Regulation (EU) 2016/429 of the European Parliament and of the CouncilShow full title

Section 2 U.K. Approval of certain types of aquaculture establishments

Article 176U.K.Approval of certain aquaculture establishments and delegated acts

1.Operators of the following types of aquaculture establishments shall apply to the competent authority for approval in accordance with Article 180(1):

(a)aquaculture establishments where aquaculture animals are kept with a view to their being moved therefrom, either alive or as products of aquaculture animal origin;

(b)other aquaculture establishments which pose a significant risk due to:

2.By way of derogation from paragraph 1, Member States may exempt from the obligation to apply for approval operators of the following types of establishment:

(a)aquaculture establishments producing a small quantity of aquaculture animals for supply for human consumption either:

(b)ponds and other installations where the population of aquatic animals is maintained only for recreational fishing purposes, by restocking with aquaculture animals which are confined and unable to escape;

(c)aquaculture establishments keeping aquaculture animals for ornamental purposes in closed facilities,

provided that the establishment in question does not pose a significant risk.

3.Unless a derogation has been granted under paragraph 4 of this Article, operators shall not commence activity at an aquaculture establishment as referred to in paragraph 1 of this Article until that establishment has been approved in accordance with Article 181(1), and shall cease such activity at an aquaculture establishment referred to in paragraph 1 of this Article where:

(a)the competent authority withdraws or suspends its approval in accordance with Article 184(2); or

(b)in the event of conditional approval, granted in accordance with Article 183(3), the aquaculture establishment concerned fails to comply with the outstanding requirements referred to in Article 183(4) and does not obtain a final approval in accordance with Article 183(3).

4.The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning:

(a)derogations from the requirement for operators to apply to the competent authority for approval of the types of aquaculture establishments referred to in point (a) of paragraph 1, concerning types of establishments other than those specified in points (a)(i) and (ii) of paragraph 2, where those establishments do not pose a significant risk;

(b)the types of aquaculture establishments which must be approved in accordance with point (b) of paragraph 1.

5.When adopting delegated acts as provided for in paragraph 4, the Commission shall base those acts on the following criteria:

(a)the species and categories of aquaculture animals kept in an aquaculture establishment;

(b)the type of aquaculture establishment and the type of production; and

(c)typical movement patterns of the type of aquaculture establishment concerned and of the species or category of aquaculture animals concerned.

6.An operator may apply for approval of a group of aquaculture establishments, provided that the requirements provided for in points (a) and (b) of the first paragraph of Article 177 are complied with.

Article 177U.K.Approval by the competent authority of groups of aquaculture establishments

The competent authority may grant approval as provided for in Article 181(1) covering a group of aquaculture establishments, provided that the aquaculture establishments in question comply with either of the following conditions:

When a single approval is granted for a group of aquaculture establishments, the rules laid down in Article 178 and Articles 180 to 184 and the rules adopted pursuant to Articles 180(2) and 181(2), which are applicable to a single aquaculture establishment, shall be applicable to the whole group of aquaculture establishments.

Article 178U.K.Approval of status of confined aquaculture establishments

Operators of aquaculture establishments wishing to obtain the status of a confined establishment shall:

Article 179U.K.Approval of disease control aquatic food establishments

Operators of disease control aquatic food establishments shall:

Article 180U.K.Obligation of operators to provide information with a view to obtaining approval

1.Operators shall, for the purposes of their application for approval of their establishment as provided for in Article 176(1), Article 177, point (a) of Article 178 and Article 179, provide the competent authority with the following information:

(a)the name and address of the operator concerned;

(b)the location of the establishment concerned and a description of its facilities;

(c)the species, categories and quantities (numbers, volume or weight) of aquaculture animals relevant for the approval which are kept on the establishment;

(d)the type of aquaculture establishment;

(e)in cases of approval of a group of aquaculture establishments, details showing that the group in question complies with the conditions laid down in Article 177;

(f)other aspects of the mode of operation of the aquaculture establishment in question which are relevant for determining the risk, posed by it;

(g)the water supply to, and discharge of water from, the establishment;

(h)the establishment's biosecurity measures.

2.Operators of establishments as referred to in paragraph 1 shall inform the competent authority in advance of:

(a)any changes in the establishments concerning the matters referred to in paragraph 1;

(b)any cessation of activity by the operator or establishment concerned.

3.The Commission may, by means of implementing acts, lay down rules concerning the information to be provided by operators in their application for approval of their establishment, in accordance with paragraph 1, including the time-limits by which such information is to be provided.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 266(2).

Article 181U.K.Granting of, and conditions for, approval and delegated acts

1.The competent authority shall only grant approvals of aquaculture establishments as referred to in Article 176(1) and point (a) of Article 178, groups of aquaculture establishments as referred to in Article 177 and disease control aquatic food establishments as referred to in Article 179, where such establishments:

(a)comply with the following requirements, where appropriate, in relation to:

(b)have facilities and equipment that are:

(c)do not pose an unacceptable risk as regards the spread of diseases, taking into account the risk-mitigation measures in place;

(d)have in place a system which enables the operator concerned to demonstrate to the competent authority that the requirements laid down in points (a), (b) and (c) are fulfilled.

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.

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 aquaculture or aquatic animals relevant for the approval;

(c)the type of production concerned;

(d)typical movement patterns of the type of aquaculture establishment and species and categories of animals kept in those establishments.

Article 182U.K.Scope of the approval of establishments

The competent authority shall expressly specify in the approval of an aquaculture establishment or a disease control aquatic food establishment granted pursuant to Article 181(1) following an application made in accordance with Article 176, Article 177, point (a) of Article 178 or Article 179:

Article 183U.K.Procedures for the granting of approval by the competent authority

1.The competent authority shall establish procedures for operators to follow when applying for approval of their establishments in accordance with Article 176(1) and Articles 178 and 179.

2.Upon receipt of an application for approval from an operator in accordance with Article 176(1), Article 178 or Article 179, the competent authority shall make an on–site visit.

3.Provided that the requirements referred to in Article 181 are fulfilled, the competent authority shall grant the approval.

4.Where an establishment does not fulfil all requirements for approval as referred to in Article 181, the competent authority may grant conditional approval of an establishment if it appears, on the basis of the application by the operator concerned and the subsequent on-site visit provided for in paragraph 2 of this Article, that the establishment meets all the main requirements that provide sufficient guarantees that the establishment does not pose a significant risk.

5.Where conditional approval has been granted by the competent authority in accordance with paragraph 4 of this Article, it shall grant full approval only where it appears from another on–site visit to the establishment, carried out within three months from the date of the grant of conditional approval, or from documentation provided by the operator within three months from that date, that the establishment meets all the requirements for approval provided for in Article 181(1) and the rules adopted pursuant to Article 181(2).

Where the on–site visit or the documentation referred to in the first subparagraph shows that clear progress has been made but that the establishment still does not meet all of those requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not be granted for a period exceeding, in total, six months.

Article 184U.K.Review, suspension and withdrawal of approvals by the competent authority

1.The competent authority shall keep approvals of establishments granted in accordance with Article 181(1) under review, at appropriate intervals based on the risk involved.

2.Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 181(1) and the rules adopted pursuant to Article 181(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment.

However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time.

3.Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.