1.(a)When Community legislation requires the approval of establishments, the competent authority shall make an on-site visit. It shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it meets the relevant requirements of Regulations (EC) No .../2004(1) and No .../2004(2) and other relevant requirements of food law.
(b)The competent authority may grant conditional approval if it appears from the on-site visit that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new on-site visit carried out within three months of the granting of conditional approval that the establishment meets the other requirements referred to in (a). If clear progress has been made but the establishment still does not meet all of these requirements, the competent authority may prolong conditional approval. However, conditional approval shall not exceed a total of six months.
2.In the case of factory and freezer vessels flying the flag of Member States, the maximum periods of three and six months applying to the conditional approval of other establishments may be extended, if necessary. However, conditional approval shall not exceed a total of 12 months. Inspections of such vessels shall take place as specified in Annex III.
3.The competent authority shall give each approved establishment, including those with conditional approval, an approval number, to which codes may be added to indicate the types of products of animal origin manufactured. For wholesale markets, secondary numbers indicating units or groups of units selling or manufacturing products of animal origin may be added to the approval number.
4.(a)The competent authority shall keep the approval of establishments under review when carrying out official controls in accordance with Articles 4 to 8.
(b)If the competent authority identifies serious deficiencies or has to stop production at an establishment repeatedly and the food business operator is not able to provide adequate guarantees regarding future production, the competent authority shall initiate procedures to withdraw the establishment's approval. However, the competent authority may suspend an establishment's approval if the food business operator can guarantee that it will resolve deficiencies within a reasonable time.
(c)In the case of wholesale markets, the competent authority may withdraw or suspend approval in respect of certain units or groups of units.
5.Paragraphs 1, 2 and 3 shall apply both:
(a)to establishments that begin placing products of animal origin on the market on or after the date of application of this Regulation; and
(b)to establishments already placing products of animal origin on the market but in respect of which there was previously no requirement for approval. In the latter case, the competent authority's on-site visit required under paragraph 1 shall take place as soon as possible.
Paragraph 4 shall also apply to approved establishments that placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation.
6.Member States shall maintain up-to-date lists of approved establishments, with their respective approval numbers and other relevant information, and make them available to other Member States and to the public in a manner that may be specified in accordance with the procedure referred to in Article 19(2).
Note for the Official Journal: insert number of Regulation on the hygiene of foodstuffs (see recital 1, 1st Regulation).
Note for the Official Journal: insert number of Regulation laying down specific hygiene rules for food of animal origin (see recital 1, 2nd Regulation).