Registration and health SCIA in Italy (Reg. 852/2004)

What the health SCIA is

The European basis is Article 6 of Reg. 852/2004: every food business operator must notify to the competent authority, for registration, each establishment under its control, as well as any significant change and the cessation of the activity Article 6(2) of Regulation (EC) No 852/2004. Italy gives effect to this obligation through the certified notification of business commencement (SCIA) for health purposes, filed electronically with the territorially competent municipal One-Stop Shop for Productive Activities (SUAP), under the procedural scheme of Presidential Decree No 160 of 7 September 2010. The SUAP forwards the notification to the ASL/ATS, which carries out the controls within its remit.

The SCIA is a declaration, not an authorisation: the activity may start from the filing date. This is consistent with the nature of registration described by the regulation, which does not make commencement conditional on a prior act of assent Article 6(2) of Regulation (EC) No 852/2004. The ASL retains the power of subsequent control and, where shortcomings are found, may prescribe corrective measures or halt the activity.

What you need beforehand

Registration is not an isolated step: it presupposes that the business already complies with the substantive obligations of the Hygiene Package. Before or together with the SCIA you must:

• have put in place self-checking procedures based on HACCP principles Article 5(1) of Regulation (EC) No 852/2004, formalised in the food safety management manual;
• have ensured the training of staff handling food Annex II, Chapter XII, point 1 of Regulation (EC) No 852/2004, under the rules of your Region (see training under Annex II, Chapter XII);
• have premises and equipment compliant with the structural requirements of Annex II of the regulation Annex II, Chapter I, point 1 of Regulation (EC) No 852/2004.

The European basis of the obligation is in Article 6 of Reg. 852/2004, read together with the self-checking obligation of Article 5.

Unified forms, but with local variants

To reduce fragmentation, the Unified State-Regions-Local Authorities Conference adopted standardised SCIA forms, transposed by the Regions. In theory the template is single; in practice required attachments, floor plans, technical reports and processing fees vary from municipality to municipality and from region to region. In our view it is essential to check the SUAP portal of the specific municipality before preparing the file: relying on a generic template found online is the main cause of requests for supplementary documents.

Registration or approval?

This is the most important distinction. Registration (SCIA) covers the generality of food activities — restaurants, bars and cafes, bakeries, shops, food trucks — which do not require a prior act of assent Article 6(2) of Regulation (EC) No 852/2004. Approval, by contrast, is a separate authorisation procedure required for establishments producing or processing products of animal origin governed by Reg. (EC) 853/2004 (slaughterhouses, dairies, cutting plants, some meat and fishery processing plants) Article 4 of Regulation (EC) No 853/2004. Approval involves a prior on-site inspection by the ASL, the opinion of the Region and the assignment of an approval number (health mark) after issue, often preceded by conditional approval. The conceptual difference is examined in registration vs approval.

There are marginal, localised and restricted activities and forms of direct sale by the primary producer that follow simplified rules: even in these cases, however, the obligation to notify for registration remains, save for the exclusions provided by law Article 1(2) of Regulation (EC) No 852/2004.

Typical costs and timeframes

The picture must be read with caution, because it depends on the local authority. In general terms:

• Costs. The SCIA itself has no national "price": you pay any SUAP processing fees and the ASL health fees, which vary (from a few tens to a few hundred euro depending on municipality and activity type), plus stamp duty where due.
• Timeframes. Registration through SCIA takes immediate effect: there is no waiting time to start. Approval under Reg. 853/2004, by contrast, requires prior processing and inspection and may take weeks or months Article 4 of Regulation (EC) No 853/2004.

Because amounts and attachments are not uniform, we give orders of magnitude rather than exact figures: the binding source is always the SUAP portal of the competent municipality.