2014/11/EU: Commission Implementing Decision of 20 December 2013 correcting Annex II to Implementing Decision 2012/707/EU 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(2013) 9220) Text with EEA relevance

• Published date: 15 January 2014
• Subject Matter: Research and technological development,Veterinary legislation
• Official Gazette Publication: Official Journal of the European Union, L 010, 15 January 2014

15.1.2014 EN Official Journal of the European Union L 10/18

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COMMISSION IMPLEMENTING DECISION

of 20 December 2013

correcting Annex II to Implementing Decision 2012/707/EU 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(2013) 9220)

(Text with EEA relevance)

(2014/11/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) Verification revealed errors in Annex II to Commission Implementing Decision 2012/707/EU (2). The flowchart included in that Annex erroneously indicated that input categories ‘toxicity and other safety testing required by legislation’ and ‘legislative requirements’ apply only to ‘toxicity and other safety testing including pharmacology’ and not to all other subcategories of ‘regulatory use and routine production by type’. In order to clarify this issue the layout of the flowchart should be changed. To emphasise this further, the title of input category ‘toxicity and other safety testing required by legislation’ should be changed to ‘testing by legislation’. Other minor changes to the layout of the flowchart should be introduced in order to improve clarity.

(2) Changes made to the flowchart should be mirrored in the second part of Annex II to Implementing Decision 2012/707/EU, containing the detailed instructions.

(3) Implementing Decision 2012/707/EU should therefore be corrected accordingly.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 56(1) of Directive 2010/63/EU,

HAS ADOPTED THIS DECISION:

Article 1

Annex II to Implementing Decision 2012/707/EU shall be replaced by the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 20 December 2013.

For the Commission

Janez POTOČNIK

Member of the Commission

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

(2) Commission Implementing Decision 2012/707/EU 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 laboratory animals used for scientific purposes (OJ L 320, 17.11.2012, p. 33).

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ANNEX

‘ANNEX II

PART A

FLOWCHART OF STATISTICAL DATA INPUT CATEGORIES UNDER ARTICLE 54(2)

PART B

DETAILED INSTRUCTIONS FOR THE PROVISION OF STATISTICAL DATA ON THE USE OF ANIMALS FOR SCIENTIFIC PURPOSES UNDER ARTICLE 54(2)

REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(2) OF DIRECTIVE 2010/63/EU

1. The data should be entered on each use of an animal.

2. When entering data for an animal, only one option within a category can be selected.

3. Animals killed for organs and tissues, as well as sentinels, are excluded from the provision of statistical data, unless the killing is performed under a project authorisation using a method not included in Annex IV or where the animal has gone through a previous intervention, prior to being killed, and which has been above the threshold of minimum pain, suffering, distress and lasting harm.

4. Surplus animals that are killed are not included in the statistical data apart from genetically altered animals with intended and exhibited harmful phenotype.

5. Larval forms of animals are to be counted once they become capable of independent feeding.

6. Foetal and embryonic forms of mammalian species are not counted; only animals that are born, including by Caesarean section, and live, are to be counted.

7. Whenever the “severe” classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported normally like any other use, and under the “severe” category. Commentary should be added in the “Member State” narrative section covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why “severe” classification was exceeded.

8. The data are to be reported for the year that the procedure ends. In case of studies running across 2 calendar years, all of the animals may be accounted for together in the year in which the last procedure ends if this exemption to annual reporting is authorised by the competent authority. For projects running longer than 2 calendar years, animals are reported on the year they are killed or die.

9. The use of “other” category requires a compulsory entry in the narratives to provide further details.

A. GENETICALLY ALTERED ANIMALS

1. For the purposes of statistical reporting, “genetically altered animals” include genetically modified (transgenic, knock-out and other forms of genetic alteration) and naturally occurring or induced mutant animals.

2. Genetically altered animals are reported either: (a) when used for the creation of a new line; (b) when used for the maintenance of an established line with an intended and exhibited harmful phenotype; or (c) when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

3. All animals carrying the genetic alteration should be reported during the creation of a new line. In addition, those used for superovulation, vasectomy, embryo implantation should equally be reported (these may or may not be genetically altered themselves). Genetically normal animals (wild type offspring) produced as a result of creation of a new genetically altered line should not be reported.

4. In the category “Purposes”, the animals used for the creation of a new genetically altered line should be reported under “basic research” or “translational and applied research” in the respective category the line is being created for.

5. A new strain or line of genetically altered animals is considered to be “established” when transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

6. The welfare assessment will determine if the newly created line is expected to have an intended harmful phenotype and, if this is the case, the animals from this point onwards shall be reported under category “Maintenance of colonies of established genetically altered animals, not used in other procedures” — or, if appropriate, in the other procedures they are being used for. If the welfare assessment concludes that the line is not expected to have a harmful phenotype, its breeding falls outside the scope of a procedure and no longer needs to be reported.

7. “Maintenance of colonies of established genetically altered animals, not used in other procedures” contains the animals required for the maintenance of colonies of genetically altered animals of established lines with an intended harmful phenotype and which have exhibited pain, suffering, distress or lasting harm as a consequence of the harmful genotype. The intended purpose for which the line is being maintained for is not recorded.

8. All genetically altered animals which are used in other procedures (not for the creation or maintenance of a genetically altered line) should be reported under their respective purposes (the same way as any non-genetically altered animal). These animals may or may not exhibit a harmful phenotype.

9. Genetically altered animals, expressing a harmful phenotype, and killed for their organs and tissue, should be reported under the respective primary purposes for which the organs/tissue were used.

B. DATA CATEGORIES

The sections below follow the order of the categories and related headings in the flow chart.

1. Type of animal

(i) All cephalopod species are to be reported under heading cephalopod from the stage at which the animal becomes capable of independent feeding, i.e. immediately post-hatching for octopus and squid; and around 7 days after hatching for cuttlefish.

(ii) Fish should be counted from the stage of being capable of independent feeding onward. Zebrafish kept in optimal breeding conditions (approximately + 28 °C) should be counted 5 days post fertilisation.

(iii) Due to the small size of some fish and cephalopod species, the count may be done on the basis of estimation.

2. Reuse

(i) Each use of the animal should be reported at the end of each procedure.

(ii) The statistics will present the number of naïve animals only in connection with their species and place of birth. For reused animals, their “place of birth” is therefore not recorded.

(iii) Any subsequent categories will show the number of uses of animals in procedures. Thus these numbers cannot be cross referenced with the total numbers of naïve animals.

(iv) The number of animals that are reused cannot be deduced from the data due to the fact that some animals may be reused more than once.

(v) The actual suffering of the animal in the procedure should be reported. In some cases this could be influenced by a previous use. However, the severity will not always increase in a subsequent use and in some cases even decrease as a result (habituation). Therefore there should be no attempt to

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