General Product Safety Regulation: An Essential Guide

The General Product Safety Regulation (GPSR) is a new regulation that will replace the General Product Safety Directive (GPSD).  Its purpose is to set safety and other requirements for all consumer products, regardless of whether product specific regulations, directives, or standards exist.

This is already the case with the GPSD, but the GPSR goes beyond the GPSD in some aspects. The GPSR also provides more detailed requirements, for example in terms of product and packaging labelling.

In this guide, we help you better understand the new GPSR and the steps you must take before it finally replaces the GPSD.

What is the GPSR?

The General Product Safety Regulation (GPSR) aims to ensure the safety of products placed on the EU market and protect the health and safety of consumers, including children, the elderly, and people with disabilities.

It will replace the General Product Safety Directive (GPSD) which, according to the GPSR regulatory text, requires some changes to:

a. Take into consideration new technologies (e.g. software updates) and online retail trends.

b. Maintain compatibility with changes to Union harmonisation legislation and standardisation legislation.

c. Improve the product safety recalls system.

d. Provide a better framework for food-imitating products, which at the moment are regulated by Directive 87/357/EEC, which will also be replaced by the GPSR.

When will the GPSR apply?

The GPSR regulatory text was published in the Official Journal of the European Union on 23 May 2023, and it entered into force on 12 June 2023.

According to the regulatory text, it will apply from 13 December 2024 – the date on which the GPSD and Directive 87/357/EEC will be repealed.

How does the GPSR differ from the GPSD?

The table below outlines some of the main differences between the GPSR and the GPSD.

Requirement	GPSR	GPSD
Responsible person	a. Manufacturer b. Importer c. Distributor d. Authorised representative e. Fulfilment service provider f. Provider of an online marketplace g. An entity other than the manufacturer that considerably modifies the product	a. Manufacturer b. Distributor c. Importer d. Manufacturer’s representative
Labelling	a. Product type, batch, or serial number b. Manufacturer’s name, registered trade name or registered trade mark c. Manufacturer’s postal and electronic address d. Warnings (if applicable) e. Age suitability for children (if applicable)	a. Identity and details of the producer b. Product reference or batch number c. Warnings (if applicable)
Documentation	a. Technical documentation b. Instructions c. Test reports	a. Instructions b. Test reports
Communication channels	a. Telephone number b. Electronic address (e.g. an email address) c. A specific section of the manufacturer’s website	N/A
Lab testing	a. Generally required	a. Generally required

Which products are covered by the GPSR?

The GPSR covers products that:

a. Are meant for consumers.

b. Might be used by consumers even if they weren’t meant to be used by them.

c. Are new, used, repaired, or reconditioned.

The regulation applies to products placed on the market, so long as there aren’t any regulations that have the same objective as the GPSR to regulate the safety of the specific products in question.

For example, the Low Voltage Directive covers the electrical safety of electronic devices that operate with at least 50 V. Thus, the GPSR won’t cover electrical safety aspects of these products. However, it might cover other aspects (e.g. physical, or mechanical aspects).

Additionally, the GPSR might cover electrical safety for products that operate at low voltage (e.g., 12 Volts), and thus are not covered by the Low Voltage Directive.

Exempted products

Article 2 lists products that are not covered by the regulation. These are:

• Medicinal products (for human or veterinary usage)
• Food and feed
• Living animals and plants
• Genetically-modified organisms and microorganisms
• Plant and animal products related to their reproduction
• Animal by-products
• Products for plant protection
• Travel equipment operated by a service provider for consumers’ riding purposes
• Aircraft
• Antiques

Responsibility

The GPSR defines the various natural or legal entities responsible for engaging in activities related to a product’s manufacture and placement in the market. We explain them in this section.

Manufacturer

A “manufacturer” is defined as a person who:

a. Manufactures a product.

b. Has a product designed or manufactured under its name or trademark.

c. Markets its designed or manufactured product under its name or trademark.

Importer

An “importer” is defined as an established person in the EU who places a product on the EU market.

Distributor

A “distributor” is defined as a person in the supply chain, other than importers and manufacturers, who makes a product available on the market.

Authorised representative

An “authorised representative” is defined as an established person in the EU who receives instructions from a manufacturer and acts on said manufacturer’s behalf to complete specified tasks regarding the manufacturer’s requirements under the GPSR.

Fulfilment service provider

A “fulfilment service provider” is defined as a person who commercially offers at least two of the following services without owning the products involved:

• Warehousing
• Packaging
• Addressing
• Dispatching

These services do not include the following services, as defined in Article 3 of the regulation:

• Postal services
• Parcel delivery services
• Other postal services
• Freight transport services

Provider of an online marketplace

A “provider of an online marketplace” is defined as a provider of intermediary services who uses an online interface to permit consumers to conclude distance product sales with traders.

Note on companies not established in the EU

According to Article 16(1) of the GPSR, products covered by this regulation should not be sold unless a responsible economic operator, who can carry out the product-related tasks established in Article 4(3) of the Market Surveillance Regulation, exists in the EU.

In short, this means that companies not established in the EU but sell there will need an authorised representative, and affix the information concerning their authorised representation on their label.

Other obligations set by the Market Surveillance Regulation might also apply.

Safety Requirements

Article 5 of the GPSR mandates that “only” safe products are permitted for sale on the market.

Article 6 covers aspects that are relevant for assessing a product’s safety. Here, we list those aspects:

a. The product’s characteristics (e.g., composition, design, packaging, technical features, and instructions for assembly, installation, use, and maintenance).

b. How the product might affect other products, where the usage of the product with other products might be reasonably expected.

c. How other products (e.g., non-embedded products) might affect the product in question, where the usage of those other products is expected within reason.

d. The product’s labelling, information concerning age suitability for children, warnings, and instructions.

e. Risk assessment on how the product might affect different consumer categories, according to the age, disability, or gender.

f. The product’s appearance, which might result in a usage not originally intended (e.g., a non-foodstuff product might be confused with food and might result in ingestion by children).

g. When the product requires it, relevant cybersecurity features that protect the product from malicious third-party activity that might negatively impact the product’s safety.

h. The product’s evolving, learning, and predictive performance, if the product’s nature requires it.

Note that the possibility of achieving higher levels of safety, or the availability of other products that present a lesser degree of risk, should not be a reason to consider a product to be dangerous.

Standards

European standards for specific products may offer a presumption of conformity with the GPSR, meaning that products compliant with those standards might be assumed to conform to the regulation’s requirements.

If relevant standards do not exist, you could use other methods to ensure the safety of your product, as outlined below.

Presumption of conformity

Per Article 7, your product can be presumed to “be safe” if it complies with applicable European standards whose references are published in the EU Official Journal, where relevant risks or risk categories are concerned. Products are also presumably safe if, where relevant European standards don’t exist, the product complies with applicable national mandates regarding health and safety risks.

Note that even if your product is presumed to conform to the general safety requirement, market surveillance authorities may take action (e.g. recalls) if the product is evidently dangerous despite the presumption.

Additional ways to assess product safety

If no standard exists to offer a presumption of conformity with requirements set by the GPSR, you may utilise other routes of product safety assessment, such as those provided in Article 8. We list several alternate routes here:

a. European standards other than those for which the references are published in the EU Official Journal.

b. International standards.

c. International agreements.

d. Voluntary certification schemes.

e. Acceptable third-party conformity assessments.

f. Commission guidelines or recommendations for the assessment of product safety.

g. Product-specific EU Member State national standards.

h. Authoritative opinions of expert committees and recognised scientific bodies.

i. Codes of good practice regarding product safety.

j. Practicable consumer safety expectations.

European standards

As said, importers and manufacturers can use European standards whose references are published in the EU Official Journal to meet regulatory mandates, as those standards offer a presumption of conformity with requirements set by relevant directives or regulations.

However, it is not yet clear to us if standards previously referenced under the GPSD will also be referenced in the Official Journal of the EU under the GPSR, or if the list of standard will differ.

Documentation

Article 9 of the GPSR requires manufacturers to provide technical documentation and test reports as evidence of product safety before placing said products on the market. Manufacturers should also make sure that they provide consumers with clear user instructions for their products.

Technical documentation

Manufacturers should draft a set of technical documentation containing the following:

a. A general product description.

b. Essential product characteristics.

c. Product-specific risk analysis and adopted solutions for risk mitigation.

d. List of relevant European standards or other adopted measures (eg. national standards, guidelines).

e. The outcome of relevant tests (e.g. test reports).

Instructions

Manufacturers are required to ensure that they provide, with their product, instructions and safety information that is clear and written in a language that is easily understood and determined by the Member State where the product is sold.

Test reports

Manufacturers should include in their documentation the outcome regarding product tests carried out by themselves or another party on their behalf.

Labelling

The GPSR requires manufacturers to provide labelling information on their products and packaging, such as those relating to traceability and warnings. They should also adhere to requirements regarding the placement of such information.

Traceability information

Article 9 of the GPSR requires manufacturers to ensure their product’s traceability by providing product identification elements (e.g., batch, serial number, type). They should also provide their name (or registered trade name or registered trademark) and contact details (postal and email address).

Warnings and instructions

Manufacturers should provide relevant warnings and instructions regarding the product’s safe use and disposal. Additionally, information concerning age suitability for children might also be required.

Placement

The GPSR requires manufacturers to place the labelling information on their products. Manufacturers may, additionally, provide such information in a digital format on an electronic screen if their product has one.

When the size or nature of the product does not permit the placement of such information, manufacturers should instead put it on the packaging or in an accompanying document.

Communication channels

Article 9 of the GPSR mandates manufacturers to make communication channels that are available to the public and accessible for people with disabilities.

Those channels should permit consumers to submit complaints and inform the manufacturer of product safety issues.

The publicly-available communication channels can be in the form of a telephone number, an electronic address (e.g., an email address), or a specific section of the manufacturer’s website

Distance sales

Per Article 19, economic operators conducting online sales should clearly and visibly show the following information on their website:

a. The manufacturer’s name, registered trade name or trademark, and postal and electronic address.

b. The responsible person’s name and contact details, if the manufacturer does not have an EU address.

c. Product identifier (e.g., photograph, type, batch, description, serial number).

d. Warning or safety information.

Dangerous products

If a manufacturer reasonably believes, based on their information, that the product they placed on the EU market is dangerous, they are required to immediately:

a. Take corrective steps to ensure effective product conformity (e.g. product recall or removal).

b. Inform consumers via a product safety recall notice.

c. Use the Safety Business Gateway to inform market surveillance authorities about the product in question.

Lab testing

Article 5 requires that only safe products can be placed on the EU market. The most straightforward way to offer a presumption of conformity with the GPSR is to have your product tested against the requirements of relevant standards. These may or may not be referenced by the GPSD.

If your product passes testing, you receive a test report proving your product’s compliance with relevant standards or requirements.

As previously mentioned, the technical documentation you submit should include the outcome of any tests performed on your product.

Lab testing companies

As the GPSR has just come into force, most testing companies have not yet announced if they are capable of testing against the EU’s new GPSR.

As such, here are a few testing companies that claim to offer testing services against the GPSD:

• Eurofins
• Intertek
• SGS
• Element Labs
• F2 Labs

Amazon

The GPSR provides extensive requirements in terms of how marketplaces must ensure that products sold on their platforms are safe and fully compliant. The GPSR is also requires marketplaces to cooperate extensively with market surveillance authorities in EU member states.

It is likely that Amazon will therefore become even more strict when it comes to ensuring that products sold on Amazon Europe are fully compliant. In practice, Amazon sellers of essentially all types of consumer products can be requested to provide the following:

• Test reports
• Technical documentation
• Label photocopies

Another potential outcome is that all non-EU sellers must register with an Authorised Representative in the EU at some point.

Amazon is already making such requests, but it is  likely that the GPSR will make these requests more frequent – or perhaps make documentation and label submissions part of the default product listing process.