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Criminal fines, strict liability claims, and a December 2026 deadline — what foreign manufacturers and distributors selling in Italy must fix now, and what each step costs
You manufacture a consumer product in the United States, Australia, or the United Kingdom. You sell it through a distributor or an online marketplace into Italy. A consumer is injured. Three months later, your Italian distributor forwards you a letter from a lawyer in Milan, a copy of a notice filed with the Italian market-surveillance authority, and a reference number from the EU Safety Gate rapid-alert system. You have no registered office in Italy. You do not have an Italian VAT number (partita IVA). You have never heard of the Italian Consumer Code.
This is not a hypothetical. It describes how a significant number of foreign-brand product-liability cases begin.
The short answer is this: under Italian law, strict liability falls on whoever placed the defective product on the market. The injured party does not need to prove fault. They prove the defect, the damage, and a causal link. That is all. And since May 2026, Italian authorities can add criminal sanctions on top.
Italy's product compliance framework is currently operating on three parallel tracks, and each one carries independent exposure.
The first track is Legislative Decree No. 78/2026, enacted on 15 May 2026 and in force since 16 May 2026. It amends the Italian Consumer Code (Legislative Decree No. 206/2005, the Codice del consumo) to align Italy's domestic product-safety enforcement with Regulation (EU) 2023/988 on general product safety (the GPSR). The GPSR had applied directly throughout the EU since December 2024, but this Decree now puts enforcement infrastructure in place: designated market-surveillance authorities, strengthened coordination with the EU Safety Gate rapid-alert system, and a revised sanctions regime.
The penalties are substantial. For placing a dangerous product on the market, the new Article 112 of the Italian Consumer Code imposes imprisonment from six months to one year and a criminal fine from EUR 10,000 to EUR 100,000, increased to EUR 150,000 where the product poses a serious risk. Failing to provide authorities with required information or obstructing checks carries an administrative penalty of EUR 4,000 to EUR 40,000. Breaching Chapter III obligations of the GPSR carries EUR 2,500 to EUR 25,000.
Sanctions now extend beyond manufacturers and distributors to other economic operators, including online marketplace providers. For a foreign brand selling through an Italian-hosted marketplace, that means the platform has a direct incentive to notify authorities and delist your product as soon as an alert is filed.
The second track is the incoming overhaul of defective-product liability itself. Italy's transposition process was initiated by Law No. 36 of 17 March 2026, which delegates the implementing decree to the Italian Government. The draft legislative decree is currently before the Chamber of Deputies. The decree was approved by the Council of Ministers in early August and has completed its committee passage; the Government may adopt the final text by 9 November 2026, a deadline extended by three months from the original August date. The new rules will apply only to products placed on the market after 9 December 2026; for those placed on the market before that date, current regulations remain in force.
The most immediate practical effect will be years of parallel regimes. Claims will continue to arise in relation to products placed on the market before 9 December 2026 under the old regime, while products placed on the market after that date will be governed by the new one.
Under the incoming rules, where the manufacturer is established outside the EU, the importer and the authorised representative are jointly liable; in the absence of both, the logistics service provider is liable. A non-EU manufacturer with no EU importer on record is therefore not invisible. It is merely shifting its exposure down the supply chain.
The third track is case law under the current Italian Consumer Code, which has continued to develop.
Unlike in most common-law jurisdictions — where a claimant must elect a cause of action and is generally bound by that election — Italian law allows an injured party to pursue product liability under the Italian Consumer Code and general tort law simultaneously, subject to one important limit. The Italian Court of Cassation, Third Civil Division, in Judgment No. 8224 of 28 March 2025 (Cass. civ., Sez. III, sent. 28 marzo 2025, n. 8224) clarified this precisely: the consumer must prove damage, a product defect, and the causal link under the Consumer Code regime; if a court then switches to Article 2050 of the Italian Civil Code, which governs liability for dangerous activities, a different burden structure applies — and mixing the two creates a reversible error of classification. The rules under the Consumer Code do not preclude an injured party from seeking protection under the other liability regimes provided by Articles 2043 and 2050 of the Italian Civil Code. In plain terms: a claimant's lawyer will choose whichever pathway has the lowest evidentiary hurdle on the facts. You cannot predict in advance which one that will be.
The incoming Directive (EU) 2024/2853 goes further still. It aims to mitigate the information asymmetry between consumers and manufacturers, especially with regard to AI systems, and introduces disclosure obligations and reversals of the burden of proof. The new rules seek to ease the burden of proof on claimants to prove defectiveness, particularly where the products relate to scientifically complex products, software, or AI-generated outputs.
Res ipsa loquitur — the thing speaks for itself — has long offered common-law courts a route to infer negligence from the fact of harm. The incoming Italian framework creates something structurally similar via presumption: once a claimant shows plausible harm consistent with a defect, the defendant bears the disclosure burden. The maxim is apt, but the mechanism is statutory, not judge-made.
The question every general counsel asks is: what is the budget? The answer depends on where the company starts from.
A baseline legal review — assessing whether your product documentation, traceability records, and distribution agreements comply with GPSR and the current Italian Consumer Code — will typically run EUR 4,000 to EUR 12,000 in legal fees for a single product category, assuming documentation exists and is accessible. This covers a review of the technical file, a check on whether your EU authorised representative appointment is legally effective, and a gap analysis against Article 112 as rewritten by Legislative Decree 78/2026. The review takes three to six weeks.
If the review reveals structural issues — no EU authorised representative, distribution agreements silent on recall obligations, inadequate traceability to batch level — remediation adds cost. Drafting or re-negotiating a distributor agreement for the Italian market: EUR 2,500 to EUR 6,000. Appointing an EU authorised representative and formalising their mandate in a form that passes Italian market-surveillance scrutiny: EUR 1,500 to EUR 3,500. These are one-off costs on a per-engagement basis; they are not recurring.
If a market-surveillance investigation is already open, or if the EU Safety Gate has published a notification relating to your product, you are in a different cost bracket. Responding to an Italian market-surveillance authority investigation, coordinating with the Ministry of Enterprise (Ministero delle Imprese e del Made in Italy, MIMIT), and if necessary contesting a recall order through the administrative courts typically requires EUR 15,000 to EUR 50,000 in legal fees, depending on complexity, the number of product lots affected, and whether criminal exposure under Article 112 is live. That range does not include the cost of the recall itself — logistics, replacement units, and consumer communications — which is commercially determined.
A civil product liability claim by an injured consumer before an Italian tribunal: court fees are modest (EUR 500 to EUR 2,000 in stamp duties and filing fees depending on the value of the claim), but defence costs and expert witness fees in a contested multi-year case regularly reach EUR 30,000 to EUR 80,000. Italian civil procedure moves slowly. A first-instance judgment in a major city such as Milan or Rome takes, on average, three to four years from filing.
The new Directive applies to products placed on the market or put into service after the transposition date, so the old regime continues to govern everything already on the market. That creates a dual-track position lasting years rather than months.
This creates a concrete board-level decision point. Products shipped to Italian distributors or consigned to fulfilment warehouses in Italy after 9 December 2026 will be governed by the new, stricter regime. Products already in stock or already placed on shelves before that date remain under the 1985-derived rules — until they generate a claim, which could happen years from now, under whichever applicable regime your legal team least prefers.
Under the incoming Italian framework, confidentiality measures currently available to defendants apply only to trade-secret and antitrust cases. Italian legislators will need to extend the existing framework or establish a separate regime for product liability claims. Until they do, the disclosure architecture for new claims remains uncertain. That uncertainty favours the claimant. In-house counsel and technical files that would be protected by legal privilege in a UK or US context enjoy no such protection in Italian product liability proceedings: legal privilege protection varies significantly across Member States and is generally less stringent than in the UK and US; in Italy, in-house counsel communications largely remain unprotected, even when they contain legal advice.
In our files, the most common mistake made by foreign manufacturers is treating the appointment of an EU authorised representative as a formality — a box-ticking exercise handled by a logistics provider. When a market-surveillance investigation opens, that appointment document is the first thing the Italian authority examines. If it does not explicitly grant the representative authority to receive official communications on the manufacturer's behalf, to cooperate with MIMIT, and to issue corrective measures, it is treated as legally ineffective. The company is then deemed to have no EU presence for enforcement purposes. The importer or logistics provider inherits the liability, initiates a claim against the manufacturer under the distribution contract, and costs escalate immediately. We see this sequence in roughly half the cases where a foreign brand first contacts the firm after an alert.
The current Italian Consumer Code rules, derived from Directive 85/374/EEC and consolidated in Legislative Decree No. 206/2005, apply to all products placed on the market before 9 December 2026, regardless of when the injury occurs. Strict liability attaches. The claimant proves defect, damage, and causal link; you bear the development-risk defence if you can establish it. The new Directive (EU) 2024/2853 does not apply retrospectively.
The criminal penalties under the revised Article 112 of the Italian Consumer Code, introduced by Legislative Decree 78/2026, target the "economic operator" who placed or made the product available on the Italian market. Where a foreign manufacturer has no Italian entity, prosecution focuses on the Italian importer or distributor. That entity will then seek indemnity against the manufacturer under the distribution contract or under general Italian contract law. The practical exposure for the foreign manufacturer is therefore financial and reputational, not directly penal — but the indemnity claim can be substantial.
Start with the EU authorised representative appointment document and your Italian distributor agreement. Verify that the representative mandate explicitly covers cooperation with Italian market-surveillance authorities. Check that the distributor agreement allocates recall costs, imposes notification obligations, and is governed by Italian law or includes a submission to Italian jurisdiction clause. These two documents determine your liability position in the first 72 hours of any investigation. Obtain qualified Italian law advice on both before shipping another consignment.
HREFLANG BLOCK:
Editorial Team — Panato Law Firm Staff
