Product Safety

A “safe product” is defined as a product which, under normal or reasonably foreseeable conditions of use—including its expected duration of use—does not present any risk, or only presents minimal risks that are considered acceptable and compatible with a high level of protection for the health and safety of consumers. Therefore, a product is considered safe when:

• it complies with applicable European or national safety standards;
• it takes into account the product’s characteristics, such as design, technical features, composition, packaging, and instructions for assembly, installation, use, and maintenance;
• it considers the effect of the product on other products (and vice versa), as well as its presentation, labelling (including age recommendations), warnings, and information for safe use and disposal;
• it assesses specific risks for vulnerable consumer groups—such as children, the elderly, and persons with disabilities—while also considering gender-related differences in health and safety;
• it considers the product’s appearance, particularly if it may lead to unintended use;
• it incorporates adequate cybersecurity features to protect the product against external interference (e.g. hacking attempts) that could compromise its safety;
• it takes into account any self-learning, evolving, or predictive functionalities that may affect the product’s behaviour over time.

It is important to note that the mere possibility of achieving a higher level of safety, or the availability of other products presenting a lower level of risk, is not sufficient to deem a product dangerous.

All economic operators placing or making products available on the EU market are required to comply with clear and strengthened obligations aimed at ensuring the safety of consumer products at every stage of their marketing, including through online trade.

Manufacturers

Manufacturers are primarily responsible for product safety and must:

• ensure that products are safe by design;
• carry out internal risk assessments and prepare the relevant technical documentation;
• take immediate action and notify consumers and national authorities through the Safety Business Gateway if they believe a product on the market is dangerous;
• share information about incidents;
• provide essential safety and traceability information on the product or its packaging;
• provide contact details for receiving complaints and keep an internal record of such complaints.

Manufacturers may appoint an authorised representative to fulfil their obligations.

Importers

Importers must:

• ensure that products comply with the general safety requirements of the Regulation, and reject any products they believe do not meet those standards;
• provide their contact details on the products and ensure they are accompanied by clear safety instructions and information;
• take responsibility for the products under their care during transport and storage;
• notify manufacturers and national market surveillance authorities via the Safety Business Gateway if they believe a product on the market is dangerous, and ensure the public is informed accordingly.

Distributors

Distributors are required to:

• ensure that manufacturers and, where applicable, importers comply with the requirements of the Regulation, and refuse to market any product they believe does not meet those standards;
• notify manufacturers, importers and national surveillance authorities via the Safety Business Gateway if they believe a product on the market is dangerous, and ensure that appropriate measures are taken.

Online marketplace providers

Online marketplace providers (operators that manage and offer digital spaces where manufacturers, sellers, and other economic operators can market their products) are obliged to:

• establish two single points of contact for direct communication on safety matters—one for market surveillance authorities and one for the public;
• register on the Safety Gate portal;
• implement internal product safety processes;
• ensure that no product listing can be published without minimum safety guarantees and traceability information provided by the responsible operator (compliance by design);
• conduct random checks on product safety using public databases, including the Safety Gate portal;
• respond promptly to government orders and third-party alerts, and ensure that listings of recalled products are not reposted;
• provide timely and appropriate information to consumers when a product is recalled, including contacting all affected buyers directly and publishing the relevant details on their website;
• notify the relevant economic operator and cooperate with market surveillance authorities in the event of a recall or incident.

Other economic operators

In addition to manufacturers, importers, distributors, and online providers, other actors involved in the distribution and sales chain must also comply with the obligations that apply to all economic operators, in order to ensure product safety. These obligations include, among others:

• implementing internal product safety processes to comply with the Regulation;
• cooperating with market surveillance authorities to eliminate or reduce risks from any product placed on the market;
• upon request by authorities, providing specific information about a product (risks, complaints, corrective actions) for ten years, and supply chain traceability information for six years;
• informing authorities of any incidents caused by a product;
• supplying data to a traceability system that the European Commission may establish to store details of products posing a serious risk to public health and safety;
• directly notifying all affected consumers about product recalls and safety warnings, using the mandatory recall notice template where applicable;
• offering consumers at least two of the following remedies in the event of a product recall: repair or replacement of the product, or an appropriate refund;
• complying with specific rules for distance selling by providing—already at the pre-contractual stage of the online offer—details of the manufacturer or authorised representative, a clear product description, and any warnings or safety information, as would be the case in a physical store.

It is important to know that for every product placed on the EU market, there must be an economic operator established within the EU who takes responsibility for its safety. This operator is tasked with ensuring that the product complies with the safety requirements set out in the regulation. Specifically, the responsible person for products placed on the market is required to:

• verify the product’s compliance, ensuring that it meets the technical documentation requirements established by the regulation and that it adheres to all relevant safety provisions. They are also required to carry out regular product safety checks and provide documented proof of these checks upon request by market surveillance authorities;
• monitor any potential risks associated with the product and take all necessary measures to minimise them. They must also ensure that the product continues to meet safety requirements throughout its entire lifecycle;
• indicate on the product or its packaging their name, registered trade name, brand, and contact details, including both postal and electronic addresses. This information must be easily accessible to both market surveillance authorities and consumers, ensuring product traceability throughout the supply chain.

The responsible person for products placed on the Union market plays a key role in ensuring that products are safe and compliant with EU regulations, allowing consumers to rely on the quality and safety of the items they purchase.

In the case of products that pose risks to the health and safety of consumers, it is essential to ensure a prompt and effective response. Economic operators must take immediate action once they become aware of a product placed on the market that represents a danger. In particular, the manufacturer is required to notify, via the Safety Business Gateway, any incident caused by the product, specifying the type, identification number, and, if known, the circumstances of the event. The notification must be sent without undue delay to the competent authorities of the Member State in which the incident occurred. Additionally, upon request, the manufacturer must provide the authorities with any further relevant information regarding the risk. Importers and distributors, in turn, are obligated to inform the manufacturer without delay if they become aware of an incident related to a product they have placed or made available on the market.

Product recall notice:

In the event of a product recall for safety reasons, or if certain information needs to be brought to the attention of consumers to ensure the safe use of a product, operators must ensure that all affected consumers are directly notified without undue delay through a recall notice. If not all affected consumers can be reached, economic operators must disseminate a clear and visible recall notice through other appropriate channels, ensuring the widest possible reach, including, if available: the company website, social media channels, newsletters, retail points of sale, and, where applicable, announcements in mass media and other communication channels. The information must be accessible to people with disabilities.

The recall notice must be available in the language(s) of the country where the product was sold and must have the title: “Product Safety Recall.” It must also include:

• a clear description of the product (including images, name, brand, serial or batch numbers, and details on where this information can be found, as well as information about the periods and locations of sale);
• a precise description of the risk, without downplaying the danger (expressions such as “precautionary,” “voluntary,” or “in rare situations” are prohibited);
• clear instructions for consumers to stop using the product immediately;
• details of the remedies available to consumers, such as repair, replacement, or refund;
• a free phone number or an interactive online service for assistance;
• an encouragement to share the information with others, if appropriate.

The European Commission, through implementing acts, establishes the recall notice template, taking into account scientific and market developments. This template is made available by the Commission in a format that allows economic operators to easily create a recall notice, including formats accessible to people with disabilities.

In the event of a product recall initiated by an economic operator or ordered by a competent national authority, the responsible economic operator must offer the consumer an effective, cost-free, and timely remedy. The economic operator must provide the consumer with the choice of at least two of the following remedies:

• repair of the recalled product;
• replacement of the recalled product with a safe product of the same type and at least of the same value and quality;
• an adequate refund of the value of the recalled product, provided that the refund amount is at least equal to the price paid by the consumer.

The economic operator may offer only one remedy if the others are impossible or would impose disproportionate costs, taking into account all circumstances, including the possibility of providing the alternative remedy without significant inconvenience to the consumer. The consumer always has the right to a refund if the economic operator has not completed the repair or replacement within a reasonable time and without significant inconvenience. Repair by the consumer is considered an effective remedy only if it can be carried out easily and safely, and if it is provided for in the recall notice. In such cases, the economic operator must provide the consumer with necessary instructions, free replacement parts, or software updates. The remedy must not cause significant inconvenience to the consumer, who should not bear shipping or product return costs. For non-portable products, the economic operator must arrange for the product to be collected from the consumer.

The authorities responsible for market surveillance in the Member States are tasked with ensuring that products comply with safety standards and taking corrective actions in case of non-compliance. To support this system, the Consumer Safety Network has been established as a cooperation platform between national authorities and the European Commission. This platform facilitates coordination, information exchange, and joint initiatives to address risks related to products on the market.

Safety Gate Rapid Alert System

The European Commission plays an active role in enhancing cooperation among Member States through advanced technological tools, including the Safety Gate (RAPEX), the EU’s rapid alert system for non-food dangerous products. This tool enables the immediate transmission of information between competent authorities regarding corrective actions taken, such as market withdrawals or recalls, thus ensuring a coordinated and effective response to protect consumer safety.

The Safety Gate portal is publicly accessible for free and provides constant updates on risks identified across various Member States. Its main function is to facilitate the timely sharing of information on products that pose a threat, particularly when there are serious health or safety risks. Each Member State has access to the system and must designate a national contact point responsible for managing notifications, ensuring their completeness and accuracy before forwarding them to the Commission. In Italy, the national contact point is established within the Ministry of Enterprises and Made in Italy, which coordinates the operation of the system at the national level. The Commission, in turn, verifies the compliance of the notifications received and forwards them to the other Member States. Notifications must be sent within four working days of the adoption of the corrective action, even in cases of less serious but still relevant risks. In addition to the mandatory information on the affected products and the actions taken, the system also allows the transmission of updates, changes, or revocations of previous measures. If a dangerous product has not yet been notified, the Commission can intervene by informing the Member States, which are required to verify the situation and take appropriate action.

Thus, the Safety Gate is an essential tool for the uniform protection of consumers across the Union. Thanks to its centralized structure and the timeliness of communications, it helps prevent the spread of risky products and strengthens consumer confidence in the European market. Additionally, the Commission is responsible for adopting delegated acts that define the operational procedures of the system, the criteria for risk assessment, and the requirements that notifications must meet.

Counterfeiting occurs when registered trademarks or distinctive signs are illegally applied to products by unauthorized parties, misleading consumers about the true origin, quality, or authenticity of the goods. It is a growing criminal phenomenon, now taking the form of a fully organized industry.

Counterfeiting affects a wide range of products and has severe consequences for the economy. It hampers the proper functioning of the internal market and poses a serious risk to consumer safety. Counterfeit products – particularly food, cosmetics, and pharmaceuticals – may contain dangerous or harmful substances, making them potentially harmful or even lethal. Additionally, consumers are often misled about the quality and origin of products, suffering economic damage and, in some cases, health risks.

Counterfeiting is a crime punishable under Article 473 of the Penal Code, which imposes penalties of up to three years in prison and fines for those who counterfeit or use counterfeit trademarks. At the European level, Regulation (EU) No. 608/2013 governs the protection of intellectual property rights by customs authorities, authorizing the seizure and blocking of goods suspected of violating these rights. Furthermore, in March 2024, the European Commission adopted the “EU Tool Box,” a recommendation that outlines a series of strategic measures aimed at combating both online and offline counterfeiting and improving the enforcement of intellectual property rights (IPRs). It promotes collaboration between rights holders, service providers, and law enforcement agencies.

How to protect against counterfeiting

• buy only from trusted sources: avoid unofficial markets, unauthorized sellers, and unverified online channels, which are often vehicles for the distribution of counterfeit products;
• do not buy products with an obviously low price: although it may seem like a bargain, it could be a product of inferior quality compared to the price asked;
• always check the product: pay attention to the quality of materials, the label, the packaging, and the presence of the original brand. Choose products in intact packaging with the manufacturer’s name visible and verify the origin and quality marks;
• carefully read the labels: the information on the packaging must be clear and truthful. Any inconsistencies could indicate a counterfeit product;
• report suspicious products: if in doubt, you can report the product to the relevant authorities, such as the Financial Police or the Local Health Authority (ASL).

If a product is identified that may pose a risk to health or safety, it can be reported to the National Contact Point, which is the Ministry of Enterprises and Made in Italy (MIMIT). It is advisable to provide as many details as possible, including: the product name and brand, identification code or model, description of the risk, place of purchase, and, if possible, photographs. The National Contact Point will assess the report and, if deemed substantiated, forward it to the European Commission, which may take the necessary measures to protect consumers, such as removing the product from the market. If the product was purchased from an economic operator based in another EU Member State and they do not respect consumer rights, the European Consumer Centre in your country can be contacted for assistance. Contact details are available on the ECC-Net website.