1.Member States shall ensure that authorisations, as provided for in Article 4(1) and (2), are only granted by the competent authority if the aquaculture production business operator or authorised processing establishment operator:
(a)fulfils the relevant requirements of Articles 8, 9 and 10;
(b)has a system in place which enables the operator to demonstrate to the competent authority that those relevant requirements are being fulfilled;
and
(c)remains under the supervision of the competent authority, which shall perform the duties laid down in Article 54(1).
2.Authorisation shall not be granted if the activity in question were to lead to an unacceptable risk of spreading diseases to farms, mollusc farming areas or to wild stocks of aquatic animals in the vicinity of the farm or mollusc farming area.
However, before a decision to refuse authorisation is taken, consideration shall be given to risk-mitigation measures, including possible alternative siting of the activity in question.
3.Member States shall ensure that the aquaculture production business operator or authorised processing establishment operator submits all relevant information in order to allow the competent authority to assess that the conditions for authorisation are fulfilled, including the information required in accordance with Annex II.