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General Product Safety Regulation (EU) 2023/988

REGULATION (EU) 2023/988 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 10 May 2023 on general product safety was published in the Official Journal of the European Union on the 23 May 2023. The Regulation entered into force on 13 December 2024.

The GPSR regulation requires all products to be safe or pose only the minimum of risk in normal use and foreseeable use for the life time of the product. It does not replace product specific regulations, but applies to those products where safety aspects, risks and obligations are not covered in those specific regulations.

GPSR imposes obligations related to product safety on all businesses (Economic Operators (EO)) in the supply chain, according to their role, with those roles identified as:

Manufacturers,
Authorised representatives,
Importers,
Distributors,
Providers of online marketplaces.

These roles relate to the activities undertaken by the business so an individual business may fall into multiple categories.

In addition to the obligation to assure product is safe through risk assessment, the GPSR imposes specific obligations including; product marking, record keeping, cooperation with MSAs, reporting safety concerns, customer complaint handling, and corrective actions. Products covered by the GPSR coming from outside the EU must have a responsible person situated in the EU who must be able to discharge obligations for cooperation with the MSAs and regular compliance checks.

Assessment of Risk

Within the limits of their role EOs must assess the risk associated with product and its compliance, or ensure such assessments have been carried out and adequately documented.

Keeping Records

EOs must retain records, depending on the role in the supply chain of:

technical information relating to product - in particular product descriptions and risk assessments (for ten years)
the identity of the product supplier and to whom they distribute (for six years).

Marking of Product

The product must carry several specific pieces of information, easily visible and legible for consumers; allowing for practicalities this can be on a label, the packaging or on accompanying documentation as follows:

the name, address and website or email address at which the Manufacturer (or brand holder) can be contacted. AND

the name, address and website or email address at which the Importer can be contacted (if different)
the name, address and website or email address at which the Responsible person in the EU can be contacted (if not the Manufacturer or Importer)

a product identifier or reference number (readable by the consumer).
safety warnings - if the product presents a risk that might otherwise not be recognised by a consumer - and instructions for use and where appropriate, disposal,

Product identification needs to be sufficient to distinguish one product - should it present a risk - from otherwise similar products, allowing it to be traced through the supply chain and to the consumer.

Monitoring of Product Risk

Depending on their role EOs need to have procedures in place for monitoring product risk, both through the manufacturing process and after product has been placed on the market. The areas covered specifically include:

Production control measures to ensure product safety.
Risk proportionate sample testing.
Monitoring customer complaints, accidents etc and keeping of a register.
Maintenance of awareness of risks associated with similar products in the market .

Notification and Response to MSAs

If product is found to be unsafe EOs must notify the MSAs including all relevant technical information, corrective action taken and identify where they have made product available. They must also inform their suppliers and distributors.

When requested by MSAs EOs must provide the identity of suppliers and distributors; and this needs to be possible for a period of six years after the product has been received or placed on the market.

Procedures for Corrective Actions

EOs are required to immediately take corrective action if product is found to be unsafe or non conforming. Depending on their role this will require procedures for a company, to:

Adequately investigate the incident and the risk,
Make a regulatory notification (within 2 working days of completing the investigation), and in line with the severity of the risk, the most sustainable action resulting in the lowest environmental impact should be taken ie. to:

Withdraw product from the distribution chain - i.e. remove product from sale.
Recall product - i.e. get consumers to stop using and return product.
Take other appropriate action to remove the risk.

Note: When products are recalled, their value must be calculated on the basis of the initial purchase price paid by consumers.

Further information

Bolton Consultancy Ltd provides assistance in the requirements and procedures needed for compliance with product safety requirements in the UK, European Union and global markets. For further information on current product safety obligations or the proposed regulations please contact us.

< UK GPSR > Contact

The information contained in this note is believed to be accurate at the time of writing but is for information only and should not be relied upon. Reference should be made to the published standards or regulations.