Reporting requirements for defective productsGovernment notification
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.Competent authority
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.Pharmaceuticals
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.Notification information
What product information and other data should be provided in the notification to the competent authority?
The information requested reflects Appendix I to Directive 2001/95/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.Penalties
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.Public disclosure
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.