French Sanitary Approval: Is It Mandatory for Your Business? Who Is Covered

“Do I need sanitary approval?” Every founder of a food workshop, cannery, cheese dairy or central kitchen in France asks the question — and the answer hinges on a criterion many discover too late: who do you sell to? The agrément sanitaire (French sanitary approval) does not depend on the size of your company or on whether your production is artisanal or industrial, but on where your products go. Here is how to work out, in a few minutes, which regime applies to you.

What EC regulation 853/2004 says

Sanitary approval stems from the European “hygiene package”. Regulation (EC) no. 853/2004 lays down specific hygiene rules for foods of animal origin: meat, fishery products, milk and dairy products, eggs and egg products in particular. Its central principle: any establishment that prepares, processes, handles or stores such foods and places them on the market for other establishments must be approved by the competent authority before starting that activity.

In France, approval is issued by the département prefect after the file is reviewed by the DDPP (the département-level directorate for the protection of populations; DDETSPP in some départements). The approved establishment receives an approval number, displayed on its products inside the oval identification mark — the small “FR … CE” oval you see on packaging.

The system’s logic is preventive: when sensitive foods leave for other professionals, they can reach a very large number of end consumers; the State therefore checks premises, processes and the food-safety system before market placement, not after. Food-safety economists describe this choice as a classic answer to a market failure: consumers cannot observe a food’s safety at the moment of purchase. The analysis by S. Henson and J. Caswell, “Food safety regulation: an overview of contemporary issues”, published in 1999 in Food Policy, shows why governments favour these ex-ante controls on the riskiest links of the chain (see the study).

The decisive criterion: who are your customers?

Three regimes coexist, from lightest to most demanding.

Your situation	Regime	Formality
Direct sale to end consumers only	Simple declaration	Cerfa form no. 13984
Limited supply to other local retail shops	Exemption from approval	Declaration, cerfa form no. 13982
Supplying other businesses beyond those limits	Sanitary approval	Application, cerfa form no. 13983

The simple declaration covers classic food trades: restaurants, butchers, fishmongers, cheesemongers, neighbourhood caterers… as long as the clientele is exclusively the end consumer. These businesses must comply with general hygiene rules (and run a suitable PMS — plan de maîtrise sanitaire, the French sanitary control plan), but need no approval.

The exemption is an intermediate regime: it lets a retail business supply a marginal, local and restricted share of its own production to other retail shops — typically the baker supplying sandwiches to the grocery next door, or the butcher delivering to a few village restaurants. The weekly quantity caps and the distance limit (80 km as a rule) are detailed in our article on the exemption from sanitary approval.

Approval applies in every other business-to-business case: there is no “small” approval and no turnover-based tolerance outside the exemption’s limits.

Activities typically requiring approval

Whenever they supply other establishments, the following are classically covered:

• meat cutting and processing plants (charcuterie, cured meats, meat-based ready meals);
• fishery-product workshops (filleting, smoking, canning);
• dairies and cheese plants supplying resellers, affineurs or wholesalers;
• egg packing centres and egg-product manufacturers;
• central kitchens supplying satellite restaurants (schools, care facilities, company canteens);
• caterers working for professionals;
• temperature-controlled warehouses storing animal-origin foods for third parties.

Conversely, approval is not required for: businesses selling exclusively to end consumers, primary production (farming, fishing), which follows other rules, and activities handling only plant products.

A frequent special case: the farm producer. Selling your production at markets or at the farm is direct sale; starting to supply shops or restaurants brings you into the exemption’s scope, then into approval territory if volumes or distances exceed the limits. It is usually commercial growth — not a change in production — that triggers the obligation.

Mandatory means: before you start

The point that catches most entrepreneurs: approval is a prerequisite. The application (cerfa form no. 13983, with the establishment’s descriptive documents and the sanitary control plan) is filed with the DDPP before the activity begins. The assessment includes an inspection visit; the authorities may issue a conditional approval valid 3 months — renewable once, within a 6-month overall limit — while the establishment proves its system works. The full procedure is covered in our guide obtaining French sanitary approval: the DDPP file step by step.

Supplying professionals without approval or exemption exposes you to administrative measures (formal notice, even closure of the activity concerned) and immediately undermines the commercial relationship: most professional buyers — wholesalers, supermarkets, contract catering — check their suppliers’ approval numbers, since the list of approved establishments is public.

Do not confuse approval with other hygiene obligations

Approval replaces nothing: it comes on top of the common base. Every food business, approved or not, must comply with general hygiene rules and rely on a sanitary control plan built on HACCP principles — our page on HACCP and the French sanitary control plan covers these obligations. Likewise, the mandatory food-hygiene training in commercial catering is a separate scheme, which confers no right to supply professionals.

Remember the hierarchy: general hygiene for everyone → declaration for direct sale → exemption for marginal, local B2B → approval for B2B beyond that.

Take action

You now know whether your project falls under declaration, exemption or approval. For what comes next — the file, the sanitary control plan, the assessment, inspections — see our full page on Sanitary approval of food establishments: conditions, step-by-step procedure, FAQ and a free ebook to build a solid application.