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General product obligations
What are the basic laws governing the safety requirements that products must meet?
The main rules regarding product safety are found in the Product Safety Act, which implements EU General Product Safety Directive 2001/95 (Directive 95/2001 EC). The Product Safety Act applies to consumer products and products that under foreseeable circumstances could be used by consumers, although they might not be intended for them.
Further to this, the Danish Working Environment Act contains rules regarding the health and safety of workers as well as rules about products used in the work process.
The Danish rules on product liability are also relevant and can be found in the Product Liability Act and through principles developed in case law. Whereas the Product Liability Act only governs consumer products, the product liability developed through case law also governs commercial products and generally has a wider field of application, and these rules therefore work in tandem when it comes to establishing the basis of a claim for damages where a defective product has caused damage.
It is also possible to find numerous sector-specific rules regarding specific types of products. Many of these sector-specific rules stem from the EU and have been implemented in Denmark. Examples of such rules can be found within the areas of electrical products, food, drinks, cosmetics, toys, etc. However, it is important to note that unless otherwise stated, the rules regarding specific types of products are supplemented by the Product Safety Act.
What requirements exist for the traceability of products to facilitate recalls?
It is required that a manufacturer takes the necessary steps to avoid a product posing a danger to consumers, such as warning the consumer in an effective way, withdrawing or recalling a dangerous product. In taking such steps, the manufacturer may place relevant product information on the product or its packaging, including a reference number, product identity, the name and address of the manufacturer, etc. If the manufacturer can secure an effective recall in other ways without marking the products, this will be sufficient. From both a legal and commercial point of view, marking the products in a way that is sufficient to locate and identify a batch of defective products is always recommended since sufficient product identification combined with a procedure of locating the whereabouts of a defective batch of products can go a long way in limiting the number of people exposed to the risk of the defective products and the costs and efforts needed to ensure effective recall.
Manufacturers that have not produced the product themselves, for example, a representative in Denmark, must, when relevant, keep the documentation necessary to trace the product. This documentation must be kept during the expected lifetime of the product, although no longer than five years from the end of the financial year in which the product was marketed.
Distributors must also take part in the product supervision by supplying information to the manufacturer and the authorities about risks related to the product and by storing and supplying the documentation necessary to trace the product (eg, the date of purchase and the contact information of the seller involved in previous stages of sale and marketing). This information must be kept during the expected lifetime of the product, although no longer than five years from the acquisition by the distributor of the product.
Further to this, a number of sector-specific rules regarding the traceability of products exist. Examples of such sector-specific rules can be found within the areas of food, drinks and pharmaceuticals.
What penalties may be imposed for non-compliance with these laws?
Generally, non-compliance can be sanctioned in two ways. First, fines may be administratively imposed under the Product Safety Act. In order for fines to be imposed under the Product Safety Act, the act provides that for some offences breach of the rules must be intentional, while in other cases gross negligence or the mere existence of a breach is sufficient. Distributors and manufacturers do, however, often voluntarily take the necessary steps to cooperate with the authorities.
Second, it is possible to sanction an offence by imprisonment according to more general provisions of the Danish Criminal Act. If a product poses a threat to humans, and the manufacturer or distributor nevertheless sells (or tries to sell) the product, he or she may be convicted of endangering other people’s lives, and can, in serious cases - for instance, if the contamination of the product is sought to be hidden - receive a prison sentence of up to 10 years.
Further to this, sector-specific rules allow for administratively imposing penalties, for example, within the areas of food, drinks, pharmaceuticals, toys, etc.
The size of the fines depends on what rules have been breached. Factors influencing the size of the fines under the Product Safety Act are, among others, the number of accidents, whether there have been repeating offences and the revenue of the firm breaching the rules.
From a commercial point of view, the most serious way of sanctioning non-compliance with product safety laws is for the authorities to issue injunctions with a requirement to warn the consumer, remedy the circumstances that have resulted in the danger, destroy, withdraw or recall the product, or take these measures themselves. See question 19 for further information.
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?
According to the Product Safety Act, both the manufacturer and the distributor have an obligation to inform the enforcement authority (in most cases the Danish Safety Technology Authority (DSTA)) about consumer products that are considered not to be safe. The information about the dangerous product can come from internal investigations, reports, known accidents, product complaints, etc. Further to this, the manufacturer must seek out information on the risks related to the consumer products. This can be done in several ways, including by performing random tests, processing complaints and by notifying the distributors about the product surveillance in order to give them a better basis for assessing and reporting risks and accidents.
The distributor takes part in the product surveillance by passing on information about the risk related to the product to the manufacturer and the authorities and by keeping the information necessary to track the origin of the products.
Apart from the notification about the dangerous product, both the manufacturer and the distributor must notify the authorities about the measures taken to avoid risks.
There is no general set of combined rules that applies to products, and the relevant rules regarding such products must therefore be found within the sector-specific legislation. These rules will, generally, apply to both consumer and non-consumer products. Examples of such sector-specific rules are within the areas of food, drinks and pharmaceuticals.
Notification criteria and time limits
What criteria apply for determining when a matter requires notification and what are the time limits for notification?
According to the Product Safety Act, if a product is considered to be unsafe, a notification must be sent to the DSTA immediately. A product is safe when there is no risk, or only a limited and acceptable risk, for consumers, when the product is used under normal and predictable circumstances, and within the expected lifetime of the product. A product is generally considered safe when it is manufactured according to health and safety requirements. There is a presumption that the product is safe when it is manufactured according to Danish health and safety regulations incorporating certain European standards. If no such health and safety regulations exist the safety of the product is assessed based on the actual circumstances.
The assessment of whether or not a notification is sent immediately will depend on the concrete circumstances of the case.
To which authority should notification be sent? Does this vary according to the product in question?
The question of which authority the notification should be sent to depends on the product in question. However, if the notification is sent to the wrong authority, there is a general obligation for the Danish authorities to pass on communications to the relevant authority.
Notifications according to the Product Safety Act must be sent to the DSTA, which also coordinates the information exchanged through the European RAPEX system. Notifications may also be sent electronically via the Product Safety Business Alert Gateway on the European Commission’s website.
Other authorities are responsible for sector-specific notifications:
Food and drink
The appropriate authority to contact in a recall situation is the Danish Veterinary and Food Administration. The Danish Veterinary and Food Administration ensures that the recall is published on its website.
Outside ordinary opening hours, it is possible to contact the Food Guard.
The appropriate authority to contact when discovering a problem with pharmaceuticals is the Danish Medicines Agency. Outside ordinary opening hours, an emergency number can be reached.
What product information and other data should be provided in the notification to the competent authority?
The information requested reflects Appendix I to Directive 95/2001 EC. Based on the information, it must be possible to identify the product. Therefore, information must be provided about the risk of the product, who may have bought the product, where it is sold, how many products have been sold, the measures taken to avoid risk from occurring and generally information that can help trace and recall the product.
If the information necessary cannot be found with the manufacturer or distributor, the authorities can, among other things, perform tests and collect samples of the product or components thereof without payment.
Obligations to provide updates
What obligations are there to provide authorities with updated information about risks, or respond to their enquiries?
As described in question 4, both distributors and manufacturers have an obligation to monitor the products and notify the DSTA if the products are considered not to be safe. Distributors and manufacturers are also under an obligation to cooperate with the authorities to the greatest extent possible.
The authorities may also demand information about any preconditions or measures taken and the result of such. Further to this, the authorities may demand any information and documents they may find necessary irrespective of whether or not the information is considered commercially sensitive.
The DSTA will usually follow up on recalls and in this respect urge the manufacturer to provide updated information about the measures taken and the status of the recall. If the circumstances of the case then prove to be unsatisfactory, the manufacturer must take new steps to secure a satisfactory recall.
The authorities may also, if necessary, without a court order, gain access to the premises or transport facilities of a distributor or manufacturer in order to obtain information, documents, and such like.
What are the penalties for failure to comply with reporting obligations?
Failure to comply with the obligation to report is penalised with a fine. In rare cases, imprisonment can be the result. For more information, see question 3.
Is commercially sensitive information that has been notified to the authorities protected from public disclosure?
According to the Product Safety Act, the authorities have an obligation to, when possible, disclose information to the public about the risk related to dangerous products, the measures taken, how to identify the product, how the consumer should act, among others. The authorities may only disclose commercially sensitive information if this is necessary to protect the health and safety of consumers. If the health and safety of the consumer can be secured without disclosing such information, the authorities may not disclose it.
The authorities in Denmark are under a general obligation to provide certain information related to specific cases. As a general rule, access to such information does not include certain types of commercially sensitive material. In cases where documents or the like contain both commercially sensitive and non-sensitive information, access can be given to the non-sensitive information.
Use of information in prosecution
May information notified to the authorities be used in a criminal prosecution?
It is highly probable that the information gathered by the authorities will be used in a criminal prosecution.
Product recall requirements
What criteria apply for determining when a matter requires a product recall or other corrective actions?
If a product is considered to be unsafe (see question 5), the manufacturer must take the necessary precautions to avoid the product posing a risk to consumers. This could be anything from warning the consumer in an effective way to a complete withdrawal or recall, depending on the circumstances of the case. It is not possible to lay down specific legal criteria for determining when a given action is appropriate, but some guidance may be found in ‘Product Safety in Europe - A Guide to Corrective Action Including Recalls’. Generally, both the manufacturer and the authorities are to assess the situation from a principle of proportionality and from the present, specific risk. A complete recall is, however, considered the last resort, and irrespective of the measures taken the manufacturer may not continue to market an unsafe product.
Food and drink
Recalls of food and drinks are mainly governed by EC Regulation 178/2002. A recall is generally necessary if there is suspicion that the product does not comply with the food safety requirements.
It is possible for the Danish Medicines Agency to demand a recall of pharmaceuticals in a number of cases, for example, if the therapeutic effect is lacking, the risk of the product outweighs the benefits, the product does not have the correct qualitative or quantitative composition and so on. The response time of the Danish Medicines Agency is divided into three classes:
- class 1: potentially life threatening - immediate action;
- class 2: can cause sickness or improper treatment - action within 24 hours; and
- class 3: others, no patient risk - action within two to three working days.
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?
Publishing warnings is just one of several possible actions to be taken in case of a dangerous product. If a product is considered to be unsafe, the manufacturer has an obligation to take the necessary steps to avoid the product posing a risk to the consumer. This is usually done by warning the consumer, withdrawing or recalling the product. The method used will depend on the circumstances of the case, but it is important that the actual measure taken prevents the product from posing a risk to the consumer.
To ensure the effectiveness of the measures taken, manufacturers are advised to place relevant product information on the product or its packaging, for example in the form of a reference number, batch number or the like (see also question 2).
Further to posting warnings about dangerous products, the manufacturer must generally give the consumer the information necessary to estimate the risk of using the product. This information can be given in the form of warnings, instruction manuals, information in the store, and such like. It is not important how this information is conveyed, but that it is conveyed in an appropriate manner considering the circumstances.
Are there requirements or guidelines for the content of recall notices?
The DSTA has not issued its own guidelines. However, the DSTA refers to the Corrective Action Guide, issued by a group of organisations through the EMARS project and funded by the European Commission, which contain guidelines and suggestions on how a recall notice should be drafted. This guide can be found on the DSTA’s website (www.sik.dk), but are non-binding and can be deviated from if another procedure is considered to be at least as effective.
Generally a recall notice should:
- be at least one A4 page;
- have a heading containing the Danish word for ‘warning’ or ‘xx manufacturer warns’ and which tells what kind of product is involved and the problem the notice concerns;
- contain a photo of the product (minimum half an A4 page) that represents the product in as identifiable a way as possible; and
- be short, informative and precise, and say something about the problem, the danger, how to react, where to get more information and the date of the notice.
What media must be used to publish or otherwise communicate warnings or recalls to users or suppliers?
Information about recalled products will be made available at www.sik.dk. Even after a successful recall, the products can be found in an archive on the DSTA’s website with information about the product.
Regarding advertisements in the media, there is no list of media that should be used. The actual media to be used will be the result of a dialogue between the DSTA and the manufacturer and will be based upon the manufacturer’s knowledge of the sale of the product and how to most effectively reach the consumers affected. It is, however, the manufacturer’s responsibility to ensure that all consumers are reached.
If the parties cannot come to terms, the DSTA will as a minimum require that the notice is advertised in national media.
Do laws, regulation or guidelines specify targets or a period after which a recall is deemed to be satisfactory?
No targets and no specific time period exist after which a recall is deemed to be satisfactory. The DSTA will, however, usually follow up on recalls and if the circumstances of the case prove to be unsatisfactory, the manufacturer must take new steps to secure a satisfactory recall.
Repair and replacement
Must a producer or other supplier repair or replace recalled products, or offer other compensation?
An obligation to repair or replace the product cannot be inferred from the Product Safety Act.
The Danish Sale of Goods Act governs the obligations of the manufacturer and distributor to repair or replace the goods. An unsafe product is generally considered to be non-conforming and will entitle non-consumers to avoid the contract, claim a proportionate price reduction or, in some cases, claim damages.
Consumers can demand repair, redelivery of a conforming product, a price reduction or they can avoid the contract. If the seller offers to repair or deliver a conforming substitute product, the buyer cannot avoid the contract or demand a price reduction. Further to this, the buyer cannot claim redelivery or a repair of the product if this is impossible or imposes disproportionate costs on the seller. The rules regarding consumers cannot be derogated from in a negative manner, while the buyer and seller in non-consumer contracts can make alternative arrangements.
According to the Danish Sale of Goods Act, a notice of must generally be given within reasonable time and ultimately within a two-year period of the goods being handed over to the buyer. However, in situations where a public authority has issued an injunction to recall or destroy a product (not withdraw), the time bar is not applicable, and the rules in the Danish Statute of Limitations will apply instead. The point in time at which the non-conformity claim becomes statute-barred will then depend on the actual circumstances, but can be as long as 10 years.
If a recall is completed voluntarily, the two-year time bar will probably still apply and will thus limit the sellers’ liability for goods.
What are the penalties for failure to undertake a recall or other corrective actions?
See question 3.
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?
If the manufacturer or the distributor fail to take actions or the actions taken prove to be insufficient, the authorities can issue an injunction against a manufacturer, or someone who has been involved in marketing or selling the product, to warn the consumer, remedy the circumstances that have resulted in the danger, or to destroy, withdraw or recall the product, etc.
The authorities are able to take the above-mentioned measures themselves and thereby, to a certain extent, act on behalf of the person who introduced the dangerous product on the market. This possibility exists if that person does not take the necessary steps himself or herself, including taking due actions, or does not follow a ban or an injunction from the authorities. Before the authorities resort to such measures, they must make an assessment of which measures are necessary to use in the actual case.
In situations where it is not possible to trace the person who introduced the product on the market, the authorities may also act on behalf of this person and can post warnings, destroy the product, secure a recall or a withdrawal and so on.
Can the government authorities publish warnings or other information to users or suppliers?
The authorities have the competence to issue warnings, complete recalls and withdrawals, among others, regarding specific products if the person who introduced the product onto the market fails to take appropriate measures or where it is not possible to trace the person who introduced the product onto the market. To the extent that the relevant authority becomes aware of a general problem regarding a specific type of product, it may post warnings, safety guidelines and such like on its website in a general attempt to prevent accidents relating to a specific product group. There is, however, no official website where members of the public can post remarks or reports of incidents, but it is always possible for a member of the public to notify the authorities of a specific problem or finding.
Upon receiving such reports, the authorities will act upon it when relevant and may initiate recall, withdrawal or warning proceedings according to the procedures described in this chapter.
Several authorities will publish lists of recalled products on their website and also store them in an online archive for a period of time.
Can the government authorities organise a product recall where a producer or other responsible party has not already done so?
See question 19.
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?
If the authorities organise a product recall according to the Product Safety Act, the costs incurred by the authorities can be recovered from the party on behalf of whom the authority is acting.
How may decisions of the authorities be challenged?
As a general rule the decisions made by the authorities according to the Product Safety Act cannot be challenged to a higher administrative authority. Authorities overseeing sector-specific regulation can, however, also use the Product Safety Act to issue injunctions and such like and the relevant minister has the authority to issue general rules regarding the possibility of challenging sector-specific decisions. Some sector-specific rules give the option to challenge decisions according to the relevant law.
According to the Product Safety Act, if the authorities have issued a ban or an injunction according to specific provisions of the Product Safety Act, the addressee can demand to have the ban or injunction tried by the courts if he or she makes a request to the relevant authority within three months after being informed of such. If the addressee makes such a request, the authority will then have the ban or injunction tried by the courts without undue delay. The court can decide that a request suspends the ban or injunction.
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?
It seems highly plausible that the courts will see a safety warning as an admission of the product being defective, and if the plaintiff can prove that there has been an injury caused by the defect, this will in most cases result in liability.
Can communications, internal reports, investigations into defects or planned corrective actions be disclosed through court discovery processes to claimants in product liability actions?
It is possible that information sent to the authorities can be disclosed to the public.
According to the Product Safety Act, the authorities must, when possible, disclose information to the public about the risk related to dangerous products, the measures taken in an actual case, how to identify the product, how the consumer should act, etc. The authorities may, however, only disclose commercially sensitive information if this is necessary to protect the health and safety of the consumer.
Furthermore, it is possible to request information from public authorities, but the access to such information does, as a general rule, not include commercially sensitive material. If a document or the like contains both commercially sensitive and non-sensitive information, access can be given to the non-sensitive information (see also question 10).
When product liability actions are tried by the Danish civil courts, the Danish civil procedural law applies. However, the procedural law rules do not provide for court discovery processes as known in common law countries, and the principle of proceedings is therefore applicable. This means, as a general rule, that no party is compelled to disclose certain information or documents. It is, however, possible for the court to direct that the opposing party or a third party provide certain information upon request. In addition to this, information as described may be disclosed due to the authorities’ obligation according to the Product Safety Act to release information about the risk related to dangerous products, the measures taken in an actual case, how to identify the product, how the consumer should act and such like (see also question 10).
Updates and trends
Updates and trends
Updates and trends
The DSTA monitors and investigates the market for defective and unsafe products in Denmark and the authorities have constant and significant focus on the market for electronic devices and toys. Investigations carried out by the DSTA have recently resulted in a series of product recalls within these particular business sectors. In order to help businesses in general (ie, not only electronic and toy businesses) to comply with applicable product safety regulation, and hence avoid defective and unsafe products being placed on the market, the Market Surveillance Council has launched a guidance website. This website lists the relevant rules for a wide range of product categories that products must comply with and the relevant public authorities for the products concerned. The website can be found at www.virk.dk.
Moreover, the Danish parliament has recently enacted a new Gas Safety Act and five associated executive orders that seek to modernise and simplify the rules and requirements concerning gas installations, plants and equipment. A novel feature is that the executive orders contain certain minimum safety standards as opposed to detailed product specific requirements that businesses must comply with. The aim is to give businesses as much freedom as possible as to how they wish to comply with applicable law without putting the general security level at risk.