The Official Journal of the European Union - OJEU, n. L 135, published the new Regulation (EU) 2023/988, relating to general product safety, which takes effect from 13 December 2024.
The new regulation is going to repeal the old directive 2001/95/EC, which had the necessity to be revised and updated in light of the developments related to new technologies and online selling of the last 20 years.
The objective of the new Regulation is to improve the functioning of the internal market, providing high level consumer protection which will make up for sector-specific legislations, which adress the safety aspects of specific products, but unable to cover all the relevant aspects. In fact, it is practically impossible to adopt law for all consumer products that exist or may be developed. There is therefore a need for a broad-based legislative framework of a horizontal nature to fill gaps.
Which products does the new regulation apply to?
This regulation applies to products placed on the market insofar, as there are no specific provisions governing the safety of the products with the same objective under Union law, following what has been already specified in the directive.
On the contrary, the products that are out of the scope of the regulation have been better defined, unlike in the old directive, which expressly mentioned only antiques. The product categories excluded from the scope of the regulation are:
- medicinal products for human or veterinary use;
- food;
- feed;
- living plants and animals, genetically modified organisms;
- 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 and is not operated by the consumers themselves;
- aircraft the operation of which involves low risk for aviation safety;
- antiques.
Distance sales
The old directive, entered into force over 20 years ago, was not designed to deal with distance sales as they are known nowadays. In fact, distance sales had only been mentioned once, in “whereas” section. Given the characteristics of a directive – legislative act that needs to be received by member states – the concept of distance sales was expressed in a cumbersome way. Therefore, the regulation – binding legislative act – plays a decisive role.
Article 4 deals with distance sales in a clear and unequivocal maner: «Products offered for sale online or through other means of distance sales shall be deemed to be made available on the market if the offer is targeted at consumers in the Union.»
Moreover, there is further explaination about the necessary information to be indicated in the case of distance sales, that lay under economic operators obligations.
Safety requirements
The common principle shared by the directive and regulation, is that economic operators place only safe products on the market. Product safety requirements are described in the regulation. In this regard, the points considered in evaluating the safety of a product are clearly outlined.
The most salient points are mentioned below:
- the technical features of the product, including its design, composition, packaging, instructions;
- the presentation of the product, the labelling, including the labelling regarding age suitability for children, any warnings and instructions for its safe use and disposal;
- the appearance of the product where it is likely to lead consumers to use the product in a way different to what it was designed for, 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 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 child appealing.
Manufacturers should draw up technical documentation regarding the products they place on the market, which should contain the necessary information to prove that those products are safe. The technical documentation should be based on an internal risk analysis carried out by the manufacturer.
RAPEX Safety Gate
One of the novelties that this regulation has introduced is the modernisation of RAPEX - Rapid Exchange of Information System.
As a matter of fact, if the directive has introduced the concept of rapid exchange of information between member states and the Commission regarding products that represent a risk concern, the regulation, on the other hand, aims to expand that concept and facilitates its use.
Therefore, it has been proposed a new name, Safety Gate, to enable greater clarity and to improve comunication towards consumers, in addition to a new internal partition that consists in:
- a rapid alert system on dangerous non-food products, Safety Gate;
- a web portal to inform the public and enable them to submit complaints, Safety Gate Portal;
- a web portal to enable businesses to comply with their obligation to inform authorities and consumers of dangerous products and accidents, Safety Business Gateway.
Recall notice
The economic operator shall offer the consumer the choice between at least two of the following remedies, in case that a product had been recalled:
- the repair of the recalled product;
- a replacement of the recalled product with a safe one of the same type and at least the same value and quality;
- an adequate refund of the value of the recalled product, provided that the amount of the refund shall be at least equal to the price paid by the consumer.