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What manufacturers, importers and distributors selling in Italy face under Legislative Decree 78/2026 — sanctions, recall mechanics, authority powers and the compliance bill before the first enforcement action arrives
More than 4,700 dangerous-product alerts were processed through the EU Safety Gate rapid-alert system in 2025 — up 13% and the highest on record, with a 35% rise in follow-up actions, including withdrawals, recalls, border stops and marketplace delistings, and more than 1,200 online marketplaces registered on the Safety Gate Portal by the end of 2025. Italy is one of the most active submitting states. If your product appears in a Safety Gate alert linked to the Italian market, the first obligation — notifying the competent authority — arises immediately, with no grace period and no minimum risk threshold that must be crossed before you must act.
That was the legal picture before May 2026. Since then, the calculus shifted materially for every company selling consumer products in Italy. Italy closed the last gap in its enforcement architecture and the personal stakes for company officers rose sharply.
The Italian penalty framework for Regulation (EU) 2023/988 on general product safety is now defined by Italian Legislative Decree 8 April 2026, No. 78, published in the Italian Official Gazette No. 111 of 15 May 2026 and in force since 16 May 2026.
The Decree, enacted on May 15, 2026, amends the Italian Consumer Code to align Italy's domestic product-safety enforcement framework with Regulation (EU) 2023/988 on general product safety. While the GPSR has applied directly throughout the European Union since 13 December 2024, the Decree establishes the mechanisms of national coordination, market surveillance and sanctions underpinning GPSR application in Italy.
That distinction matters. The GPSR itself — the new European General Product Safety Regulation (Regulation (EU) 2023/988), which in May 2023 replaced the earlier 2001 directive (2001/95/EC) — is self-executing across the EU. But the penalties for violating it are set at national level, and Italy's were, until May 2026, incomplete. The Decree fixes that.
The decree amends the Italian Consumer Code and replaces Article 112, introducing criminal and administrative penalties for economic operators that place or make dangerous products available on the market, fail to cooperate with the authorities, or breach GPSR obligations.
Decision-makers routinely underestimate the bill. The regulatory fine is only one line item.
Criminal and administrative fines. The most relevant penalty concerns dangerous products: imprisonment from six months to one year and a fine from EUR 10,000 to EUR 100,000, increased up to EUR 150,000 where the product presents a serious risk, under Article 112(1) of the Italian Consumer Code, as replaced by Legislative Decree 78/2026. These are criminal-law figures, meaning the company's legal representative — often the CEO or country manager — is personally exposed, not just the entity.
Sanctions for violations of product-safety obligations now extend beyond manufacturers and distributors to other economic operators, including online marketplace providers. Furthermore, criminal sanctions may apply for dangerous products, while administrative penalties cover GPSR breaches, failures to cooperate with authorities, and breaches of market-surveillance measures.
Recall logistics. A recall of 5,000 units costs EUR 30,000 to EUR 50,000 in logistics alone — before legal fees, rebranding or replacement production. Apply that to a mid-size Italian distribution network of 50,000 units and the logistics figure alone reaches EUR 300,000 to EUR 500,000 (approximate range based on pro-rata industry data). Consumer remedies add further to this figure.
Consumer remedies. Consumers affected by a recall are entitled to an effective, cost-free and timely remedy. The GPSR requires that consumers be offered at least two options from the following: repair, replacement or refund. If the repair or replacement is not completed within a reasonable time, the consumer is entitled to a refund.
Notification obligations. Under the GPSR (Regulation (EU) 2023/988), the operator informs the market surveillance authorities immediately through the Safety Business Gateway; an accident is notified without undue delay from the moment the manufacturer knows of it (Article 20(1)). The authority then submits the Safety Gate alert within four working days of the corrective measure (Article 26(4)). (sentence cut off — complete or remove)w compounds the sanction exposure.
Unlike most common-law markets, where a single national regulator or trading standards body typically owns product safety enforcement, Italy operates a multi-authority model that surprises most foreign operators. In the United Kingdom, for instance, the Office for Product Safety and Standards (OPSS) serves as the lead national authority with consolidated powers. In the United States, the Consumer Product Safety Commission (CPSC) holds primary jurisdiction for most consumer goods. In Italy, authority is divided by sector and by function, and several bodies may act simultaneously on the same incident.
The functions of the supervisory authorities are performed by the Ministry of Enterprises and Made in Italy (MIMIT) and the Ministry of Labour and Social Policies, according to their respective competencies. MIMIT (the Ministero delle Imprese e del Made in Italy) leads on general consumer product safety and is the primary contact point under the GPSR. The Ministry of Health (Ministero della Salute) covers food, pharmaceuticals and medical devices. The Carabinieri NAS (the health and food-fraud unit of the Carabinieri military police) conducts unannounced physical inspections. The Guardia di Finanza covers customs and import controls. The AGCM — Italy's competition and consumer authority — can act on misleading product claims. The supervisory authorities, including Customs, the Chambers of Commerce (CCIAA) and AGCM, carry out inspections on all imported products, based on existing control systems, to verify compliance with the regulation.
The practical consequence: an incident with a product on the Italian market can trigger parallel investigations by two or three different bodies at once. Each may issue its own corrective-action order. Coordinating responses across multiple authorities while managing a live recall is where foreign companies consistently lose time and money.
The compliance cost is not purely regulatory. On 24 July 2026, Italy's Court of Cassation issued a landmark order in consumer litigation regarding cell phone radiation and health. The Court held that complying with technical standards does not, by itself, relieve a manufacturer of its duties to consumers. That is Italian Court of Cassation order of 24 July 2026 in Briganti v. Apple (Cass., ord. 24 luglio 2026).
Cell phone makers must do more than meet RF radiation limits; they must also clearly inform users how the phone should be used to remain within those limits and adequately inform consumers about potential health risks and precautions, so they can make informed decisions about how they use the device.
The principle — that regulatory compliance is a floor, not a ceiling — is not new in Italian case law, but this ruling applies it directly in a product-safety consumer context and signals a markedly activist posture by the Italian Court of Cassation. For a foreign manufacturer entering Italy, this means that conformité to an EU harmonised standard does not extinguish the duty to warn and the duty to monitor in use.
The Italian Supreme Court, Third Civil Division, reached a parallel conclusion in Judgment No. 8224 of 28 March 2025 (Cass. civ., Sez. III, sent. 28 marzo 2025 n. 8224): the Third Civil Division reaffirmed that the manufacturer's liability for defective products, although detached from any finding of fault, is presumed liability in nature — not strict liability in the proper sense — and that in order to be relieved of it, the manufacturer must show that the defect giving rise to the damage did not exist at the time of placing on the market.
The two rulings together compress the manufacturer's exit routes. Proving standard compliance buys less protection than it used to. Proving no defect at the point of supply is the threshold that matters.
One more layer arrives before the year is out. Member States must transpose the new Product Liability Directive by 9 December 2026: from that date the new rules will apply to products placed on the market or put into service after that deadline, while products placed on the market before 9 December 2026 will continue to be governed, on a transitional basis, by the old 1985 regime.
The new Directive (EU) 2024/2853 on product liability significantly expands the definition of defect, reverses the burden of proof in certain circumstances, and extends liability to software and digital content. Any company entering Italy or extending its Italian distribution in the coming months is placing products under the incoming regime. The compliance document set — technical files, risk assessments, safety instructions, recall procedures — must be built to the new standard, not the old one.
Nemo ignorantia iuris excusatur — no one is excused by ignorance of the law. A gloss worth keeping: Italian courts apply this principle to foreign companies operating in Italy precisely as they do to domestic ones. Saying you did not know about D.Lgs. 78/2026 is not a mitigating factor before MIMIT.
As the legal theorist Guido Calabresi observed in The Costs of Accidents (1970), the allocation of accident costs between an injurer and society is always a policy choice — and Italy's current legislative direction is unambiguous: more cost on the economic operator, less on the consumer and the state. That direction accelerates with the December 2026 deadline.
In our files, the most common mistake is treating the Safety Business Gateway notification as the end of the obligation, not the beginning. Companies file the initial alert, then fail to implement the corrective action or fail to document that they contacted every identifiable buyer. MIMIT's market-surveillance inspectors check both the filing date and the follow-through. A notification without a documented recall plan — written in Italian, addressed to all Italian distributors, with a consumer-facing remedy mechanism — will be treated as non-compliance with the corrective-action obligation, not as partial compliance.
Yes. Italian language requirements apply to warnings, safety information, recall notices and consumer safety information under D.Lgs. 78/2026. Selling through an online marketplace does not exempt you: the marketplace itself now has GPSR obligations, but those are parallel to, not a substitute for, your own notification duties as manufacturer or importer.
The manufacturer or distributor that discovers a defective product is obliged, irrespective of a request from the authority, to immediately inform it of the risks relating to products they place on the market and that are incompatible with the safety requirements, indicating the action taken or to be taken to avoid those risks. In practice, the notification is filed through the Safety Business Gateway by the EU Responsible Person — a mandatory role under the GPSR. If that person provides incomplete information, personal criminal liability may follow under Article 112 of the Italian Consumer Code, as amended by D.Lgs. 78/2026. The EU Responsible Person must be established in the EU; a non-EU manufacturer without one is treated as the operator in default for every penalty purpose.
There is no statutory maximum, but MIMIT will monitor progress. A voluntary recall for a contained risk — say, a single lot of a product sold through two or three distribution channels — typically runs 60 to 120 days from the initial notification to documented completion. A recall involving mass retail distribution across Italy (20 regions, thousands of retail points) runs six to twelve months. The distributor is required to maintain and provide the authority with appropriate documentation to trace the origin of the products for a period of 10 years from the date of transfer to the final consumer. The recall file must be retained for that period and must be producible on demand.
HREFLANG BLOCK:
Editorial Team — Panato Law Firm Staff
