PART IV

REGISTRATION, APPROVAL, TRACEABILITY AND MOVEMENTS
TITLE I

TERRESTRIAL ANIMALS, GERMINAL PRODUCTS AND PRODUCTS OF ANIMAL ORIGIN FROM TERRESTRIAL ANIMALS
CHAPTER 1

Registration, approval, record-keeping and registers
Section 2

Approval of certain types of establishments

Granting of, and conditions for, approval of establishments and delegated acts
Article 97
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:
a
comply with the following requirements, where appropriate, in relation to:
1. 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);
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;
3. record-keeping as provided for in Articles 102 and 103 and any rules adopted pursuant to Articles 106 and 107;
b
have facilities and equipment that are:
1. adequate to reduce the risk of the introduction and spread of diseases to an acceptable level, taking into account the type of establishment concerned;
2. of a capacity adequate for the number of kept terrestrial animals or the volume of germinal products concerned;
c
do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;
d
have adequately trained personnel for the activity of the establishment concerned;
e
have in place a system which enables the operator concerned to demonstrate to the competent authority compliance with points (a) to (d).
2
The Commission shall adopt delegated acts in accordance with Article 264 concerning:
a
quarantine, isolation and other biosecurity measures as referred to in point (a)(i) of paragraph 1;
b
surveillance as referred to in point (a)(ii) of paragraph 1;
c
facilities and equipment as referred to in point (b) of paragraph 1;
d
responsibilities, competence and specialised training of personnel and veterinarians as provided for in point (d) of paragraph 1 for the activity of germinal products establishments and establishments for assembly operations of ungulates and poultry;
e
the necessary supervision by the competent authority of germinal products establishments and establishments for assembly operations of ungulates and poultry.
3
When establishing the rules to be laid down in the delegated acts to be adopted pursuant to paragraph 2, the Commission shall base those rules on the following matters:
a
the risks posed by each type of establishment;
b
the species and categories of kept terrestrial animals relevant for the approval;
c
the type of production concerned;
d
typical movement patterns of the type of establishment and species and categories of animals kept in those establishments.