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)
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
ANNEX I
PART A
Template for the submission of non-technical project summaries referred to in article 43(1) of directive 2010/63/EU
Title of the project |
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Duration of project (in months) |
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Key Words (maximum of 5)(1) |
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Purpose of project (2) (multiple choices possible) |
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Objectives and predicted benefits of the project |
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Describe the objectives of the project (for example, addressing certain scientific unknowns, or scientific or clinical needs). |
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What are the potential benefits likely to derive from this project? Explain how science could be advanced, or humans, animals or environment may ultimately benefit from the project. Where applicable, differentiate between short-term benefits (within the duration of the project) and long-term benefits (which may accrue after the project is finished). |
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Predicted harms |
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In what procedures will the animals typically be used (for example, injections, surgical procedures)? Indicate the number and duration of these procedures. |
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What are the expected impacts/adverse effects on the animals, for example pain, weight loss, inactivity/reduced mobility, stress, abnormal behaviour, and the duration of those effects? |
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What species and numbers of animals are expected to be used? What are the expected severities and the numbers of animals in each severity category (per species)? |
Species (4) |
Estimated total numbers |
Estimated numbers per severity |
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Non-recovery |
Mild |
Moderate |
Severe |
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What will happen to the animals kept alive at the end of the procedure?(5) , (6) |
Estimated number to be reused |
Estimated number to be returned to habitat/husbandry system |
Estimated number to be rehomed |
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Please provide reasons for the planned fate of the animals after the procedure. |
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Application of the Three Rs |
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1. Replacement State which non-animal alternatives are available in this field and why they cannot be used for the purposes of the project. |
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2. Reduction Explain how the numbers of animals for this project were determined. Describe steps that have been taken to reduce the number of animals to be used, and principles used to design studies. Where applicable, describe practices that will be used throughout the project to minimise the number of animals used consistent with scientific objectives. Those practices may include e.g. pilot studies, computer modelling, sharing of tissue and reuse. |
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3. Refinement Give examples of the specific measures (e.g., increased monitoring, post-operative care, pain management, training of animals) to be taken, in relation to the procedures, to minimise welfare costs (harms) to the animals. Describe the mechanisms to take up emerging refinement techniques during the lifetime of the project. |
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Explain the choice of species and the related life stages. |
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Project selected for Retrospective Assessment (7) |
Deadline |
Contains severe procedures |
Uses non-human primates |
Other reason |
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
Title (as per Non-technical Project Summary) |
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Reason for Retrospective Assessment (8) |
Using non-human primates |
Contains ‘severe’procedures |
Other reason |
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Explain ‘Other reason’ |
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Achievement of objectives |
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Explain briefly whether, and to what extent, the objectives set out in the authorised project have been achieved. Provide reasons if objectives have not been attained. Have there been any other significant findings? What benefits have resulted from the work to date, and are further benefits expected? Have the results of this project been disseminated, including where hypotheses are not proven? If so, describe how. If not, indicate how and when results are expected to be publicised. |
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Harms |
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Species (9) |
Total numbers of animals used |
Numbers of animals per actual severity |
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Non-recovery |
Mild |
Moderate |
Severe |
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How do numbers of animals used and actual severities compare with those estimated? Where the actual numbers are higher than the estimated numbers, please provide an explanation. Where the actual numbers are lower, please provide an explanation unless that difference is a result of Reduction or Refinement? |
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How does the fate of animals kept alive at the end of the study compare with the estimated fate? Please provide an explanation. |
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Any elements that may contribute to further implementation of the Three Rs: |
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1. Replacement |
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With the knowledge obtained from this project, have any new approaches that could replace some or all of the use of animals in similar projects been identified/developed (including the development/validation of new in vitro or in silico techniques)? |
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2. Reduction |
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With the knowledge obtained from this project, could the experimental design be improved to enable any further reduction of the use of animals, and if so, how? Provide an explanation where numbers of animals used were lower than those originally estimated. |
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3. Refinement |
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Provide an explanation where the actual severities were lower than those originally estimated. With the new knowledge obtained from this project, are the animal models used still the most appropriate? Please specify per species/model, where appropriate. List any novel refinements introduced during the project to reduce harm to the animals or to improve their welfare. What are the potential opportunities for further refinement in the future, for example, emerging technologies, techniques, improved welfare assessment methods, earlier endpoints, housing/husbandry measures? |
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4. Other |
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How are the findings for further implementation of the Three Rs disseminated? |
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Additional comments |
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ANNEX II
INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EU
A. NATIONAL MEASURES ON THE IMPLEMENTATION OF DIRECTIVE 2010/63/EU
B. STRUCTURES AND FRAMEWORK
1.
Competent authorities (Article 59 of Directive 2010/63/EU)
2.
National committee (Article 49 of Directive 2010/63/EU)
3.
Education and training of personnel (Article 23 of Directive 2010/63/EU)
4.
Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU)
C. OPERATION
1.
Projects
1.1.
Granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)
1.2.
Retrospective assessment, non-technical project summaries (Article 38(2)(f), Articles 39 and 43 of Directive 2010/63/EU)
2.
Animals bred for use in procedures (Articles 10, 28 and 30 of Directive 2010/63/EU)
3.
Exemptions
4.
Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU)
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)
2.
Avoidance of duplication (Article 46 of Directive 2010/63/EU)
3.
Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU)
E. ENFORCEMENT
1.
Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU)
2.
Inspections (Article 34 of Directive 2010/63/EU)
3.
Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)
4.
Penalties (Article 60 of Directive 2010/63/EU)
ANNEX III
PART A
Flowchart of statistical data input categories under article 54(2) of directive 2010/63/EU
PART B
Information referred to in article 54(2) of directive 2010/63/EU
A. GENERAL PROVISIONS
B. DATA INPUT CATEGORIES
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 and cross-breeds (Equidae) |
Pigs (Sus scrofa domesticus) |
Goats (Capra aegagrus hircus) |
Sheep (Ovis aries) |
Cattle (Bos taurus) |
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 New World monkeys (other species of Ceboidea) |
Other species of Old World monkeys (other species of Cercopithecoidea) |
Apes (Hominoidea) |
Other mammals (other Mammalia) |
Domestic fowl (Gallus gallus domesticus) |
Turkey (Meleagris gallopavo) |
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) |
Sea bass (spp. from families e.g. Serranidae, Moronidae) |
Salmon, trout, chars and graylings (Salmonidae) |
Guppy, swordtail, molly, platy (Poeciliidae) |
Other fish (other Pisces) |
Cephalopods (Cephalopoda) |
2.
Reuse
Reuse (No/Yes) |
3.
Species other than non-human primate – Place of birth
Animals born at an authorised breeder in the Union |
Animals born in the Union but not at an authorised breeder |
Animals born in rest of Europe |
Animals born in elsewhere |
4.
Non-human primate (NHP) – Place of birth
NHP born at an authorised breeder in the Union |
NHP born in the Union but not at an authorised breeder, and NHP born in rest of Europe |
NHP born in Asia |
NHP born in America |
NHP born in Africa |
NHP born elsewhere |
5.
Non-human primate – Colony type
Self-sustaining colony (No/Yes) |
6.
Non-human primate – Generation
F0 |
F1 |
F2 or greater |
7.
Genetic status
Not genetically altered |
Genetically altered without a harmful phenotype |
Genetically altered with a harmful phenotype |
8.
Creation of a new genetically altered line
Animals used for the creation of a new genetically altered line/strain (No/Yes) |
9.
Severity
Non-recovery |
Mild (up to and including) |
Moderate |
Severe |
10.
Purposes
Basic research |
Translational and applied research |
Regulatory use and routine production |
Protection of the natural environment in the interests of the health or welfare of human beings or animals |
Preservation of species |
Higher education |
Training for the acquisition, maintenance or improvement of vocational skills |
Forensic enquiries |
Maintenance of colonies of established genetically altered animals, not used in other procedures |
11.
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 |
Developmental Biology |
Multisystemic |
Ethology/Animal Behaviour/Animal Biology |
Other Basic 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 Nutrition |
Animal Welfare |
Diagnosis of Diseases |
Plant Diseases |
Non-regulatory Toxicology and Ecotoxicology |
13.
Regulatory use and Routine production
Quality control (including batch safety and potency testing) |
Other efficacy and tolerance testing |
Toxicity and other safety testing including pharmacology |
Routine production by product type |
14.
Quality control (including batch safety and potency testing)
Batch safety testing |
Pyrogenicity testing |
Batch potency testing |
Other quality controls |
15.
Toxicity and other safety testing by test type
Acute (single dose) toxicity testing methods (including limit test) |
Skin irritation/corrosion |
Skin sensitisation |
Eye irritation/corrosion |
Repeated dose toxicity |
Carcinogenicity |
Genotoxicity |
Reproductive toxicity |
Developmental toxicity |
Neurotoxicity |
Kinetics (pharmacokinetics, toxicokinetics, residue depletion) |
Pharmaco-dynamics (including safety pharmacology) |
Phototoxicity |
Ecotoxicity |
Safety testing in food and feed area |
Target animal safety |
Combined end-points |
Other toxicity or safety testing |
16.
Acute toxicity testing methods
LD50, LC50 |
Other lethal methods |
Non-lethal methods |
17.
Repeated dose toxicity
28 days or less |
29 – 90 days |
more than 90 days |
18.
Ecotoxicity
Acute toxicity (ecotoxicity) |
Chronic toxicity (ecotoxicity) |
Reproductive toxicity (ecotoxicity) |
Endocrine activity (ecotoxicity) |
Bioaccumulation (ecotoxicity) |
Other ecotoxicity |
19.
Type of legislation
Legislation on medicinal products for human use |
Legislation on medicinal products for veterinary use and their residues |
Medical devices legislation |
Industrial chemicals legislation |
Plant protection product legislation |
Biocides legislation |
Food legislation including food contact material |
Feed legislation including legislation for the safety of target animals, workers and environment |
Cosmetics legislation |
Other legislation |
20.
Origin of legislation
Legislation satisfying Union requirements |
Legislation satisfying national requirements only (within Union) |
Legislation satisfying Non-Union requirements only |
21.
Routine production by product type
Blood based products |
Monoclonal antibodies by ascites method only |
Monoclonal and polyclonal antibodies (excluding ascites method) |
Other products |
C. MEMBER STATE NARRATIVE
ANNEX IV
TEMPLATE FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(3) OF DIRECTIVE 2010/63/EU
Member State: |
Year: |
Type of method |
Species |
Justification |
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ANNEX V
CORRELATION TABLE
Implementing Decision 2012/707/EU |
This Decision |
Article 1 |
Article 2 |
Article 2 |
Article 3 |
Article 3 |
Article 4 |
Article 4 |
Article 6 |
ANNEX I |
ANNEX II |
ANNEX II |
ANNEX III |
ANNEX III |
ANNEX IV |