Registration vs approval of food establishments

Two distinct regimes

Article 6 of Regulation (EC) 852/2004 governs the administrative start-up of food establishments on two levels, alternative to each other depending on risk: registration (paragraph 2) and approval (paragraph 3). They are not two names for the same thing: they are two regimes with different conditions, procedure and effects.

Registration (Article 6(2))

Registration is the general rule. Every operator notifies the competent authority, in the manner it requires, of each establishment under its control carrying out any of the stages of production, processing and distribution of food, with a view to its registration Article 6(2) of Regulation (EC) No 852/2004. It is an act of notification, not of authorisation: the activity may start without waiting for an enabling measure, subject to any national rules. The operator must also keep the information up to date, notifying any significant change in activities and any closure Article 6(2) of Regulation (EC) No 852/2004. In Italy registration is generally made through a health SCIA (see the country pages); the general operational path is set out in the obligations.

Approval (Article 6(3))

Approval is a prior authorisation. Operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, where approval is required: (a) under the national law of the Member State; (b) under Regulation (EC) No 853/2004; or (c) by a Commission decision Article 6(3) of Regulation (EC) No 852/2004. The substantive difference from registration is twofold: a prior inspection is required and, for the categories concerned, the activity may not start before the measure is granted.

The typical scope is establishments handling products of animal origin — meat, fishery products, milk and dairy products, eggs — governed by Regulation (EC) 853/2004, which requires approval save for the exceptions it provides Article 4 of Regulation (EC) No 853/2004. A Member State requiring the approval of certain establishments under national law informs the Commission and other Member States of those rules Article 6(3) of Regulation (EC) No 852/2004.

The identification mark (oval EC mark)

The competent authority assigns approved establishments an approval number. Products of animal origin placed on the market by such establishments bear an identification mark — the characteristic oval mark showing the country code and the establishment's approval number — applied in accordance with Annex II, Section I, of Regulation (EC) 853/2004 Article 5 of Regulation (EC) No 853/2004. The mark is not a commercial logo or a quality certification: it attests that the product comes from an approved establishment subject to official controls Article 9 of Regulation (EU) 2017/625. Establishments subject to registration only do not apply the oval mark.

Comparison table

Some establishments are subject to both regimes for different activities; others, handling products of animal origin only marginally at retail level, may remain under registration only by virtue of the exemptions in Regulation (EC) 853/2004 Article 1 of Regulation (EC) No 853/2004. The classification must be checked case by case: application diverges between Member States and must be compared with national rules (see country pages).