1. How do I know that really has assessed the product and it is safe? Does Finnish Food Authority assess food supplements before they may be introduced into the Finnish market?
– Finnish Food Authority does not assess food supplements before they are introduced into the Finnish market and no advance authorisation from Finnish Food Authority is required for food supplements.
A food supplement notification must be submitted to Finnish Food Authority, however, of a new food supplement about to be entered into the market. This notification is submitted by the food business operator who manufactures, has a food supplement manufactured, imports, or otherwise places on the Finnish market a food supplement. Finnish Food Authority must also be notified if the importer changes or the substances that characterise the product are modified. Finnish Food Authority receives the notification but does not assess the safety, composition or labelling of the product.The Finnish Food Authority forwards the food supplement notifications for information to the authority supervising the company.
The manufacturer, manufacturer, importer or seller is responsible for the safety of the food supplement to the consumer. The company is also responsible for providing sufficient and correct information about the product. It is the responsibility of the company, under its own control, to ensure, if necessary through analysis, that the composition of the product conforms to the information given on the label. Municipal food control authorities monitor the implementation of own-check by companies and, if deficiencies are found, take control measures.
More information about food supplement notification
2. Is it legal to order a food supplement from abroad for private use, e.g. on the internet?
– The laws do not restrict the ordering of food supplements from abroad for private use.
It is advisable, however, to check from the list maintained by the Finnish Medicines Agency that the product does not contain any substances classified in Finland as medicinal products. The receipt by post of medicinal products from a country outside the European Economic Area is prohibited.
More information on Fimea's website.
Customs instructions ordering goods from online for the customer
3. I purchased a food supplement but I am not sure if it is safe to use. Who can I contact?
– The food business operator, i.e. the manufacturer or the importer or the company, which markets the product or for which the product is manufactured is responsible for the food supplement being safe to the consumer. The operator is also responsible for withdrawing from the market a product found to be defective or suspected to have adverse effects on health, and for informing consumers about this.
Finnish Food Authority has prepared instructions to consumers for the safe use of food supplements. Finnish Food Authority also recommends that persons belonging to vulnerable consumer groups, such as those suffering from a long-term illness, such as a cardiovascular disease, consult their doctor about the use of food supplements.
Consumers can file a complaint, if necessary, to the food control authorities (health inspector) of their own municipality.
Advice for consumers on the use of food supplements
Where can you complaints about defective food? (contact information)
4. A food supplement contains several herbal extracts, vitamins and other substances. Is there a list of approved substances that may be used in food supplements?
– There is no list of prohibited or approved substances, except for vitamins and minerals and their sources. The main rule is that the product must be safe for use as food, its ingredients shall have a history of use and the ingredients must not make the product a medicinal product. The operator is responsible for verifying that the product meets these requirements.
The Finnish Medicines Agency Fimea maintains a list of the substances and herbals that may make a product a medicinal product. Vitamin and mineral products intended for children can also be classified as medicinal products. More information about classification can be found on Fimea's website.
Vitamins and minerals allowed in food supplements and their sources (2002/46/EC)
More information on history of consumption and novel foods
5. Are there minimum and maximum limits for vitamins and minerals contained in a food supplement? Or for other substances, such as e.g. herbal extracts?
– There are no national regulations on maximum amounts. However, the product must be safe when consumed according to the instructions for use. The European Commission is currently preparing a proposal for the maximum amounts of vitamins and minerals in food supplements (and in fortified foodstuffs).
Moreover, products for which the content of vitamins or minerals is extremely high per daily dose can be classified as medicinal products by the Finnish Medicines Agency. Each product is classified separately.
The Claims Regulation (1924/2006/EC) regulates when a food, such as a food supplement, can be marketed as a source of vitamins and minerals. In order for a food supplement to be sold as a source of vitamin and/or mineral, and for a vitamin/mineral to be labelled as a characteristic substance of a food supplement, the amount of vitamin/mineral in a daily dose must be at least 15% of the daily reference intake value (1169/2011/EU).
6. What is required of the labelling of food supplements?
– The general labelling requirements applied to other foods also apply to food supplements. Labelling must be provided in both Finnish and Swedish.
The labelling of a food supplement shall also indicate the nutrients that characterise the product, the portion of the product recommended for daily consumption and the following warning notices:
- The recommended daily dose must not be exceeded.
- The food supplement shall not be used as a substitute for a varied diet.
- The product shall be stored out of the reach of young children.
More information about labelling is provided in the Food Supplement Guide.
7. What requirements must operators selling food supplements fulfil by law?
- Operators who sell food supplements must submit a notification of their food business to the municipal food control authority. The notification is also required on online stores selling food supplement, even if the operator has no actual physical facilities. In this case, it is a distance selling in a so-called virtual establishment.
The operator shall have an own-check in place, which allows the operator to control the risk factors related to foods.
The operator selling a food supplement should also verify from the operator who has produced or imported the product or had it produced that a food supplement notification on the marketed products has been submitted to Finnish Food Authority.
More information on registering a food business
8. I am planning to start the import of food supplements. Who can I contact for advice?
– Finnish Food Authority's web site provides an abundance of information on e.g. food business registration, the notification procedure for food supplements as well as labelling.
The food control authorities (health inspector) in each municipality advise food business operators and consumers. Companies providing consulting services related to food supplement notifications and labelling can be contacted, if necessary.
More information on registering a food business
Instructions and legislation for food business operators
Contact food control authorities
9. Can the product be sold even if the receipt of the food supplement notification has not been acknowledged by Finnish Food Authority?
– Yes. Finnish Food Authority considers the obligation to submit a notification fulfilled when the notification has been successfully submitted via the electronic service, or when a notification filed without using the service, complete with all the required information and enclosures, is received at Finnish Food Authority.
Finnish Food Authority does not evaluate the safety, composition or labelling of the product when the notification is received. Consequently, the receipt of the notification does not mean that Finnish Food Authority would have accepted the declared food supplement as being in conformance with food regulations.
The party who submitted the notification will receive a message acknowledging the receipt of the notification. The notification complete with enclosures will also be forwarded for information and control purposes to the local food control authorities and, where necessary, to other control authorities as well.
10. I am planning to export a food supplement and need for this purpose an export certificate or equivalent indicating that the product is authorised for marketing in Finland. Can I obtain such a certificate from Finnish Food Authority?
– Finnish Food Authority does not issue export certificates or statements or any other export documents of this type. The operator should contact the municipal food control authorities for such documents.
Contact food control authorities