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Products and services offered to consumers must have a high level of protection. If you have reason to believe that a product or service may be dangerous, you are responsible for taking measures to protect consumers from harm. You must also inform the relevant supervisory authority and explain which measures you have taken to prevent injury. Accidents related to product safety must also be reported.
Translated page: This text has been translated from Swedish. The text and appearance of the page may look different from the original page.
On this page:
Responsibility for product safety
Risk assessment and corrective measures
Reporting accidents
Templates and guides for notification and recall
Safety Gate EU rapid alert system
Dangerous products – recall
Notification of dangerous products in the public sector
When assessing whether a risk associated with a product is acceptable, particular consideration should be given to:
the nature of the product, such as its composition, packaging and instructions for assembly, installation and maintenance;
other information that is provided about the product through marking, labelling, warnings and instructions for use;
the effect of the product on other products that it might be expected to be used with;
the presentation of the product, marking, any warnings and user manual/other instructions;
risks that may be associated with the product for certain groups of consumers, especially children and the elderly;
the appearance of the product, if its appearance is likely to induce consumers to use the product in a manner other than that for which it was designed; and
when the nature of the product so requires, the cybersecurity aspects of the product and its development, learning and predictive functions.
Measures for dangerous products
Corrective measures that may be necessary when a dangerous product has been sold include safety warnings and/or the withdrawal or recall of the product. An assessment must be made on a case-by-case basis as to whether a safety warning combined with the withdrawal of the product from companies that hold stock will be sufficient, or whether a recall of the product from consumers is necessary to remove the danger. When initiating a recall, the manufacturer must offer at least two of the following alternatives:
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.
Your corporate responsibility
As a business owner, you are responsible for ensuring that a recall is as effective as possible and that the dangerous product is taken off the market. All affected consumers that it is possible to identify must be directly informed without undue delay. If personal data concerning consumers has been collected, this must be used for the purpose of issuing recalls and safety warnings.
If it is not possible to reach all consumers directly, a recall notice must be published on, for example, the company’s website, social media platforms, newsletters and sales points. It must also be published in the daily and/or trade press and other communication channels that ensure the greatest possible range.
A recall notice must be clearly headed “Product safety recall” and include the following information:
a clear description of the recalled product, including a picture, name and brand of the product; product identification numbers, such as batch or serial number, and, if applicable, graphical indication of where to find them on the product; information on when, where and by whom the product was sold, if available;
a clear description of the hazard associated with the recalled product, avoiding any elements that may decrease consumers’ perception of risk, such as by using terms and expressions such as ‘voluntary’, ‘precautionary’, ‘discretionary’, ‘in rare situations’ or ‘in specific situations’ or by indicating that there have been no reported accidents;
a clear description of the action consumers should take, including an instruction to immediately stop using the recalled product;
a clear description of the remedies available to consumer, offering at least two of the three aforementioned alternatives;
a free phone number or interactive online service, where consumers can get more information in relevant official EU language(s); and
encouragement to share the information about the recall with other persons, if appropriate.
As soon as you become aware that a product has caused an accident, you must notify the competent authorities of the Member State where the accident occurred without undue delay. Notification is submitted via the Safety Business Gateway.
The notification shall include the type and identification number of the product as well as the circumstances of the accident, if known. The manufacturer shall notify, upon request, to the competent authorities any other relevant information.
The manufacturer’s notification obligation
The manufacturer shall notify the competent authorities of the occurrences associated with the use of a product that resulted in an individual’s death or in serious adverse effects on that individual’s health and safety, permanent or temporary, including injuries, other damage to the body, illnesses and chronic health effects.
The notification obligation of other economic operators
Importers or distributors which have knowledge of an accident caused by a product that they placed or made available on the market shall without undue delay inform the manufacturer thereof. The manufacturer shall then make the notification via the Safety Business Gateway, or instruct the importer or one of the distributors to make the notification. Where the manufacturer of the product is not established in the Union, the economic operator with responsibility for the product on the EU market shall ensure that the notification is made.
When recalling products from the Swedish market, the recall notice must be in Swedish. The template prepared by the European Commission is easy to understand and covers all compulsory information.
If the product has been sold in other Member States and you need templates in other languages, these are available on the EU Safety Gate website (select a language at the top of the page).
If you have sold a dangerous product, you must inform the manufacturer or importer of this. You must also immediately notify the competent market surveillance authorities where the product has been supplied on the EU single market. You submit notification via the Safety Business Gateway, unless the manufacturer or importer has already done so.
When you submit a notification, the information will be sent to the Member States you select, so you do not need to find out which authority is responsible for market surveillance in that country. To create a notification, you will need an EU Login. To create a login, click on “Get started” on the Safety Business Gateway homepage. If you would like further information about the system, an English-language user manual is available.
Please note that a notification does not always lead to a notification in the Safety Gate EU rapid alert system. The supervisory authority assesses whether notification should be made.
Market surveillance authorities within the EU cooperate to inform one another of products against which measures have been taken due to safety flaws. Such measures include withdrawal from the market and recalls from consumers. The authorities report products via the Safety Gate EU rapid alert system.
The European Commission compiles this information in a weekly list with pictures and descriptions, which is published on the Safety Gate website. Information received from the system is processed by the competent authorities in Sweden to find out if the products in question are sold on the Swedish market.
Information received from Safety Gate is processed to find out if the products in question are sold on the Swedish market. If a product on the list is available on the Swedish market, the competent authority will assess whether measures need to be taken by economic operators in Sweden.
The Swedish Consumer Agency is the Swedish point of contact for the EU Safety Gate system.
Subscribe to reports from Safety Gate
You can subscribe to weekly reports from Safety Gate. While you can choose to receive automatically generated reports in Swedish, we recommend reading reports in English to avoid any errors in translation.
Product safety recalls from the Swedish market are published under “Aktuellt” (News) on our website. We publish recall notices for products with serious defects or that are used by many consumers.
Safety defects are sometimes discovered in products sold outside the EU. A list of product safety recalls at global level is available on the OECD website.
Certain rules are different if you have supplied a dangerous product to the public sector. Use our form or contact the Swedish Consumer Agency for further information.
As a service provider, you have a responsibility to minimise the risk of personal injury and ensure that the service has a high level of protection. When assessing whether a risk associated with a service is acceptable, particular consideration should be given to:
how the service is performed;
safety information provided by the trader;
the effect of the service on products, if it can be assumed that the safety of the product may be affected by how the service is performed; and
risks that may be associated with the service for certain groups of consumers, especially children and the elderly.
If you become aware that a service you provide or have provided is dangerous, you have an obligation to immediately inform the Swedish Consumer Agency or another competent authority. You also need to notify the competent authority of the measures you have taken, or intend to take, to prevent further harm. A serious incident or accident is often a clear indication that a service is dangerous and that notification must be made. Even minor incidents or accidents may warrant notification if you have reason to doubt the safety of the service.
The Swedish Consumer Agency’s notification form can be used when you need to notify the competent authority of a dangerous service.
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