2. The legislative requirement and purpose of approval
2.1. Regulation (EC) 853/2004 requires that food business establishments handling food of animal origin that fall under the categories for which Annex III (see table 1 in Annex 1) stipulates requirements must, with some limited exceptions, be approved by the CA. Compliance with the relevant requirements of Regulation (EC) 853/2004 is required in addition to full compliance with Regulation (EC) 852/2004. Registration under Article 6(2) of Regulation (EC) 852/2004 is not required for approved establishments.
2.2. Establishments that require approval must be approved prior to commencing activities or operating in a manner that requires approval. Where an establishment is identified as trading without the necessary approval, appropriate action (including, where necessary, formal enforcement action) should be taken to ensure that activity which requires approval ceases immediately.
Consideration should also be given to dealing with food already placed on the market.