Historial: en4R2004853

4. APPROVAL OF ESTABLISHMENTS (ARTICLE 4 OF THE REGULATION)

4.1. Establishments subject to approval

Establishments (except those carrying out only primary production, transport operations, the storage of products not requiring temperature controlled storage conditions or retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b)) handling those products for which Annex III of Regulation (EC) No 853/2004 lays down requirements must be approved. This entails a wide range of establishments, including establishments handling nonprocessed products and processed products of animal origin.

A non-exhaustive list of establishment categories subject to approval in accordance with Regulation (EC) No 853/2004 is given in Annex IV to the present document.

As retail (activities involving direct sale or supply of food of animal origin to the final consumer) is not covered by the scope of Regulation (EC) No 853/2004, the approval of retail establishments is not required under that Regulation.

4.2. The approval of small establishments

Additionally small establishments handling food of animal origin must be approved by the competent authority.

The approval requirements for such establishments are largely the requirements that applied already to them under the current rules. The new approval requirement should not therefore impose an important new burden provided these establishments already complied with the food hygiene rules applicable to them under the relevant Community rules (e.g. Directives 64/433/EEC and 77/99/EEC).

Remark:

Regulation (EC) No 853/2004 excludes retail (i.e. the handling and/or processing of food and its storage at the point of sale) from its scope. This means that where cheese is manufactured and sold at a retail premise (e.g. at the farm), these activities can be carried under the respect of the requirements laid down in Regulation (EC) No 852/2004 only, requiring registration but no approval.

4.3. Meat from animals slaughtered at the farm

Slaughter activities at the farm must be carried out in accordance with the appropriate requirements of Regulation (EC) No 852/2004 and with the specific food hygiene rules for meat production laid down in Regulation (EC) No 853/2004. This includes that the slaughter facilities must be approved by the competent authority.

Where it is felt that the infrastructural requirements of Regulations (EC) No 852/2004 and 853/2004 are disproportionate for on-the-farm slaughter Member States may adapt those requirements in accordance with the procedure laid down for that purpose in Article 13 of Regulation (EC) No 852/2004 and/or Article 10 of Regulation (EC) No 853/2004.

Remarks:

''*The direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer, fall outside the scope of Regulation (EC) No 853/2004. Member States shall establish national rules to ensure the safety of such meat (see Article1, paragraph (d) of the Regulation).

• In the case of “slaughter for private domestic consumption”, such activity is undertaken by a private person who cannot be considered as being a food business operator. In addition, meat resulting from such slaughter is not placed on the market. Slaughter for private domestic consumption falls therefore out of the scope of Regulations (EC) No 852/204 and 853/2004. Member States may have national rules in place with regard to this type of slaughter.''

4.4. The approval of cold stores

Article 1, paragraph 5(a) of Regulation (EC) No 853/2004 lays down that “Unless expressly indicated to the contrary, this Regulation shall not apply to retail”.

Since cold stores could be considered as retail establishments in the broader sense of the definition in Article 3, paragraph 7 of Regulation (EC) No 178/2002, one might conclude that cold stores are generally excluded from the scope of Regulation (EC) No 853/2004 and are therefore not the subject of approval by the competent authorities (see Article 1, paragraph 5(a) of Regulation (EC) No 853/2004).

However, with regard to cold storage, Regulation (EC) No 853/2004 lays down requirements which must be considered as expressly indicating that cold storage operations fall within the scope of the Regulation, e.g.:

• Annex III, Section I, Chapter VII of Regulation (EC) No 853/2004 contains requirements regarding cold storage for meat, and cold stores for meat are therefore establishments handling products for which Annex III to the Regulation lays down requirements. Such establishments shall not operate unless the competent authority has approved them;

• Article 4 of Regulation (EC) No 853/2004 expressly excludes storage of products not requiring temperature-controlled storage conditions from the approval obligations, it being understood that establishments proceeding to cold storage must be approved.

Cold stores must therefore be approved insofar as they are used in relation with activities for which Annex III of Regulation 853/2004 lays down requirements.

However, in the light of Article 1, paragraph 5(b), cold stores operated by genuine retail outlets not covered by the Regulation are not subject to the Regulation, and cold stores that are involved in wholesale operations which are physically limited to transport and storage, do not need to be approved but remain subject to the temperature requirements. When wholesale activities include more than storage and transport (for instance re-wrapping), the cold stores remain establishments to be approved in accordance with Article 4.

4.5. Re-wrapping establishments

Re-wrapping establishments proceed to the unwrapping of products of animal origin that were previously wrapped in another establishment. Such unwrapping and re-wrapping operations may be combined with operations such as slicing and cutting of food.

Re-wrapping establishments handle exposed products of animal origin. It must be considered that, when they handle products of animal origin that are covered in Annex III of the Regulation, they fall within the scope of Article 4, paragraph 2 of the Regulation. Their approval is therefore required. This is a logical approach since new hazards may be introduced at the level of such establishments.

In order to ensure traceability, food business operators should not place on the market products of animal origin handled in rewrapping establishments unless the identification mark of the rewrapping establishment is applied.

4.6. Wholesale markets

It appears from Article 3, paragraph 3 of Regulation (EC) No 854/2004 that wholesale markets manufacturing products of animal origin need approval before they can place on the market their products. Since in a wholesale market several infrastructures and equipment (e.g. water supply, cold stores) are shared by several units, it seems appropriate that a person/body is held responsible for ensuring that the hygiene requirements for those common infrastructures and equipment are met.