PRODUCT SAFETY: NEW OBLIGATIONS FOR THE ECONOMIC OPERATORS

Consumer products placed or sold on the EU market, both through traditional stores or through means of distance or online sale, will be subject to stricter safety requirements starting with December 13, 2024, with the entry into force of the General Product Safety Regulation (GPSR).

The GPSR was published in the Official Journal of the EU on May 23, 2023 and is aimed at improving internal markets and ensuring a high level of consumer protection by reducing the number of dangerous products on the market.

Accordingly, under the new Regulation, a unique market monitoring regime will be applied in all EU Member States to all the products placed or made available on the market, be they new, second-hand, repaired or reconditioned.

However, it should be noted that only the products placed or made available on the market that are not regulated under other EU regulations fall under the GPSR.

If the products fall under specific safety requirements imposed by the Union law, the GPSR applies only to those aspects and risks which are not covered by such requirements.

Therefore, the following products do not fall under the scope of the RGPS:

• medicinal products for human or veterinary use;
• food;
• feed;
• living plants and animals, genetically modified organisms;
• animal by-products and derived products;
• equipment on which consumers ride or travel;
• aircrafts;
• antiques.

At the same time, the GPSR does not interfere with the Union law on consumer protection, which remains in force. Starting with December 13, 2024, the GPSR repeals the previous European legislative framework on general product safety, namely the Directives 87/357/CEE and 2001/95/CE, the latter transposed in Romania under the Law 245/2004 on the general product safety.

New obligations for the economic operators

The provisions of the new Regulation apply to economic operators and providers of online marketplaces but also to the provider of an intermediary service through an online interface allowing the customers to enter remotely into an agreement with the sellers to purchase products.

Thus, the Regulation provides for a set of specific obligations depending on the quality of the producer or the supplier putting up a product for sale.

Obligations of the manufacturers (selection)

• before placing a product on the market, manufacturers carry out an internal risk analysis and draw up a technical documentation (subject to periodic update), containing at least a general description of the product and its essential characteristics relevant for the assessment of its safety ;
• ensure that the product is provided with instructions and clear information on its safety; worded in a manner easily understandable by the consumers;
• use a type, batch or serial identification number for the product or other identification mark;
• Indicate on the product the name of the manufacturer and the contact address thereof;
• take measures to inform the economic operators, providers of online marketplaces in the supply chain, regarding any safety problem that the products could present;
• keeps a log of complaints, where is stored only the personal data necessary to investigate a potential complaint regarding an allegedly dangerous product; -
• in case of an accident caused by a product, the manufacturer informs without delay, through the "Safety Business Gateway" portal, the competent authorities of the Member State where the accident occurred.

Obligations of authorised representatives

Authorised representatives are vested, in written, by the manufacturer, to sell a product / products.

Authorised representatives shall:

• Provide, upon request, the market monitoring authorities any documentation about the product and any remedial measure taken, if appropriate;
• Informs the manufacturer when they have reasons to believe that a product is dangerous.

Obligations of the importers

• Importers are accountable for placing the products on the market;
• They undertake to affix on the product the name and the contact data, either on the packaging or on a document accompanying the product;
• Hold a register of customer complaints

Obligations of distributors:

• They shall ensure that remedial measures are taken to effectively guarantee product compliance, including withdrawal from the market and safety recall, as appropriate, and
• The ensure that market monitoring authorities of the member States where the product was placed on the market are informed right away on such issue through the “Safety Business Gateway”

Obligations of the appointed responsbile person

According to the Regulation, a products regulated thereunder cannot be introduced on the market unless there is an economic operator established in the Union who undertakes the responsibility for the safety of the said product. Such responsible person has mainly the obligation to:

• check compliance of the product with the technical documentation and with the identification and traceability requirements
• provide, upon request, to the market monitoring authorities, proof of having carried out all the checks regarding compliance of the product with the safety requirements

New obligations for online marketplace providers and remote sale

Specific obligations for remote sales

Where the economic operators place products on the market through means of remote sales, they have the obligation to indicate clearly and visibly the following information:

• the name, the registered commercial name or the brand of the manufacturer, the contact postal address and the email address - the name and the address of the responsible person established in the EU, as the case may be;
• information allowing product identification (the image or the type of the product);
• any warning or information relating to product safety, in a language easily comprehensible for the consumers.

Obligations of online marketplaces

• establish a unique contact point to facilitate the communication with both the monitoring authorities and the consumers.
• take voluntary steps to detect, identify, eliminate or block the access to content relating to offers of dangerous products on the market;
• process within 3 business days from receipt all notifications related to the safety of the products placed on the market;
• ensure availability of product safety internal processes, namely mechanisms to provide information about the manufacturer or about product self-certification;
• suspend service provision, for a reasonable term and after having issued a prior warning, to sellers who propose uncompliant products often;
• mandatorily informs both market monitoring authorities and the consumers with respect to dangerous products that were offered through their online platforms, notifying on the risks they pose to health and safety;
• remove the dangerous product from the online platform or display an explicit written warning within maximum two days since receiving the order of the market monitoring authority.

Requirements for assessment of product safety

When assessing product safety, both the economic operators and the online marketplace providers must consider some relevant aspects of the product, among which:

• product characteristics (technical characteristics, composition, packaging, assembling instructions, etc.);
• the effect on other products where it can be reasonably expected to be used with other products; interconnection of such products included; 
• the effect that other products might have on the product to be assessed;
• the presentation and labelling of the product; - the categories of consumers who are going to use the product;
• the external aspect of the product;

The regulation also provides for some supplementary elements to be considered, among which, international standards and agreements or compliance certification systems or national standards elaborated by certain Member States where the product is made available.

Therefore, all information about product safety must be presented in a clear and understandable manner for the customers.

Sanctions

According to the Regulation, Member States must provide by the date of enforcement thereof, which is December 13, 2024, the rules on the sanctions to be applied to economic operators failing to comply with this EU mandatory act. The sanctions must be effective, proportionate and with a discouraging effect.