Regulation (EU) 2019/4 CHAPTER III — APPROVAL OF ESTABLISHMENTS

Article 13–Article 15 · 3 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Approval obligations

Article 13

1. Feed business operators manufacturing, storing, transporting or placing on the market medicated feed or intermediate products shall ensure that establishments under their control are approved by the competent authority. 2. Paragraph 1 shall not apply to the following feed business operators: (a) those who only buy, store or transport medicated feed for the exclusive use on their farm; (b) those who act solely as traders, without holding the medicated feed or intermediate products in their premises; (c) those who only transport or store medicated feed or intermediate products exclusively in sealed packages or containers. 3. The competent authority shall approve establishments only where an on-site visit, prior to start-up of the relevant activity, has demonstrated that the system put in place for the manufacture, storage, transport or placing on the market of medicated feed or intermediate products meets the specific requirements of Chapter II. 4. In the event that mobile mixers place medicated feed on the market in a Member State different from the one where they are approved, such mobile mixers shall notify that activity to the competent authority in the Member State where the medicated feed is placed on the market. 5. In respect of retailers of medicated feed for pets and keepers of fur animals feeding animals with medicated feed, Member States shall have in place national procedures to ensure that relevant information regarding their activities is available to the competent authorities, while avoiding duplication and unnecessary administrative burden.

Lists of approved establishments

Article 14

The establishments approved in accordance with Article 13(1) of this Regulation shall be recorded in a national list, as referred to in Article 19(2) of Regulation (EC) No 183/2005, under an individual identifying number attributed in the form set out in Chapter II of Annex V to that Regulation.

Transitional measures concerning the implementation of the requirements for approval and registration

Article 15

1. Establishments falling within the scope of this Regulation which have already been approved in accordance with Directive 90/167/EEC or otherwise authorised by the competent authority for activities falling within the scope of this Regulation may continue their activities subject to the submission, by 28 July 2022, of a declaration to the relevant competent authority in the area where their facilities are located, in a form decided upon by that competent authority, that they meet the requirements for approval referred to in Article 13(3) of this Regulation. 2. Where the declaration referred to in paragraph 1 of this Article is not submitted within the period specified, the competent authority shall suspend the existing approval in accordance with the procedure referred to in Article 14 of Regulation (EC) No 183/2005.

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