4. Establishments that require approval
4.1. Establishments that require approval are split between FSS and LAs depending upon whether veterinary supervision is required.
4.2. Abattoirs, Cutting Plants and Game Handling Establishments require veterinary control in accordance with Article 18 of Regulation (EU) 2017/625 and must, therefore, be approved and subject to enforcement by FSS.
4.3. When co-located with an Abattoir, Cutting Plant and/or a Game Handling Establishment, any Cold Store, Re-wrapping Establishment, Minced Meat, Meat Preparations, and Mechanically Separated Meat activities are also approved by FSS. When stand-alone, these establishments are approved by the relevant LA.
4.4. Other co-located approvable activities will be considered on a case-by-case basis. Where possible, the intention of the policy is to avoid having more than one approving authority (see 11.26) but discussion will be required between FSS and the relevant LA to agree responsibility for official control arrangements at such establishments.
4.5. Table 1 in Annex 1 of this document lists commodities and activities that require approval; the relevant section of Annex III of Regulation (EC) 853/2004, and the appropriate approval authority.
4.6. For establishments approved by FSS, the relevant LA will remain the enforcing authority for certain legislation. Further detail on the split in enforcement responsibility in such cases is provided in table 4 in Annex 1.
4.7. The approval of establishments relates to the food being processed and supplied from an establishment, not an intermediate step in the process. Therefore establishments involved in cutting meat as part of the process of manufacturing meat preparations, do not require cutting plant approval, but do require meat preparations approval. Likewise, an establishment making mince or meat preparations, as part of the process of manufacturing meat products does not require minced meat and meat preparations approval but does require meat products approval. The exemption to this, relates to abattoirs. The slaughter process requires approval irrespective of the product supplied from the establishment.
4.8. Collection centres and tanneries may supply raw material for the production of gelatine and collagen intended for human consumption. They are not subject to the requirements of Regulation (EC) 852/2004, nor are they subject to approval under Regulation (EC) 853/2004. They will, however, need to be specifically authorised by the relevant LA or FSS in accordance with Annex III, Section XIV, Chapter 1(5) of Regulation (EC) 853/2004 (gelatine) and Section XV Chapter 1(5) of Regulation (EC) 853/2004 (collagen).
Determining whether approval is required
4.9. Establishments handling food of animal origin must, with some limited exceptions, be approved by the CA.
4.10. A new approval is required whenever a new or existing food business establishment intends to undertake activities that require approval. In this regard, it is vitally important that the definition of an establishment is understood.
4.11. A food business establishment is defined as a unit of a food business. In this regard, it is distinctly different to a premises – which relates to the physical structure. In relation to approval, it should be considered to consist of a combination of the food business operator, the premises and the activity being conducted. Therefore, an approved establishment cannot change hands, as the new owner operating at the premises creates a new establishment and the previous establishment ceases to exist.
4.12. FSS should be consulted where there is any doubt about whether a new approval is required.
4.13. There are a number of scenarios that fit the criteria for requiring a new approval including:
- A new food business operator, at new premises.
- A new food business operator taking over a premises previously operated as an approved establishment by a different food business operator.
- An existing food business operator relocating to a new premises.
- An existing food business operator expanding/changing operations so that approval is required.
4.14. Where an FBO intends to process a new category of POAO, e.g. the addition of meat products to a meat preparation establishment, this would require a new approval. In addition, new approval will be required where significant changes within a category are planned, e.g. a fishery products establishment currently producing fishery products that require to be heat treated prior to consumption, that intends to produce RTE fishery products; or a manufacturer of pasteurised dairy products intends to produce unpasteurised cheese. The revised or new process should be subject to conditional approval, whilst the existing processes would remain under the existing full approval (See 7.24). Other changes that do not introduce significant new risks would be considered as a variation and would not require a new approval.