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New Rules on General Product Safety

Many directives and regulations address product compliance worldwide. Yet it is still practically impossible to cover all risks for all consumer products. The solution in this article is a broad-based legislation to fill possible gaps and to complement existing and future legislation.

This “one for all” solution is provided by the current General Product Safety Directive and its successor the General Product Safety Regulation (GPSR). It provides a ‘safety net’ to ensure a high level of protection of safety and health of consumers.

On 23 May 2023, the General Product Safety Directive (GPSD) 2001/95/EC has been replaced with the General Product Safety Regulation (GPSR) (EU) 2023/988.

The transition period ends 13 December 2024.

GPSR Summary

Below is a non-exhaustive summary of topics covered by the GPSR, in a random sequence:

RISKS

Summary

Health

Health is defined as complete physical, mental and social well-being and not just merely the absence of disease or illness. Assessment of mental health of especially children using connected products is required.

Assessment

Manufacturers shall carry out an internal risk analysis and draw up a technical file.
Attention to the most vulnerable consumers, such as children and older persons remains essential and is extended with risks for persons with disabilities.
The aspects for the safety assessment have been extended with risks of emerging technologies such as cybersecurity (hacking, privacy), artificial intelligence (predictive, learning products), robotics, and 3D printed articles.

Design

The GPSR emphasises that a high level of safety should be primarily be achieved by design and products should “not present any risk”. The non-avoidable remaining risks should be addressed with warnings and instructions.

Processes

It is compulsory for economic operators to have internal processes for product safety. Procedures should be present to make sure that products produced in series remain in conformity.

Food imitations

Non-food products that are likely to be confused with foodstuff should be considered dangerous. Directive 87/357/EEC is repealed by the GPSR.

Chemicals

A safety net for chemical risks in products not covered by specific legislation. This includes environmental risks as much as safety and health of consumers.

Software

Software updates, including Over The Air (OAT), that ‘substantially’ modify the original product shall be submitted to a new risk analysis.

Check the product quality against the criteria listed under the updated EU GPSR.

TRACEABILITY

Summary

Identification

Products shall bear identification such as a type, batch or serial number.
Name, postal 
and electronic address of the manufacturer shall be placed on the product.
In the case non-EU manufacturers contact information shall also be provided about the EU-based ‘Responsible Person’.
Any economic operator shall keep information about who has supplied them with the product (part, component, software) and to whom they have supplied the product.

Responsible Person

A product may be placed on the market only if there is a Responsible Person (an economic operator) established in the EU. The name, postal and electronic address, of the responsible person shall be indicated on the product or on its packaging.
The Responsible Person shall regularly check the compliance with the technical documentation, product and manufacturer information, instruction and safety information.
Evidence of the regular checks shall be documented.

Online sales

Webshops, online markets or distance sales shall clearly display the following information about the products offered: name and contact details of the manufacturer; name and details of the EU responsible person; identification of the product, including a picture of it; and any warning or safety information in a language easily understood by consumers.

Economic operators

In addition to manufacturers, authorised representatives, importers and distributors the GPSR identifies fulfilment service providers, and providers of an online marketplace.

For more details, please refer to the article originally published by ProductIP.

Picture of Caspar ter Horst – Managing Director, ProductIP

Caspar ter Horst – Managing Director, ProductIP

Casper has 25+ years of experience in product compliance. In 2008, he co-founded ProductIP together with Maarten van der Dussen. Caspar and his team are dedicated to support companies within the supply chain to efficiently demonstrate to customers, authorities, and users that their products meet applicable legislation and buying requirements. As a result, helping companies reduce costs, streamline operations, manage suppliers, and at the same time put compliant, safer, more sustainable products to the market.

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