adopted by the Multilateral Consultation of the Parties to the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes on 27 November 1992

The Parties to the European Convention for the protection of vertebrate animals used for experimental or other scientific purposes, by virtue of the terms of reference laid down in its Article 30;

Recognising that these terms of reference imply the monitoring of the implementation of the provisions, the adaptation of the Convention to changing circumstances and new scientific evidence and the development of common and coordinated programmes in the field covered by the Convention;

Recognising also that the absence of a common interpretation of certain provisions and terms of the Convention may lead to considerable differences in the legal interpretation of the Convention by individual Contracting Parties and may hamper the effectiveness of the implementation of the Convention;

Considering that acquired experience and new scientific developments, since 1986, especially in the field of biotechnology, also require agreement on a common interpretation of some expressions in the Convention;

Convinced that an agreement on the interpretation of certain provisions and terms, particularly in Article 1, and the presentation of tables of Appendix B, will enable the achievement of an harmonisation of the implementation of the Convention and facilitate the development of common and co-ordinated programmes in the field covered by the Convention;

Have agreed on the following issues:

SCOPE OF THE CONVENTION WITH RESPECT TO ANIMALS CARRYING HARMFUL GENETIC MODIFICATIONS

(1) For the purpose of the Convention, Parties understand the expression "animals carrying harmful genetic modifications" as referring to genetically engineered animals and mutant animals capable of producing as a consequence offspring likely to suffer significantly.

(2) Generating a transgenic strain is considered as constituting a procedure under Article 1, sub-paragraph 2 c.

(3) The breeding of animals carrying harmful genetic modifications may be considered on certain conditions to be determined by each Party as a procedure under Article 1, sub-paragraph 2 c. Such procedure must be carried out in accordance with the Convention.

(4) If the breeding of animals carrying harmful genetic modifications is not considered to be a procedure, Articles 14, 15 and 16 shall apply.

In respect of Article 5, the Parties are aware of the fact, as confirmed by the drafters of the Convention in paragraph 37 of the Explanatory Report, that the provisions in that Article apply to animals carrying harmful genetic modifications only to the extent that the breeder has the duty to do everything possible to ensure the animals' well-being under the conditions in which they have to be kept.

Registration of an establishment breeding animals carrying harmful genetic modifications requires that the responsible authorities shall ensure that:

a. the establishment is adequately equipped to breed and keep such animals in accordance with the requirements of the Convention;

b. the person in charge of the establishment has knowledge of the possible harmful effects of the genetic modification and also has the qualifications required to administer, or arrange for, suitable care for such animals;

c. the record which is kept of such animals shall supply, apart from the data required under Article 16, paragraph 2, information on the type of genetic modifications and their effects on the animals, the reproduction data, and the medical histories of such animals or groups of animals.

DEFINITIONS

A. For the purpose of Article 1:

(5) The Parties to the Convention consider the amount of pain, suffering or distress caused by the introduction of a needle into the body of an animal as illustrating the level at which the use of an animal becomes a "procedure". Some studies on the behaviour of animals may result in sufficient suffering or distress for the study to be considered as a procedure, even if it does not imply physical interference.

(6) The Parties consider as a "procedure":

- the use of animals as control animals when they may experience a level of pain, suffering or distress equivalent to, or higher than, that caused by the introduction of a needle;

- the use of animals in research on nutrition and feeding, when they may experience a level of pain, suffering or distress equivalent to, or higher than, that caused by the introduction of a needle [for example, blood sampling, deprivation of food];

- the use of animals for the production of serum.

(7) The Parties do not consider as a "procedure" the monitoring of genetic status or health of animals.

B. For the purpose of Appendix B:

(8) The Parties agree that the expression "used" in a procedure applies to an animal from the moment it is submitted for the first time to an intervention which may cause pain, suffering, distress or lasting harm. An animal is counted in the statistics only in the year in which the procedure starts.

(9) The Parties define as follows the expression "re-used":

If in the framework of one single procedure it is necessary for scientific reasons to make more than one intervention on the same animal, this is not regarded as re-use. However, if in the framework of two or more unrelated and independent procedures, the same animal is used whereas a different animal could equally well have been chosen, this second or subsequent use is regarded as re-use.

The Parties consider that this information should be collected, but without specification of the number of times that the same animal has been re-used. Re-use of an animal is counted in the column "re-used" only once in each year in which it is re-used.

TABLES OF APPENDIX B

(10) The Parties agree on the presentation of the tables of Appendix B as reproduced in the Appendix to this Resolution.

IMPLEMENTATION OF ARTICLES 27 AND 28

(11) Subject to the provisions under Article 3, Parties undertake to start, if they have not already done so, as of 1 January 1996, the collection of the information required in Article 27, paragraph 2, and to communicate such information, by means of the tables in Appendix B as re-modelled by the Multilateral Consultation, in the course of 1997.

They invite the other member States, in respect of which the Convention will become effective in the near future to present their statistics in the same way.

APPENDIX

TABLES OF APPENDIX B The numbers, kinds and sources of animals used in procedures during (year) in (Party)

¹ Directly or indirectly (see article 21 with the addition of Primates)

TABLE 2

The number of animals used in procedures for selected purposes
during (year) in (Party)

TABLE 3

The number of animals used in procedures for selected purposes for the protection of man, animals and the environment by toxicological or
safety evaluation during (year) in (Party)
(including safety evaluation of products or appliances for human and veterinary medicine)

¹ The primary purpose for which it will be used as envisaged at the time when testing was performed.

² When substances belonging to the categories in the other rows in this table require testing as contaminants (e.g. leakage or release leading to the pollution of the environment) this testing should be recorded in row 6.

TABLE 4

The number of animals used in procedures concerned with diseases and disorders¹
during (year) in (Party)

Note: When a procedure covers cancer under any item from 2 to 4, the cancer classification should take precedence.

¹ If the type of human disease or disorder is not precisely known, the data should be entered in row 4.

TABLE 5

The number of animals used in procedures required by law
during (year) in (Party)