From December 13, 2024, a new EU product safety regulation will apply. The new regulation contains obligations for the various economic operators. We give you an overview of the new manufacturer obligations.
The new Product Safety Regulation (Regulation (EU) 2023/988) will replace the existing Product Safety Directive. The new regulation will create a uniform framework throughout the EU and thus strengthen the internal market.
Until now, Member States have been able to adopt different provisions when transposing the Product Safety Directive into national law. However, the Regulation applies directly and therefore in the same way in all EU Member States.
SCOPE OF APPLICATION
The Regulation applies in principle to all products.
According to Art. 3 No. 1, a product is any article which is supplied or made available, whether separately or in combination with other articles, whether in return for payment or free of charge, including in the context of the provision of a service, and which is intended for consumers or is likely to be used by consumers under reasonably foreseeable conditions, even if it is not intended for them.
There are only exceptions for:
(a) medicinal products for human and veterinary use,
b) foodstuffs,
c) animal feed,
d) live plants and animals, genetically modified organisms and genetically modified microorganisms in contained
systems and products of plants and animals that are directly related to their future reproduction.
directly related to their future reproduction,
e) animal by-products and derived products,
f) plant protection products,
(g) means of transport which the consumer does not operate himself
(h) aircraft referred to in Article 2(3)(d) of Regulation (EU) 2018/1139,
i) antiques.
If there are specific safety requirements for products in Union law, the new Product Safety Regulation only applies to those aspects that are not covered by these specific requirements. This means that, in addition to the specific safety requirements, the obligations of this regulation also apply if it regulates other aspects or risks.
THE MANUFACTURER IN THE PRODUCT SAFETY REGULATION
The Regulation regulates the obligations of the individual economic operators.
Art. 3 No. 13 defines “economic operator” as the manufacturer, the authorized representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in connection with the manufacture of products or their making available on the market in accordance with this Regulation.
In Art. 3 No. 8, the Regulation defines a manufacturer as any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under his own name or trademark.
Art. 13 of the Product Safety Regulation then extends the circle of manufacturers even further:
- natural or legal persons who place a product on the market under their name or trademark
- natural or legal persons who substantially modify a product
This article will focus exclusively on the obligations of manufacturers. You can find an article on the obligations of retailers here at www.versandhandelsrecht.de (actual only in German).
GENERAL SAFETY REQUIREMENT
Art. 5 of the Product Safety Regulation generally stipulates that only safe products may be placed or made available on the market.
This general safety requirement is specified in more detail in Art. 7 and 8.
Art. 7 contains a presumption of conformity with the general safety requirement, while Art. 8 contains elements that must be taken into account when assessing the safety of products.
These include, for example
- other European standards
- international standards
- international agreements
- voluntary certification schemes
- Commission recommendations or guidelines
- national standards of the Member State in which the product is made available
- state of the art and technology
- codes of conduct
- safety that can reasonably be expected by consumers
- safety requirements laid down by the Commission in implementing acts
OBLIGATIONS OF THE MANUFACTURER
The obligations of manufacturers are regulated in Art. 9 of the Product Safety Regulation.
First of all, they are obliged to ensure that their products have been designed and manufactured in accordance with the general safety requirement set out in Art. 5.
To ensure this, manufacturers must – before placing their products on the market – carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and its essential characteristics relevant to the assessment of its safety (Art. 9 Para. 2).
CONTENT OF THE TECHNICAL DOCUMENTATION
The Regulation then specifies the content of this technical documentation “where appropriate in view of the risks that may be presented by the device”.
In this case, the technical documentation also includes
- an analysis of the risks potentially associated with the device and the solutions adopted to eliminate or reduce those risks, including the results of any reports of tests carried out by the manufacturer or by a third party, and
- a list of all relevant European standards referred to in Article 7(1)(a) and the other elements referred to in Article 7(1)(b) or Article 8 that have been applied to meet the general safety requirement referred to in Article 5.
Important: This technical documentation must be kept up to date and available for ten years after the product has been placed on the market and must be made available to the market surveillance authority on request.
For products manufactured in series, manufacturers must ensure that conformity with the general safety requirement is always guaranteed.
PRODUCT LABELING OBLIGATIONS
In addition to the general safety requirements, manufacturers must also label their products.
Manufacturers must ensure that their products bear a type, batch or serial number or another element that is easily recognizable and legible for consumers to identify them.
If this is not possible due to the size or nature of the product, this information must be indicated on the packaging or in a document accompanying the product (e.g. in instructions for use).
In addition, the name, the registered trade name or trademark, the postal address, an e-mail address and, if different, the postal address or e-mail address of the single point of contact must be indicated on the product itself. However, the following also applies in this respect: if this is not possible, it is sufficient to state this on the packaging or on a document enclosed with the product.
Manufacturers must also ensure that their product is accompanied by clear instructions and safety information in a language which is easily understood by consumers and which is determined by the Member State in which the product is made available on the market. This requirement does not apply if the product is safe even without this information. In Germany, this information must be provided in German.
BEHAVIOR WITH DANGEROUS PRODUCTS
If the manufacturer comes to the conclusion that the product he has placed on the market is a dangerous product, strict measures apply.
A “dangerous product” is any product that is not a safe product (Art. 3 No. 3).
A “safe product” is any product which, under normal or reasonably foreseeable conditions of use, including the actual duration of use, presents no or only minimal risks compatible with its use, which are deemed acceptable and compatible with a high level of protection for the health and safety of consumers (Art. 3 No. 2).
In this case, the manufacturer shall take the necessary corrective action to bring the product into conformity in an effective manner. This may also include a recall. He must also inform consumers and keep the market surveillance authority and other economic operators in the supply chain informed.
In order to inform consumers, the manufacturer may also use personal data of consumers that is available to him (Art. 35 (1)).
CONSUMER CONTACT DETAILS FOR SAFETY PURPOSES
If economic operators provide for a product registration system or customer loyalty programs, they must enable the consumer to provide separate contact details for security purposes only.
The personal data collected for this purpose shall be limited to the minimum necessary and shall only be used to contact consumers in the event of a recall or safety alert. No other e-mails, for example, may be sent to these contact details.
ESTABLISHMENT OF A COMPLAINTS OFFICE
Manufacturers must set up special complaints facilities. This must be done via publicly accessible communication channels (telephone, email, special section on the website). Consumers must be able to submit complaints and report information about accidents or safety problems that have occurred to the manufacturer (Art. 9 para. 11).
If such complaints are received, manufacturers must investigate them and keep an internal register of complaints. Product recalls and any corrective measures must also be documented in the register.
CONCLUSION
The new Product Safety Regulation contains numerous obligations for retailers. The member states still have to issue sanction regulations. There is currently a draft bill from the Federal Ministry of Labor and Social Affairs. This still has to go through the parliamentary procedure. Only then will it be possible to quantify the exact sanctions (such as fines).
