What the New EU Regulation 2023/988 on General Product Safety Says
Starting on December 13, 2024, the new EU Regulation 2023/988 on General Product Safety will come into effect across all European Union member states, bringing significant changes to the sector. This regulation addresses the growing risks associated with online commerce and the sale of unsafe products in the EU.
What Does the New Regulation Entail and What Are Its Key Changes?
The EU Regulation 2023/988 repeals and replaces the Directive 2001/95/EC on General Product Safety, regulating the market entry of consumer products. It applies to all consumer products not already governed by specific regulations. Additionally, the regulation extends to products intended for industrial use, as long as the manufacturer can demonstrate the product’s safety and quality in the absence of specific regulations.
One of the most significant changes is the expansion of the definition of “safe product.” The regulation now includes criteria such as labeling, warnings, instructions for use, disposal, and cybersecurity features. It also requires that products display contact details for a Single Point of Contact so consumers can reach out to the market operator. Finally, the regulation treats online sales the same as physical sales, meaning online products must meet the same safety standards as those sold in brick-and-mortar stores.
Who is Affected by the New Regulation?
The following parties are impacted by the new regulation:
- Manufacturers
- Authorized representatives
- Importers
- Distributors
- Online marketplace providers
- Retailers
How to Ensure Compliance with EU Regulation 2023/988
To ensure compliance, businesses must follow several essential steps:
- Conduct a risk analysis.
- Prepare a technical file with any necessary attachments for risk analysis.
- Create a user and maintenance manual for the product.
Certification by a Notified Body is not required, but compliance with documentation and safety obligations is mandatory.
Products Included and Excluded from the Regulation
The EU Regulation 2023/988 applies to all products entering the European market, including new, used, repaired, or refurbished items, unless specific regulations apply. It also applies to consumer products already governed by EU legislation, if they do not address certain risks. However, there are specific exclusions, including products regulated by other sector-specific regulations:
- Human or veterinary medicines
- Food products
- Animal feed
- Live animals, plants, GMOs, and certain plant and animal products related to their reproduction
- Animal by-products and derivatives
- Pesticides
- Equipment used for transportation or travel that is directly managed by service providers
- Aircraft under Regulation (EU) 2018/1139
- Antiques
- Products clearly marked for repair or refurbishment before use
Opportunities for Manufacturers, Distributors, and Importers
Adhering to the new regulation offers several advantages:
- Increased consumer trust, enhancing the company’s image and market competitiveness.
- Easier access to EU markets, facilitating international expansion.
- Reduced legal risks, with a lower likelihood of sanctions or product recalls.
It is important to note that the European Commission has not yet published the GPSR Guide for businesses, but the regulation is already in effect.
Adapting to these new standards will help ensure safer products for consumers and enhance the competitiveness and reputation of businesses within the European market.
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