...

            3. 15.3. ‘Developmental toxicity’ includes also developmental neurotoxicity studies. Extended one-generation reproductive...

            4. 15.4. ‘Neurotoxicity’ includes, amongst others, acute delayed effects (for example, delayed...

            5. 15.5. ‘Kinetics’ refers to pharmacokinetics, toxicokinetics and residue depletion. However, if...

            6. 15.6. ‘Safety testing in the food and feed area’ includes also...

            7. 15.7. ‘Target animal safety’ testing ensures that a product for a...

            8. 15.8. ‘Combined end-points’ include, amongst others, combination of carcinogenicity and chronic...

          15. 16. Acute toxicity testing methods

            1. 16.1. The sub-category shall be reported on the basis of the...

            2. 16.2. ‘LD50, LC50’ refer only to test methods that provide a...

            3. 16.3. ‘Other lethal methods’ refers to those methods that categorise substances...

          16. 17. Repeated dose toxicity

          17. 18. Ecotoxicity

            1. 18.1. Ecotoxicity refers to toxicity relating to the aquatic and terrestrial...

            2. 18.2. Ecotoxicity studies addressing short-term toxicity to determine LC/LD50 shall be...

            3. 18.3. Ecotoxicity studies addressing long-term toxicity, for example, early life cycle...

            4. 18.4. Ecotoxicity studies carried out to primarily assess endocrine properties of...

          18. 19. Type of legislation

            1. 19.1. The type of legislation shall not be reported for animals...

            2. 19.2. The type of legislation shall be reported by reference to...

            3. 19.3. Testing of the quality of water, other than waste water,...

          19. 20. Origin of legislation

            1. 20.1. The origin of legislation shall not be reported for animals...

            2. 20.2. The use shall be reported in reference to the region...

            3. 20.3. Where national legislation is derived from Union legislation, the use...

            4. 20.4. ‘Legislation satisfying Union requirements’ also includes any international requirement, which...

            5. 20.5. Where the test is carried out to satisfy the legislation...

            6. 20.6. Legislation satisfying Non-Union requirements is to be chosen only where...

          20. 21. Routine production by product type

            1. 21.1. Routine production by product type covers the production of antibodies...

            2. 21.2. All use of the ascites method for the culture of...

            3. 21.3. The use of animals for antibody production for commercial purposes,...

        3. C. MEMBER STATE NARRATIVE

          1. 1. Member States shall provide a narrative on the statistical data....

          2. 2. For the purposes of point 1(g), the following shall be...

    4. ANNEX IV

      TEMPLATE FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(3) OF DIRECTIVE 2010/63/EU

    5. ANNEX V

      CORRELATION TABLE

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