1.

Competent authorities shall only grant approval of establishments as provided for in Article 94(1) and point (a) of Article 95 where such establishments: comply with the following requirements, where appropriate, in relation to: quarantine, isolation and other biosecurity measures taking into account the requirements provided for in point (b) of Article 10(1) and any rules adopted pursuant to Article 10(2); surveillance requirements as provided for in Article 24 and, where relevant for the type of establishment concerned and the risk involved, in Article 25; record-keeping as provided for in Articles 102 and 103 and any rules adopted pursuant to Articles 106 and 107; have facilities and equipment that are: adequate to reduce the risk of the introduction and spread of diseases to an acceptable level, taking into account the type of establishment concerned; of a capacity adequate for the number of kept terrestrial animals or the volume of germinal products concerned; do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place; have adequately trained personnel for the activity of the establishment concerned; have in place a system which enables the operator concerned to demonstrate to the competent authority compliance with points (a) to (d).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.