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In addition to Member States, the EU single market includes Norway, Iceland and Liechtenstein. To facilitate the free movement of goods, common rules apply to products in all of these countries. Member States enact their own safety regulations for services. As a business owner, you are responsible for ensuring that the goods and/or services you sell are safe. You need to find out which legislation applies to you and ensure that you meet statutory requirements.
Translated page: This text has been translated from Swedish. The text and appearance of the page may look different from the original page.
What legislation and regulation applies to product safety?
Within the Swedish Consumer Agency’s area of supervision:
Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, also called the General Product Safety Regulation (GPSR).
Swedish Act (SFS 2011:579) on Toy Safety and Ordinance (SFS 2011:703) on Toy Safety. Specific requirements for toys are also found in regulations issued by the Swedish Consumer Agency, National Electrical Safety Board and Swedish Chemicals Agency.
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.
Swedish Act (SFS 2018:125) and Ordinance (SFS 2018:127) with Supplementary Provisions to the EU's Regulation on Personal Protective Equipment.
Swedish Product Safety Act (SFS 2004:451) and Product Safety Ordinance (2004:469).
Standards, CE marking.
Your responsibility for a product varies depending on whether you are the manufacturer, importer, distributor or some other economic operator. You must establish which role you have.
Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, also called the General Product Safety Regulation (GPSR), entered into force on 13 December 2024. The Regulation applies in all EU/EEA countries.
GPSR applies to all consumer products. Only certain parts of GPSR apply to products covered by EU harmonisation legislation. You can learn more further down the page under “GPSR and EU harmonisation legislation”.
Examples of products covered by GPSR in its entirety:
Furniture
Clothing
Jewellery
Sports equipment unless classed as protective equipment
Products for children, such as prams, pacifiers and cots
Some of the most significant changes
One of the most significant changes with regard to general product safety is that GPSR also regulates e-commerce and new technologies. It also imposes somewhat stricter requirements on product safety and clarifies the specific responsibilities of manufacturers, importers, retailers and other economic operators.
Economic operators, as businesses are referred to in GPSR, are also required to put in place internal processes such as guidelines, standards and operational procedures for product safety.
There must be a responsible economic operator established in the EU
A product covered by GPSR shall not be placed on the market unless there is an economic operator established in the EU who is responsible for regulatory compliance. If neither the manufacturer nor their representative nor the importer are established in the EU, then a distributor established in the EU must be responsible for the product. Among other things, the responsible economic operator must ensure that technical documentation and safety information concerning the product is available to the authorities.
Traceability requirements have been tightened
Manufacturers must ensure that their products are traceable. The name, registered trade name or registered trade mark, and contact details, including the postal and electronic address, of the responsible economic operator must therefore be indicated on the product or on its packaging or accompanying paperwork. Products must also bear a type, batch or serial number or some other designation to allow the consumer to identify the product, or where the size or nature of the product does not allow it, the required information must be provided on the packaging or in a document accompanying the product.
Requirements for online marketplaces
The requirements of GPSR apply equally regardless of whether the product is sold in a physical location or online. The new rules require providers of online marketplaces – i.e., providers of intermediary services through which consumers can conclude distance contracts with traders for the sale of products – to ensure that they have internal processes for product safety in place.
Providers of online marketplaces shall design and organise their online interface in a way that enables traders offering the product to provide the manufacturer’s contact details and information that allows consumers to identify the product.
If the provider of an online marketplace has a dangerous product on their website, they must cooperate with market surveillance authorities, including removing specific content advertising the dangerous product from their platform when ordered to do so.
More information required when distance selling
Anyone selling a product online or through some other form of distance selling is now required to provide more information than previously. Among other things, products must be clearly marked with any warnings and other safety information, and this information must be available on the platform where the product is offered for sale.
Notifying the authorities about accidents
In the event that a product causes an accident that has a serious adverse effect on an individual’s health, the manufacturer shall ensure that the competent authorities of the Member State where the accident has occurred are notified.
Compensating consumers when products are recalled
In the event of a product safety recall, consumers who have purchased the product shall be offered the choice between at least two of the following remedies:
the repair of the recalled product,
a replacement of the recalled product with a safe one of the same type and at least the same value and quality or
a refund of the value of the recalled product at least equal to the price paid by the consumer.
Consumers must be able to complain
Manufacturers and importers must ensure that communication channels are available so that consumers can submit complaints. Manufacturers are also required to keep an internal register of complaints and product recalls.
Summary of your most important obligations
As an economic operator (business), you must:
ensure that all products you supply are safe and fulfil all requirements for marking, user instructions, etc.;
have internal product safety processes that fulfil the requirements of GPSR;
cooperate with market surveillance authorities to remove or mitigate any risks associated with the products your business releases onto the market;
make specific product information available to the authorities (risk assessments, complaints and measures to address faults) for ten years, and information on supply chain traceability for six years;
notify the authorities about accidents caused by a product;
directly inform all affected consumers about safety warnings, if the product is recalled then using a mandatory template for recall notices; and
offer consumers a choice between at least two of the following alternatives if a product is recalled: refund, repair or replacement.
Additional information about GPSR
The EU has published a summary of the General Product Safety Regulation on its website. The Regulation is also available in its entirety in the official languages of the EU.
There is also secondary legislation supplementing GPSR, including a Commission implementing regulation for the interface of the Safety gate portal for the providers of online marketplaces.
GPSR supplements the EU’s harmonised product legislation. GPSR contains general safety requirements and aspects for assessing the safety of products intended to fill gaps and to complement provisions in existing or forthcoming sector-specific EU harmonisation legislation. So, it also applies to products covered by harmonisation legislation.
It is intended to ensure that all consumer products are safe and meet certain minimum requirements concerning marking, user instructions, etc.
The following chapters in GPSR also apply to consumer products that are covered by specific requirements in EU harmonisation legislation:
- Chapter I: General Provisions
- Chapter II: Safety Requirements (for risks or categories of risks not covered in EU harmonisation legislation)
- Chapter III, Section 2: Obligations of economic operators in the case of distance sales, obligations of economic operators in the case of accidents related to safety of products, and provisions on information in electronic format
- Chapter IV: Providers of online marketplaces
- Chapter VI: Safety Gate Rapid Alert System and Safety Business Gateway
- Chapter VIII: Right to Information and to a Remedy
Certain types of consumer products are covered by separate legislation containing harmonised requirements for the products themselves or the risks they may pose. These include toys, personal protective equipment (PPE) and consumer electronics.
In addition to meeting safety requirements, the manufacturers of these products must ensure that they comply with all regulations concerning marking and documentation. As a manufacturer, you are required to perform a risk assessment and ensure that your products comply with all regulations before they are launched on the EU market. This is called a compliance assessment. It must be performed during both the design and manufacturing phases.
Although the EU General Product Safety Regulation (GPSR) entered into force in December 2024, the provisions of the Swedish Product Safety Act (SFS 2004:451) continue to apply to services provided in Sweden.
The Product Safety Act also applies to products that are not specifically covered by EU harmonisation legislation if they were launched on the market before 13 December 2024. Products launched from 13 December 2024 onwards are covered by GPSR.
Product safety legislation contains only general safety requirements (GPSR) or, in the case of harmonising legislation, basic requirements. More detailed safety requirements can be found in standards prepared by the European Standardisation Organisations. While in most sectors the application of these standards is voluntary for manufacturers, a product that meets the requirements specified in the standard is also assumed to meet statutory safety requirements to the extent these are regulated by the standard.
Testing a product in relation to an applicable standard is often the easiest way to make sure that it fulfils requirements. However, as a manufacturer, rather than applying the standard, you may choose to demonstrate that the product meets applicable requirements in some other way.
CE marking is obligatory for products for which EU specifications exist and require the affixing of CE marking. These include toys and PPE. It is not permitted to sell such a product unless it is correctly CE marked. It is therefore vital that you are aware of which of your products need to be CE marked. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
The Market Surveillance Council has compiled a list of EU directives and regulations that apply to various products. The Council’s product legislation guide also provides information on the authority responsible for market surveillance in each product area.
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