Product Safety

The special nature and technical nature of the subject matter requires a list of certain definitions that are useful for a better understanding of the topic.

Safe Product: means any product that under normal or reasonably foreseeable conditions of use, including duration, presents no risk or only minimal risks that are compatible with the use of the product and are considered acceptable in the context of a high level of protection for the health and safety of persons.

Hazardous Product: means any product that does not meet the definition of a safe product.

Serious Risk: Any serious risk, including those whose effects are not immediate, requiring rapid intervention by public authorities.

Manufacturer: the manufacturer of the product established in the European Community, and any other person claiming to be the manufacturer by placing its name, trade mark or other distinguishing mark on the product, or the person who reconditions the product. Manufacturers also include the manufacturer’s representative if the latter is not established in the European Union or, if no representative is established in the European Union, the importer of the product; other professionals in the marketing chain where their activity affects the safety properties of the products.

Distributor: means any professional in the marketing chain and whose business operations do not affect the safety characteristics of the products.

Recall: the measure aimed at obtaining the return of a hazardous product that the manufacturer or distributor has already supplied or made available to consumers.

Withdrawal: any measure aimed at preventing the distribution and display of a hazardous product, as well as its offer to Consumers.

According to the decree in force, a safe product is any product that under normal or reasonably foreseeable conditions of use, including duration and, where applicable, commissioning, installation and maintenance, does not present any hazard, or only presents minimal hazards, that are compatible with the use of the product and are considered acceptable under a high level of protection for the safety and health of persons, based on certain elements:

• product characteristics, including product composition, packaging, assembly and maintenance;
• the effects of the product on other products if they are used together;
• product presentation, labelling and instructions for use;
• the categories of consumers who are at risk when using the product, especially minors and the elderly.

Furthermore, the competent authorities must take the necessary measures to restrict the placing on the market or request the withdrawal or recall of the product if, despite compliance, it proves to be hazardous to the consumer’s health and safety.

If the parameters established by the legislator are not sufficient to automatically apply the above-mentioned regulations, mediation and interpretation by the relevant public authority will be resorted to on a case-by-case basis to establish compliance with product safety regulations or, after the damage has occurred, legal recourse to the competent judicial authority.

Product advertising is certainly an factor that can lead to a certain degree of consumer confidence in the product and can thereby affect the degree of safety that can legitimately be expected from it.

In addition to advertising, warnings also provide technical information about the product to minimise any risk a product might incur as a result of its particular hazard or use. Therefore, this information plays a major role in fulfilling the product safety requirement, although it can never compensate for the intrinsic technical defects of a given product.

Information/warnings must be characterised by the following requirements in order to adequately assist the consumer in the use of a particular product:

completeness: a concept equated with analytical character, according to which the instructions must clearly specify the hazard resulting from non-compliance;

evidence: consists in making the hazard easily understandable and identifiable to the consumer;

intensity: the instructions must make the consumer clearly understand the severity of the hazard to which he or she may be subjected.

According to their respective responsibilities, public administrations check that products placed on the market are safe.

The control system involves the competent Administrations taking measures proportionate to the severity of the product hazard, even after the product has been placed on the market. These control activities will be carried out through in-depth investigations, also consisting in the collection of product samples, to subject them to tests and analyses, and verify their safety.

In exercising the monitoring and control activities, the Public Administration may also establish special precautions for products with a high hazard potential, e.g. by providing for special warnings and/or the dissemination of information, when marketing the product. A marketing ban on the product may also be established, which may be permanent (or become so over time), or the manufacturer may be ordered to update products that have already been marketed, according to safety regulations, under penalty of withdrawal from the market or destruction.

The types of checks and measures that can be carried out and undertaken by administrations, depending on the level of product hazard, are for any product:

– provide, even after a product has been placed on the market as a safe product, for appropriate checks on its safety properties right up until the use or consumption phase, including by inspections at production and packaging plants, storage warehouses and sales warehouses;

– demand all necessary information from the parties concerned;

– take samples of products and have them tested and analysed for safety, drafting a report thereof, a copy of which must be given to the stakeholders;

for any product that may present hazards under certain conditions:

– require appropriate warnings about the risks it may present, drafted in a clear and easily understandable manner, to be affixed to the product in Italian;

– subject its marketing to prior conditions in order to make it safe;

for any product that may present hazards for certain individuals:

– provide that these persons be notified promptly and in an appropriate form of this hazard, including through the publication of specific notices;

for any product that may be hazardous:

– prohibiting the supply, offer to supply or display of the product for the time necessary to carry out controls, checks or safety assessments;

– order, within a fixed time limit, the adaptation of the product or a batch of products already marketed to the safety requirements of the legislative decree, if there is no imminent risk to public health and safety;

for any hazardous product:

– prohibit them from being marketed and take the necessary measures to ensure compliance with the prohibition

for any dangerous product already marketed, in respect of which the action already taken by manufacturers and distributors is unsatisfactory or insufficient:

– order or organise its effective and immediate withdrawal and inform consumers of the hazards presented by it. The related costs shall be borne by the manufacturer and, where this is not fully or partly possible, by the distributor;

– order or organise or, where appropriate, arrange with manufacturers and distributors, the recall of the product including from consumers and its destruction under appropriate conditions. The related costs shall be borne by the manufacturers and distributors.

For damage caused by a defect in a product (understood as any movable good, even if incorporated in another movable or non-movable good), the Consumer Code states the principle of absolute liability of the manufacturer, irrespective of fault (i.e. even if the manufacturer acted neither maliciously nor negligently during production).

 If the manufacturer cannot be identified, the supplier who distributed the product as part of a commercial operation is liable if the supplier failed to inform the injured party of the identity and domicile of the manufacturer or the person who supplied the product.

 The product is defective when it does not offer the safety that may legitimately be expected, taking into account all circumstances, including:

– the method of distribution, its presentation, its obvious characteristics, the instructions and warnings provided;

– the use for which it may reasonably be intended and the conduct which, in relation to the product, may reasonably be expected;

– the time the product was released.

Furthermore, the product is deemed defective if it fails to offer the safety normally offered by other products of the same type (excluding, of course, any misuse).

Finally, a product cannot be considered defective merely because another, more improved product was subsequently marketed.

The basic rule is that the manufacturer has to guarantee that safe products are marketed and must recall any products found to be defective and indemnify the injured parties.

There are 3 types of damage that can be caused by the defective product:

– death or bodily harm (e.g. a bottle containing a carbonated drink exploding in the consumer’s hands when opened);

– damage or destruction of a thing other than the defective product (e.g. defective varnish damaging a window covering material), provided that the product is normally intended for private use or consumption;

– damage to the product as a result of the defect in one or more of its parts (therefore, if the consumer also wants to be compensated for the damage suffered indirectly from the defective product, the consumer has to address the seller asserting the lack of conformity of the goods sold within the two-year period from delivery).

The law expressly (and exhaustively) provides for cases in which producer liability is excluded. It is specified that the manufacturer cannot be held liable if:

– it did not distribute the product;

– the defect did not exist when the distribution took place or subsequently emerged;

– the product was not manufactured to be sold or distributed for economic purposes or if it was not manufactured or distributed as part of a professional activity;

– scientific and technical knowledge during the period in which the product was released made it impossible to discover the existence of the defect;

– the defect is caused by the conformity of the product with mandatory rules or mandatory measures (as no punishment can be given for due conduct).

Furthermore, the manufacturer or supplier of a part forming the product (or of a raw material) cannot be liable if the defect is entirely due to the design of the product incorporating the part (or the raw material), or the instructions given by the manufacturer who then used them.

In such cases, liability therefore falls on the final manufacturer of the good, who is ultimately responsible for ensuring its marketing and who, therefore, should ultimately guarantee consumer safety.

The consumer who has suffered damage as a result of the defective product is entitled to compensation. Any agreement that excludes or limits in advance the manufacturer’s liability to the consumer is null and void. Compensation is not due when the injured party was aware of the defect in the product and the resulting hazard, and nevertheless voluntarily exposed themselves to it. The right to compensation is time-barred in 3 years from the day on which the injured party had or should have had knowledge of the damage, the defect and the identity of the liable party. Entitlement to compensation expires 10 years after the product that caused the damage was released on the market.

The burden of proof lies with the injured consumer, who must prove the causal connection between the defective product and the damage suffered; furthermore, the consumer must prove to the court that he or she used the product correctly.

Per giocattolo s’intende, ai fini della legge (D.Lgs. 54/2011), qualsiasi prodotto progettato o destinato, in modo esclusivo o meno, ad essere utilizzato per fini di gioco da bambini di età inferiore a 14 anni.

More and more frequently, counterfeit or non-compliant goods are being seized in Italy or at its borders. For this reason, careful attention must be taken when buying toys to prevent them from endangering children’s health.

Marking on products

When buying a toy, it is essential that the following is visibly, legibly and indelibly marked (on it or on the packaging):

1. the CE marking (dimension not less than 5 mm);
2. the name and/or company name and/or trade mark;
3. the address of the manufacturer or its representative or the person responsible for marketing the product in the European Union.

 Specifically, the CE marking is affixed to the toy by the manufacturer or its authorised representative in the European Union to attest, under its own responsibility, that the toy in question has been manufactured in accordance with European and national standards. This conformity is presumed since the certification is done through self-certification by the manufacturer. Sometimes, however, the presence of the CE marking is not sufficient to guarantee the safety of the toy, because the marking may often be falsified. Therefore, the marking must also be indelible, visible, legible and no smaller than 5 mm in size.

 These other safety marks may be found on toys:

1. the “Safe Toys” label of the Italian Toy Safety Institute;
2. the “IMQ” label of the Institute for the Quality Mark for Electrical Products.

These marks increase the guarantees that you are buying a sound product, since they indicate that the toys have undergone safety tests (electrical tests, flammability tests, chemical analyses, etc.).

RAPEX is the European rapid alert system for hazardous, non-food products. It enables the rapid exchange of information between the Member States and the European Commission on measures to be taken to prevent or restrict the circulation or use of products posing a health and safety risk to consumers – with the exception of foodstuffs, pharmaceutical products and medical devices, which are all covered by other mechanisms. Since 1 January 2010, the system makes it easier to rapidly exchange information on products that are hazardous to the health and safety of professionals and on products that pose a risk to the public interest.

– when a product is found to be hazardous, the competent national authority takes appropriate measures to eliminate the risk. It may recall the product from the market or issue warnings. The national contact point informs the European Commission (DG SANCO) about the product, its hazards and the measures taken by the authorities to prevent accidents.

– The European Commission disseminates the information received to the other national contact points and publishes weekly overviews of hazardous products and the measures taken to eliminate risks on the Internet.

– The national contact points ensure that the competent authorities in all Member States check whether the notified hazardous product is available in their territory. If so, the authorities take the necessary measures to eliminate the hazard, either by removing the product, recalling it or issuing warnings.

The list of national contact points can be found at this link

The term “food safety” is understood to mean compliance – at all manufacturing, processing and distribution phases – with hygiene requirements to ensure the wholesomeness of foodstuffs and thus the absence of contamination that could expose consumers to the risk of food poisoning. 

Food safety is regulated by a series of specific European and national regulations that affect the entire supply chain, from manufacturing to marketing and administration of food and beverages, including official control and emergency management. Specifically, Regulation (EC) No 178/2002, which is a true ‘framework law’ on the subject, outlines the general principles and requirements of a new food law, establishing the European Food Safety Agency (EFSA) and defining food safety procedures.

One of the main innovations of the regulation consists in imposing on the food industry the “traceability” of foodstuffs during all stages of the production chain. In case of an emergency, this measure allows specific batches of products to be recalled from the market, thus avoiding more drastic and unnecessarily destructive interventions.

Regulation 178/2002 is also credited with the creation of a “Rapid Alert System for Food and Feed” (RASFF), set up to provide an effective means of exchanging information on measures taken in response to the identification of a hazard related to food or feed to all food or feed control authorities in various countries. 

If problems with the hygiene of the premises or staff, or in any other way that could compromise food safety, are detected in a sales or catering establishment, the parties responsible should be notified immediately and, if necessary, the competent local health authority should be alerted.

Counterfeiting is a very old and common phenomenon that is now increasingly becoming a real criminal industry, with serious repercussions in both the economic and social spheres, which has a significant impact on the proper functioning of the internal market and consumer safety.

Counterfeiting occurs when distinctive signs or trade marks already registered and attributed to certain products are affixed by unauthorised third parties to new, or merely similar, products, or even products that differ from those lawfully marketed by the trade mark owner in question.

Counterfeiting also occurs when consumers are misled about the real origin of products.

This is a real offence, punished by Article 473 of the Criminal Code, which reads as follows: “Anyone who counterfeits or alters national or foreign trade marks or distinctive signs of original works or industrial products, or who, without having taken part in the counterfeiting or alteration, makes use of these counterfeit or altered trade marks or signs, is liable to imprisonment for up to three years and a fine of up to four million lire. […]”.

To combat counterfeiting, the European Union enacted Regulation 1383/2003 and Regulation 1891/2004 that allow customs authorities to intervene in customs areas to stop all shipments – whether import, export or transit – suspected of infringing intellectual property rights.

According to Regulation 1383/2003, counterfeit goods are defined as:

1. a) goods, including their packaging, to which a trade mark identical to a trade mark validly applied or registered for the same types of goods has been affixed without authorisation, or that cannot be distinctively differentiated from that trade mark from its essential aspects, and which thereby violates the rights of the trade mark holder;
2. b) any distinctive sign (including logo, label, sticker, brochure, leaflet or guarantee document containing such a sign), even if presented separately, having the same character as the goods referred to in a);
3. c) packagings bearing the marks of the counterfeit goods presented separately, which are in the same situation as the goods referred to in a).

Today, counterfeiting is a flourishing business that is no longer limited to the world of clothing, but affects several economic sectors.

It is worth remembering that the dangers of fakes also apply to toys, medicines, foodstuffs and spare parts: buying one of these counterfeit products can cause damage to your health!

When we buy a counterfeit garment or accessory, we often do not appreciate the risks we are running. Clothes and underwear are made from harmful materials or substances that can cause allergies when worn. Counterfeit glasses can seriously damage your eyesight. Therefore, it is better to rely only on originals.

Counterfeit food products pose a serious health hazard. The ingredients used are of dubious origin, do not meet safety standards, and their processing is the result of unlawful manufacturing processes using substances that are hazardous to health. The most elementary rules concerning the expiry date of the ingredients used are completely disregarded.

If we give a counterfeit toy as a present, we are harming our children, because it is made of toxic or flammable materials, with no regard for safety regulations; it is easily worn out and can shed fragments, thus becoming even more hazardous.

Counterfeit cosmetics can contain high percentages of heavy metals, such as mercury and lead, which are extremely harmful to our skin. In order to be placed on the market, cosmetics must meet very strict selective criteria, pass rigorous protocols and tests and use specific, safe ingredients. Buying a counterfeit cosmetic undermines the safety that comes from an established and qualified production chain

Counterfeit car parts put the driver’s life at risk and damage the vehicle. Similarly, electronic equipment, which must meet precise standards in order to be marketed, can turn into real hazards in our homes if counterfeited.

– do not buy products with a manifestly excessively low price: it may seem like a bargain; however, you are buying a product that is worth much less than what it costs;

– do not buy products from unauthorised sellers;

– only buy safe products in unopened packaging with the manufacturer’s name. Ensure the origin and any quality marks;

– read labels carefully;

– always remember that if you buy a fake product you risk an imposition of an administrative penalty, i.e. a fine of 100 to 7000 euro.