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General product obligations
What are the basic laws governing the safety requirements that products must meet?
The general product safety requirements are regulated by the Product Safety Act (2004:451), implementing the provisions of Directive 2001/95/EC into Swedish law. The Product Safety Act applies to goods and services that are supplied commercially and also to goods that are supplied in the course of public activities, provided that the goods are intended for consumers or likely to be used by consumers. The Product Safety Act does not apply to second-hand goods that are supplied as antiques. Neither does the Product Safety Act apply to goods that have to be repaired or reconditioned before they can be put into use.
Since the provisions of the said law are, in principle, general and abstract, manufacturers of products may demonstrate compliance with product safety legislation (and benefit from the presumption of safety) by complying with Swedish standards that implement a European standard. A product that complies with such standards is presumed to be safe.
In addition to the general rules of the Product Safety Act, there are special laws in Sweden, most of them implementing the provisions of relevant EU directives, regulating a variety of particular products. For instance, such laws are the Supplementary Rules to EU Regulation on Personal Protective Equipment (2018:125), the Act on Toy Safety (2011:579), the Act on Medical Devices (1993:584) or the Regulation on Electrical Safety (2017:218).
Safety requirements are not only set by direct rules of the above-mentioned laws, but also indirectly, by means of liability regimes. Such liability provisions are enshrined in the Product Liability Act (1992:18), the Tort Liability Act (1972:207), the Consumer Sales Act (1990:932) and the Sales of Goods Act (1990:931).
What requirements exist for the traceability of products to facilitate recalls?
The Product Safety Act obliges producers to label the goods or the packaging of the goods, indicating the name and address of the producer together with a reference to the goods or the consignment of goods to which they belong (unless such labelling is obviously unnecessary). The producers are also obliged to review and keep record of received complaints relating to product safety. The distributors are obliged under the Product Safety Act to communicate all information to the producer relating to the risks of injury from the goods (unless obviously unnecessary) and to maintain documentation that is necessary to trace the origin of the goods. Such documentation has to be preserved for the term of five years from the end of the fiscal year in which the relevant goods were acquired. The Product Safety Act sets forth the said obligations as injury prevention measures.
What penalties may be imposed for non-compliance with these laws?
According to the Product Safety Act, the supervisory authority may issue orders and injunctions (including export prohibitions) that are subject to default fines. Such default fines are administrative by nature. The Product Safety Act sets out the possibility to impose sanction fees in the event of breach of certain provisions of the act, conducted intentionally or by neglect. Such fees may also be imposed pursuant to the specific laws regulating particular products if certain provisions of the said acts are infringed. The fee may range between 5,000 and 5 million kronor; however, it may not exceed 10 per cent of the fined undertaking’s annual turnover. The imposition of the fee is decided by an administrative court upon application by the competent supervisory authority.
There are no criminal sanctions in the Product Safety Act or Product Liability Act. Non-compliance with product safety rules may indirectly lead to liability for damages under the relevant liability regimes, most notably pursuant to the Product Liability Act.
Reporting requirements for defective products
What requirements are there to notify government authorities (or other bodies) of defects discovered in products, or known incidents of personal injury or property damage?
Under the Product Safety Act, undertakings (ie, a natural or legal person acting for purposes relating to their own business operation) have notification obligations towards the supervisory authority. Such a notification obligation is to be fulfilled immediately when the undertaking becomes aware that the goods that it provides or has provided are dangerous. The undertakings are also required to notify the supervisory authority about the measures that have been implemented in order to prevent the occurrence of an accident.
Additional provisions regarding the notification obligation may apply pursuant to the specific laws as mentioned under question 1. For instance, under the Toy Safety Act, an economic operator considering a toy to entail any risks pursuant to the act must notify the relevant supervisory authorities within the EU member states where the toy was made available or offered.
Notification criteria and time limits
What criteria apply for determining when a matter requires notification and what are the time limits for notification?
The notification has to be made immediately when it becomes apparent to the undertaking that the provided goods are dangerous. Under the Product Safety Act, the supervisory authority does not have to be notified if it is manifestly clear that such notification would be of no importance. However, certain product safety regimes do not allow for such exception, for instance, the Toy Safety Act.
To which authority should notification be sent? Does this vary according to the product in question?
Notification under the Product Safety Act relating to products not falling under the special sectoral laws is required to be submitted to the Swedish Consumer Agency. Moreover, the Swedish Consumer Agency has competency with respect to notifications pursuant to the Supplementary Rules to EU Regulation on Personal Protective Equipment and the Toy Safety Act. In addition to the general competency of the Swedish Consumer Agency, with respect to certain categories of goods, other supervisory authorities may have competence, such as the Swedish Work Environment Authority, the Swedish Board of Agriculture, the Medical Products Agency and the Swedish Chemicals Agency.
What product information and other data should be provided in the notification to the competent authority?
According to the Product Safety Regulation (2004:469), the written notification should include information allowing for the identification of the dangerous product, together with a full description of the risks associated with such dangerous product. The written notification must also include all available information that may be necessary in order to trace the product and a description of the measures implemented in order to prevent risks that may occur to consumers. In addition to these essential requirements, the supervisory authorities may require further information or may regulate notification proceedings.
Obligations to provide updates
What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?
Undertakings, including producers and distributors, are obliged to inform and to cooperate with each other and with the supervisory authority in order to avoid risks associated with products. Moreover, the supervisory authority may set up oversight programmes in which undertakings are required to cooperate by providing updates. The notification obligation pertains to all information relating to risks (see also question 7) including updated information. If the supervisory authority requests information, the conditions set forth in such individual request will apply.
What are the penalties for failure to comply with reporting obligations?
Non-compliance with the notification obligation may serve as a ground for an administrative fine to be imposed under the Product Safety Act, as discussed in question 3.
Is commercially sensitive information that has been notified to the authorities protected from public disclosure?
The Product Safety Act prohibits any person in private practice who dealt with a case involving supervision under the act to, without authorisation, disclose or utilise any information that has been acquired regarding any party’s business or operational circumstances.
For authorities confidentially applies in certain supervision matters in relation to information about the business of a party or financial information if it can be assumed that disclosure would lead to damage (the Public Access to Information and Secrecy Act (2009:400)).
Use of information in prosecution
May information notified to the authorities be used in a criminal prosecution?
Yes. Under the Swedish procedural rules, the principle of free evidence applies. A party is free to disclose any information it has available as evidence.
Product recall requirements
What criteria apply for determining when a matter requires a product recall or other corrective actions?
As discussed above, the Product Safety Act obliges the undertaking to notify the supervisory authority if the provided goods are dangerous. Moreover, according to the Product Safety Act, the producer has to without delay provide warning information or recall supplied goods when it becomes apparent that the goods are dangerous, if it is necessary to prevent the occurrence of an accident. The producer is obliged to arrange the immediate destruction of the goods (or to make the goods otherwise harmless) if they are particularly dangerous.
The goods are dangerous if they do not meet the requirements of safety that are enshrined in the Product Safety Act. According to the Product Safety Act, a product is safe if, upon normal or reasonably foreseeable use and lifespan, it does not entail any risks to the health or safety of natural persons, or only a low risk. This risk, however, must be acceptable considering how the goods or services are used; and it should be consistent with a high level of protection with respect to the health and safety of persons. Thus, in general, the harmfulness of the product has to be unexpected, meaning that the risks have to occur contrary to what the consumer may expect from the particular product.
The assessment of the risk must be carried out with the following factors taken into account:
- the characteristics of the product, such as its composition and packaging and the instructions for assembly, installation and maintenance;
- other information provided concerning the product by means of labelling, warnings, user instructions, instructions for disposal, among others;
- the effect of the product concerned on other products, if it can be assumed that it will be used together with other products; and
- the risks that the product may entail for certain categories of consumers, in particular for children and older persons.
What are the legal requirements to publish warnings or other information to product users or to suppliers regarding product defects and associated hazards, or to recall defective products from the market?
The producers, under the Product Safety Act, are obliged to provide safety information that is necessary in order to enable the consumers to assess the risks that the goods may entail and to protect themselves against these risks. The obligation to provide consumers with safety information does not only cover high risks of damage, but also any information that is necessary with respect to risks, as this obligation is not preconditioned upon whether the product is dangerous or not as defined by the Product Safety Act.
However, safety information is not required to be provided if the risk is obvious. According to the Product Safety Regulation, the safety information is required to be marked on the product or to be included in the manual of the product, or in another form at the point of sale, in advertisements or in any other form that the consumer requests. According to the Swedish Consumer Agency the information must be in Swedish. Furthermore, if the product is sold over the internet, the information must be available to the consumer before purchase (www.konsumentverket.se/for-foretag/produktsakerhet/).
The Product Safety Act imposes on producers the obligation of providing warning information if the supplied goods are dangerous (as discussed in question 12). The producer should provide, without delay, warning information about the risk of injury and the manner in which an injury can be avoided, where it is necessary in order to prevent the occurrence of an accident. The warning information has to be provided to the extent that is reasonable considering the need to prevent the occurrence of any accidents.
In addition to the above (question 12) discussed requirements regarding product recall, the producers are obliged to recall the dangerous goods from the distributors. If this measure is insufficient in order to prevent the occurrence of an accident, the producers should recall the dangerous goods directly from the consumers who possess the goods. The recall is required to take place to the extent that is reasonable considering the need to prevent the occurrence of any accidents.
Are there requirements or guidelines for the content of recall notices?
The recall notice should include information regarding the risks of damage. Such information should facilitate the purpose of preventing accidents. The producer should, in the recall notice, offer rectification, replacement or rescission (see question 17), and provide information on the conditions of such offer. According to the Swedish Consumer Agency, the information must state that the product is not safe and why. The recall notice must be easy for the consumer to understand (ie, what needs to be done to ensure the product is safe - eg, repair, etc). The revocation must be valid for a reasonable period and the recall must occur without significant costs or inconvenience for the consumer (www.konsumentverket.se/for-foretag/produktsakerhet/salt-farlig-vara/).
What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?
The warning information should be addressed directly to the persons in whose possession the dangerous goods are, for instance, by means of direct notices, advertisements or other means of communication that the producer uses in its marketing. The same applies to the recall notice. While warning information placed on the package of a product may serve the purpose of preventing injuries and accidents in cases where the product entails danger only for certain consumers (eg, children), a notice concerning the recall of highly dangerous products addressed directly to consumers might require the use of widespread media, such as advertisements on television, or in newspapers and online news sites. According to Swedish Consumer Agency, a recall notice should be published in newspapers, on the company’s website or on an appraisal at the store and preferably on the relevant market surveillance authority’s website.
Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?
There are no such provisions in the law as a recall is satisfactory if it effectively prevents the occurrence of any injuries. According to the Swedish Consumer Agency, the recall period must be reasonable but there are no guidelines for the length of the period.
Repair and replacement
Must a producer or other supplier repair or replace recalled products, or offer other compensation?
The producer is required to offer rectification of the defect associated with the risk of injury, or replace the product with a defect-free version of the same or corresponding type, or take the product back and provide compensation therefor.
What are the penalties for failure to undertake a recall or other corrective actions?
The omission of providing safety information or warning information as well as failure to carry out a product recall may be sanctioned by the imposition of a fine. Moreover, non-fulfilment of the order of the supervisory authority concerning a recall or other corrective measures may lead to the imposition of the conditional fine set forth in the order. Non-compliance with the injury prevention measures (see question 2) may also lead to fines.
What powers do the authorities have to compel manufacturers or others in the supply chain to undertake a recall or to take other corrective actions?
The supervisory authority has wide powers to ensure compliance with the Product Safety Act and the related laws and regulations. The supervisory authority may order an undertaking to provide information, documents, product samples and such like. The supervisory powers include the entitlement to access the premises or spaces other than residences where goods are handled. The supervisory authority may issue orders or injunctions, suspend the supply or exhibition of goods for the duration of an investigation and prohibit the export of particularly dangerous products. Such orders and injunctions may be addressed to each of the undertakings that provide or have provided, take into or have in their possession a dangerous product. The fulfilment of the supervisory authority’s orders and injunctions, as discussed previously, may be enforced by conditional fines.
The supervisory authority should commence negotiations with undertakings to voluntarily undertake measures in order to avoid the occurrence of an accident, unless the circumstances of the case do not allow for such solution (eg, due to urgency). It is also in the power of the supervisory authority to publish warning information, if an order cannot be issued concerning warning information or product recall because there is no undertaking to oblige. Finally, the supervisory authority may file, with the competent administrative court, an application for the imposition of a fine.
Can the government authorities publish warnings or other information to users or suppliers?
Yes, the supervisory authority is obliged to carry out monitoring programmes, about which it has to inform the public. Moreover, consumers can report incidents concerning products entailing risks or danger via the website of the Swedish Consumer Agency.
Can the government authorities organise a product recall where a producer or other responsible party has not already done so?
The supervisory authority is not entitled to organise a product recall, however, it may commence negotiations with undertakings to voluntarily carry out a product recall or may order undertakings to recall dangerous products. If there is no undertaking that could be obliged to publish warning information or to recall dangerous products, the supervisory authority should publish warning information.
Are any costs incurred by the government authorities in relation to product safety issues or product recalls recoverable from the producer or other responsible party?
The Product Safety Act provides for compensation for the costs of samples or tests of goods requested by the supervisory authority if there are special reasons for compensation.
How may decisions of the authorities be challenged?
Decisions of the supervisory authority concerning orders or injunctions (see question 19) and compensation (see question 22) may be appealed before an administrative court. However, a supervisory authority may render its decision concerning an order or injunction to enter into force immediately, in order to ensure high-level consumer safety. The decision of a general administrative court may be appealed to the Administrative Court of Appeal if a leave to appeal is granted.
Implications for product liability claims
Implications for product liability claims
Is the publication of a safety warning or a product recall likely to be viewed by the civil courts as an admission of liability for defective products?
The publication of warning information or the recall of products cannot be deemed, per se, as an admission of liability under the Product Liability Act. Publication of warning information or a product recall is required to be applied if the goods are dangerous pursuant to the Product Safety Act. Product liability may arise if a defective product causes damage (meaning personal injury or damage to consumer property).
Product liability may be established if the injured person furnishes evidence that a defective product has caused damage and the producer (or supplier or distributor) cannot exonerate itself by means of the exhaustive list of applicable defences. A product is defective pursuant to the Product Liability Act if it does not provide the safety that is reasonable to expect from such a product, taking the following into account:
- the expected use of the product;
- how the product has been presented and marketed;
- manuals and other instructions issued with the product; and
- the time when the product was put into circulation and other relevant circumstances.
Since the notions ‘dangerous product’ under the Product Safety Act and ‘defective product’ under the Product Liability Act are similar, a product recall may contribute to finding the product defective under the Product Safety Act. However, in addition to establishing the defect of the product, the injured person is also required to prove the damage and the causality between the defect and the damage.
Can communications, internal reports, investigations into defects or planned corrective actions be disclosed through court discovery processes to claimants in product liability actions?
A party in an ongoing court procedure can request disclosure of documents that are located with the counterparty or a third party. The request for disclosure will be tried by the court and may be granted if the documents are sufficiently identified and relevant as evidence in the case. For an authority, it will also have to take into account the legislation on confidentiality.