Conformity assessment according to GPSR

REGULATION (EU) 2023/988

Conformity assessment according to GPSR

Last June, a new regulation on consumer products, the General Product Safety Regulation (EU) 2023/988 (GPSR), entered into force. It applies to consumer products that are made available on the European market and which do not follow legislation harmonised across the European Union and /or specific safety requirements. The aim is to provide to European consumers with safe products.

This regulation, unlike the previous European legislation, the general product safety Directive (GPSD), outlines and defines which products are out of its scope, such as:

• Medicinal products for human or veterinary use;
• Food;
• Feed;
• Living plants and animals, genetically modified organisms, genetically modified microorganisms in contained use, and products of plants and animals relating directly to their future reproduction;
• Animal by-products and derived products;
• Plant protection products;
• Equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and which is not operated by the consumers themselves;
• Aircraft of Regulation (EU) 2018/1139;
• Antiques;
• Products to be repaired or reconditioned prior to being used where these products are placed or made available on the market and are clearly marked as such.

New technologies might pose new risks to consumer health and safety or change the nature of these risks. For this reason, the regulation defines particular aspects which must be taken into account when checking the safety of the product and introducing new aspects of risk assessment which are not focused on in the GPSD.

The relevant aspects for assessing the safety of products are as follows:

• Characteristics of the product (design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance);
• Effect on other products, including the interconnection of these products;
• Effect that other products might have on the product to be assessed;
• Presentation of the product (ex: labelling, warnings, instructions of use, etc.)
• Categories of consumers using the product (children, older people and persons with disabilities, as well as the impact of gender differences on health and safety);
• Appearance of the product and in particular:
• where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and might therefore be placed in the mouth, sucked or ingested by consumers, especially by children;
• where a product, although neither designed nor intended for use by children, is likely to be used by children or resembles an object commonly recognised as appealing to or intended for use by children because of its design, packaging or characteristics.
• Appropriate cybersecurity, if applicable;
• Evolving, learning and predictive functionalities of the product, if applicable.

According to the regulation, as in the previous directive, economic operators must assess the safety of products. The Regulation broadens the list of elements that must be taken into account during these assessments.

When assessing whether a product is safe, the following elements must be taken into account:

• European standards
• International standards
• International agreements
• Voluntary certification schemes or similar third-party conformity assessment frameworks
• Commission recommendations or guidelines on product safety assessment
• National standards drawn up in the Member State in which the product is made available
• The state of the art and technology, including the opinion of recognised scientific bodies and expert committees
• Product safety codes of good practice in force in the sector concerned
• Reasonable consumer expectations concerning safety
• Safety requirements adopted in accordance with Commission implementing acts.

The new Regulation shall apply from 13^th  December 2024.