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Establishments Subject to Approval

Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) 852/2004. They apply to unprocessed and processed products of animal origin.

Products of animal origin include live bivalve molluscs, live echinoderms, live tunicates, live marine gastropods and fishery products intended for human consumption.

Article 4(2) of Regulation (EC) No 853/2004 states:

that establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article.

Annex III of Regulation (EC) No 853/2004 lays down requirements for Live Bivalve Molluscs (Section VII) and Fishery Products (Section VIII), therefore food businesses carrying out activities that fall under Annex III Section VII and VIII are subject to approval. The requirement for the approval of such establishments is transposed into national legislation in Regulation 5(4) of S.I. No. 22 of 2020 and the Sea Fisheries Protection Authority is the competent authority for granting these approvals.

The types of aquaculture food businesses that require approval include:

  • auction halls
  • dispatch centres
  • factory vessels
  • freezer vessels
  • fresh fishery products plant
  • purification plants
  • processing plants
  • cold storage

View the list of approved establishments.

Aquaculture food businesses that do not require approval include:

  • establishments carrying out primary production only (as defined in Article 3 (17) of Regulation (EC) No 178/2002);
  • operations consisting solely of storage not requiring temperature-controlled conditions;
  • transport operations;
  • retail direct to the final consumer.

Such establishments however are subject to Article 6 of Regulation (EC) 852/2004, i.e., they must be registered with the relevant competent authority for their activities. This is transposed into national legislation in Regulation 4(2)(b) of S.I. No. 22 of 2020.