Implementing decision 2012/707 - 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 on the protection of animals used for scientific purposes (notified under document C(2012) 8064) - Main contents

EN

Official Journal of the European Union

L 320/33

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.

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.

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.

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.

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.

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.

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.

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.

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,

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

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

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);

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

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

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

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.

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

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

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.

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.

The data are to be reported for the year that the procedure ends. In case of studies running across two 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 two calendar years, animals are reported on the year they are killed or die.

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

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.

Genetically altered animals are reported either

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.

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.

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.

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.

‧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.

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.

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.

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 seven days after hatching for cuttlefish.

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

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

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

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.

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.

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.

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 automatically add up the severities from its previous uses. This should always be judged on a case-by-case basis.

Origin is based on the place of birth i.e. "born in" and not according to where the animal is supplied from.

Animals born in the EU at a registered breeder covers animals born at breeders as authorised and registered under Article 20 of Directive 2010/63/EU.

Animals born in the EU but not at a registered breeder includes animals born outside a registered breeder such as wild animals, farm animals (unless the breeder is authorised and registered), as well as any exemptions granted under Article 10(3) of Directive 2010/63/EU.

Animals born in rest of Europe and Animals born in rest of world groups together all animals regardless of whether they have been bred in registered breeding establishments, other establishments and includes animals that have been captured in the wild.

Animals born in rest of Europe is to include animals born in Turkey, Russia and Israel.

Animals born in Asia is to include animals born in China.

Animals born in America is to include animals born in the North, Central and South America.

Animals born in Africa is to include animals born in Mauritius.

Animals born elsewhere is to include animals born in Australasia.

As long as the colony is not self-sustained, animals born in that colony should be reported under F0, F1, F2 or greater according to their generation derived from the maternal line.

Once the whole colony is self-sustained, all animals born in that colony should be reported under Self-sustaining colony regardless of their generation derived from the maternal line.

Not genetically altered covers all animals that have not been genetically altered, including genetically normal parent animals used for the creation of a new genetically altered animal line/strain.

Genetically altered without a harmful phenotype includes animals used for the creation of a new line, carrying the genetic alteration but exhibiting no harmful phenotype and genetically altered animals used in other procedures (not for creation or maintenance) but exhibiting no harmful phenotype.

Genetically altered with a harmful phenotype includes:

Non-recovery – Animals which have undergone a procedure that has been performed entirely under general anaesthesia from which the animal has not recovered consciousness shall be reported as non-recovery.

Mild (up to and including) - Animals which have undergone a procedure as a result of which the animals have experienced up to, and including, short-term mild pain, suffering or distress, as well as when there has been no significant impairment of the well-being or general condition of the animals shall be reported as Mild. N.B. This should also include any animals used in an authorised project, but which have ultimately not been observed to have experienced a level of pain, suffering, distress or lasting harm equivalent to that caused by the introduction of a needle in accordance with good veterinary practice, with the exception of animals required for the maintenance of colonies of genetically altered animals of established lines with an intended harmful phenotype and which have not exhibited pain, suffering, distress or lasting harm as a consequence of the harmful genotype.

Moderate - Animals which have undergone a procedure as a result of which the animals have experienced short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that have caused moderate impairment of the well-being or general condition of the animals shall be reported as Moderate.

Severe - Animals which have undergone a procedure as a result of which the animals have experienced severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that have caused severe impairment of the well-being or general condition of the animals shall be reported as Severe.

If the ‧severe‧ classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported under Severe. 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.

Use of animals in procedures carried out with a view to satisfying legal requirements for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed.

This includes tests carried out on products/substances for which no regulatory submission is made (i.e. tests performed on those products/substances (for which a regulatory submission was foreseen) that are ultimately deemed unsuitable for the market by the developer, and thus fail to reach the end of the development process).

This category also includes animals used in the manufacturing process of products if that manufacturing process requires regulatory approval (e.g. animals used in the manufacturing of serum-based medicinal products should be included within this category).

Efficacy testing during the development of new medicinal product is excluded and should be reported under category "Translational and Applied research".

Quality control includes animals used in the testing of purity, stability, efficacy, potency and other quality control parameters of the final product and its constituents and any controls carried out during the manufacturing process for registration purposes, to satisfy any other national or international regulatory requirements or to satisfy the in-house policy of the manufacturer. This includes pyrogenicity testing.

Other efficacy and tolerance testing Efficacy testing of biocides and pesticides is covered under this category as well as the tolerance testing of additives in animal nutrition.

Routine production covers the production of monoclonal antibodies (by ascites) and blood products including polyclonal antisera by established methods. This excludes immunisation of animals for hybridoma production which should be captured under basic or applied research under the appropriate category.

Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine) covers studies carried out on any product or substance to determine its potential to cause any dangerous or undesirable effects in humans or animals as a result of its intended or abnormal use, manufacture or as a potential or actual contaminant in the environment.

The legislative requirement should be entered as per the intended primary use.

Water quality; if concerning e.g. tap water to be reported under food legislation

This category allows identification of the level of harmonisation between different legislative requirements. The determining factor is not who requests the test to be carried out but which legislation is satisfied, giving priority to the widest level of harmonisation.

Where national legislation is derived from EU legislation, only Legislation satisfying EU requirements is to be chosen.

Legislation satisfying EU requirements also includes any international requirement which at the same time satisfies EU requirements (such as testing to ICH, VICH, OECD guidelines, European Pharmacopoeia monographs).

Legislation satisfying national requirements only (within EU) is to be chosen only when the test is carried out to satisfy the requirements of one or more Member State; not necessarily the one in which the work is being carried out. However, there is no equivalent requirement in the EU.

Legislation satisfying Non-EU requirements only is to be chosen when there is no equivalent requirement to carry out the test to satisfy EU requirements.

Immunotoxicology studies should be covered under Repeated dose toxicity.

Kinetics (pharmacokinetics, toxicokinetics, residue depletion) if toxicokinetics is performed as part of the regulatory repeat dose toxicity study, it should be reported under repeated dose toxicity.

Safety testing in the food and feed area includes testing of drinking water (including target animal safety testing).

Target animal safety this is testing to ensure a product for a specific animal can be used safely on that species (excluding batch safety testing which is covered under quality control).

General information on any changes in trends observed since the previous reporting period.

Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

Information on any changes in trends in actual severities and analysis of the reasons thereof.

Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

Details on cases where the ‧severe‧ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.