EU general product safety regulation

The GPSR replaced the General Product Safety Directive (GPSD), transitioning from a directive to a regulation. The Regulation is applicable in all EU Member States without the need for national transposition. It ensures uniform application of the rules across all Member States. 

The General Product Safety Regulation (GPSR), formally known as Regulation (EU) 2023/988, amends provisions in Regulation (EU) No 1025/2012 and Directive (EU) 2020/1828 of the European Parliament and the Council, and repeals Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC.

Main objectives under GPSR intend to:

  • Safeguard consumers by ensuring the safety of all products, including those with new technologies
  • Protect consumers in the growing online marketplace
  • Enhance market surveillance and enforcement to better protect consumers
  • Improve product recall procedures to minimize consumer risk

What you need to know

  • This Regulation is directly applicable and binding in all of the EU Member States.
  • This Regulation is an amendment of an existing Directive.  Although some aspects of this Regulation amendment are new, General Product Safety is not a new requirement in the EU.
  • The scope of application covers all aspects of the supply chain including Manufacturers, Authorized Representatives, Importers of cosmetic and general products in Europe, Distributors, Fulfilment Service Providers and Online Marketplace Providers.
  • For the cosmetics industry, common products that fall in the General Consumer Product category would include cosmetic products as well as items such as makeup tools, cosmetic bags, shower scrubbers, and other accessories that are not formulated cosmetic products.
  • To comply with the general safety requirement, a product must adhere to relevant harmonized European standards. This includes stricter labeling rules, requirements to prepare a technical file, carry out a pre-market risk assessment, and appoint a responsible person in the EU to handle specific tasks.
  • For all online sales, the manufacturer or Responsible Person (name, company name, postal and electronic address), product identification details, and any warning or safety information must be included on the online platform.
  • An EU-based company must be designated as the responsible person before a product can be placed on the EU market and those contact details for the local address and electronic information need to be on the labeling.
  • Manufacturers, and in certain cases Importers, are required to provide ways for consumers to report complaints or accidents. They will be required to investigate any complaints about product safety.
  • Manufacturers have an obligation to report any accidents related to products under GPSR. Where the manufacturer is not in the EU, the Responsible Person will ensure the reporting.
  • The GPSR requires that non-compliant products, accidents related to product use, or any product recall will be publicly disclosed and alerted through the new Safety Business Gateway system.

Timeline

Publication of the GPSR in the Official Journal of the EU.
The GPSR entered into force, marking the beginning of its implementation phase.
The transitional period ends, and the GPSR becomes fully applicable across the EU.

Impact

Brands have increased compliance obligations under this new regulations This includes:

  • more rigorous risk assessments
  • enhanced record-keeping
  • the need to adapt to new safety requirements 

Non-compliance may lead to enforcement actions.

Our expert advice

Ithos expert advice

We recommend brands conduct a thorough review of their products before introduction in the EU market as well as assess existing products to ensure they remain compliant with the new regulation.

Stay Compliant – Contact Ithos!

Our Regulatory Team can conduct a thorough due diligence of products for EU GPSR compliance.

Here are some important steps to consider:

  • Identify and review the current compliance of general consumer products in a portfolio
  • Examine product labels and website content for all relevant information
  • Define obligations for manufacturers, importers, and authorized representatives
  • Create SOPs, roles and responsibilities and processes for reporting in the Safety Business Gateway and throughout the supply chain
  • Review of product analytical, safety, and quality testing protocols for consumer products as well as the results and record keeping of such testing
  • Collecting, reviewing, and maintaining comprehensive documentation for all products offered within the EU
Reference links

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