GENERAL PRODUCT SAFETY

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 Directive 87/357/EEC is repealed by the GPSR.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.

RECALLS

Summary

Notice

Economic operators including online marketplaces are legally obliged to use all available customer data to contact them directly on recalls and safety warnings.
The recall notice should clearly describe the risks, avoiding any expressions that may decrease or downplay the perception of the risk.
A product recall notice template will be made available by the Commission.

Remedies

Consumers should be offered at least two remedy options between repair, replacement, or refund of the recalled product. In addition, incentives to motivate consumers to participate in a recall, such as discounts or vouchers, should be encouraged. Product safety recall remedies should not cause any inconvenience for the consumers, nor place them at risk.

Sustainability

The most sustainable corrective action that is the one with the lowest environmental impact should be preferred, provided that it does not result in a lower level of safety.

3 Safety Gates

The Safety Gate Rapid Alert System (formerly RAPEX) exchanges information between authorities on recalls of dangerous products.
The Safety Gate Portal informs the public about dangerous products and also enables consumers to submit (serious) complaints.
The Safety Business Gateway enables businesses to inform market surveillance authorities about dangerous products and about accidents.

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.

MORE TOPICS

Summary

Market surveillance

Market surveillance should carry out joint activities, undercover online and offline shopping, and simultaneous ‘sweep’ actions.

Complaints

Manufacturers shall enable communication via telephone, e-mail or their website for consumers to file complaints and to inform about accidents or safety issues.
Manufacturers shall investigate and keep records of complaints, product recalls, and any corrective measures.

A Regulation

As opposed to a Directive, a Regulation does not give room for deviating transpositions of legislation by member states.

(EU) 2019/1020

The existing legal framework for market surveillance of ‘harmonised’ products as set out in Regulation (EU) 2019/1020 is now also applicable to ‘non-harmonised’ products covered by the GPSR. This is already the case in Germany.