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.
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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 and online retail trends.
b. Maintain compatibility with changes to Union harmonisation legislation and standardisation legislation.
c. Improve the product safety recall 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the regulatory text, it will apply from 13 December 2024 – the date on which the GPSD and Directive 87/357/EEC will be repealed.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. Authorised representative d. Fulfilment service provider |
/ |
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 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, such as 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.
Examples
Here we list examples of products that are covered by the GPSR and for which harmonised standards exist:
- Child care articles (e.g., baby walking frames)
- Gymnastic equipment (e.g., asymmetric bars)
- Stationary training equipment (e.g., treadmills)
- Furniture (e.g., camping tables)
- Cycles (e.g., bicycles)
- Roller sports equipment (e.g., roller skates)
- Floating leisure articles for use on and in the water
- Paragliding equipment (e.g., emergency parachutes)
Note, however, that the GPSR covers consumer products in general, not only products for which harmonised standards exist.
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 sale. 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 (GPSR)
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 GPSR’s requirements.
According to Article 16 of the GPSR, covered products cannot be placed in the market unless there is an established economic operator in the EU.
This economic operator is responsible for carrying out several tasks, including some tasks set by the Market Surveillance Regulation. This includes, for example, cooperating with relevant authorities upon request.
In practice, this means that if you are a business selling to consumers in the EU but do not have an established EU entity, you must request the services of an authorised representative.
GPSR – Article 16
1. A product covered by this Regulation shall not be placed on the market unless there is an economic operator established in the Union who is responsible for the tasks set out in Article 4(3) of Regulation (EU) 2019/1020 in respect to that product. Article 4(2) and (3) of that Regulation shall apply to products covered by this Regulation. For the purposes of this Regulation, references to ‘Union harmonisation legislation’ and ‘applicable Union harmonisation legislation’ in Article 4(3) of that Regulation shall be read as ‘this Regulation’.
2. […] the economic operator referred to in paragraph 1 of this Article shall regularly check:
(a) that the product complies with the technical documentation referred to in Article 9(2) of this Regulation;
(b) that the product complies with the requirements provided for in Article 9(5), (6) and (7) of this Regulation. […]
3. The name, registered trade name or registered trade mark, and contact details, including the postal and electronic address, of the economic operator referred to in paragraph 1 shall be indicated on the product or on its packaging, the parcel or an accompanying document.
Market Surveillance Regulation (EU) 2019/1020 – Article 4(3)
3. Without prejudice to any obligations of economic operators under the applicable Union harmonisation legislation, the economic operator referred to in paragraph 1 shall perform the following tasks:
(a) if the Union harmonisation legislation applicable to the product provides for an EU declaration of conformity or declaration of performance and technical documentation, verifying that the EU declaration of conformity or declaration of performance and technical documentation have been drawn up […]
(b) further to a reasoned request from a market surveillance authority, providing that authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority;
(c) when having reason to believe that a product in question presents a risk, informing the market surveillance authorities thereof;
(d) cooperating with the market surveillance authorities, including following a reasoned request making sure that the immediate, necessary, corrective action is taken to remedy any case of non-compliance […]
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 that 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 person, who can carry out the product-related tasks established in Article 4(3) of the Market Surveillance Regulation, exists in the EU.
The responsible person, according to Article 4(2) of the Market Surveillance Regulation, can only be:
a. A manufacturer established in the EU
b. An importer, if the manufacturer is not established in the EU
c. An authorised representative
d. A fulfilment service provider established in the EU
In short, this means that companies that are not established, but sell their products, in the EU 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 – For example, 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 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 age, disability, or gender.
f. The product’s appearance, which might result in a usage not originally intended – For example, 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 protecting 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.
GPSR Harmonised standards
The GPSR comes with a long list of harmonised standards that set safety requirements for specific products. Products that follow harmonised standards are presumed to be safe.
Examples
Standard | Description |
EN 581-1:2006 | Outdoor furniture – Seating and tables for camping, domestic and contract use – Part 1: General safety requirements |
EN 716-1:2017+AC:2019 | Furniture – Children’s cots and folding cots for domestic use – Part 1: Safety requirements |
EN 913:1996 | Gymnastic equipment – General safety requirements and test methods |
EN 913:2008 | Gymnastic equipment – General safety requirements and test methods |
EN 913:2018 | Gymnastic equipment – General safety requirements and test methods |
EN 914:2008 | Gymnastic equipment – Parallel bars and combination asymmetric/parallel bars – Requirements and test methods including safety |
What if there are no harmonised standards for my product?
The lack of harmonised product standards under the GPSR does not exempt you from the safety requirements of this regulation. Instead, you need to look for the second best thing – which is non-harmonised European standards.
What if there are no EN standards for my product?
In the rather unlikely event that there are no EN standards at all to follow for your products, you need to either look for standards in other countries or markets or set your own safety criteria.
It’s also somewhat common to follow standards that are relevant to related products. For example, children’s watches likely do not fall within the scope of the Toy Safety Directive. That said, nothing prevents you from setting the bar high and applying EN 71, which is harmonised under the mentioned directive, when you design a children’s watch.
The bottom line of the General Product Safety Regulation must be safe, no matter what. Standards exist to help you get there for most products – but when they don’t, it’s up to you to define safety.
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 characteristics relevant for assessing product safety.
c. Product-specific risk analysis and adopted solutions for risk mitigation.
d. List of relevant European standards or other adopted measures (e.g., national standards, guidelines).
e. The outcome of relevant tests (e.g., test reports).
Instructions
Manufacturers must ensure that they provide, with their product, clear instructions and safety information that is written in an easily understandable language 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 including information concerning age suitability for children.
Placement
The GPSR requires manufacturers to place 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 take the form of a telephone number, an electronic 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, such as 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:
Amazon EU
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 also requires marketplaces to cooperate extensively with market surveillance authorities in EU member states.
Amazon will likely therefore become even stricter 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 the GPSR will likely make these requests more frequent, or perhaps make documentation and label submissions part of the default product listing process.
Amazon UK
The General Product Safety Regulation (GPSR) also impacts UK companies that are either selling to Amazon in the European Union, or to Northern Ireland.
Our understanding is that Amazon UK requires GPSR compliance for all Amazon sellers offering products in Northern Ireland, as it aligns with EU regulations.
That said, it is not clear to us if it is possible for Amazon sellers to opt out of selling to Northern Ireland or not.
Thanks for the great write up. I had trouble managing compliance for my Shopfiy store. I am now using a free app to be compliant and seems to be inline with your recommendations.
If anyone needs it: https://apps.shopify.com/gpsr
need update for GPSR
Main Differences Between The Authorized representative And The Manufacturer’s representative