Questions about food supplements

1. How do I know that Evira really has assessed the product and it is safe? Does Evira assess food supplements before they may be introduced into the Finnish market?

– Evira does not assess food supplements before they are introduced into the Finnish market and no advance authorisation from Evira is required for food supplements.

A food supplement notification must be submitted to Evira, however, of a new food supplement about to be entered into the market. This notification is submitted by the manufacturer or the importer or the company for which the product is manufactured. Evira must also be notified if the marketing of the food supplement is discontinued or the importer changes or the substances that characterise the product are modified. E vira receives the notification but does not assess the safety, composition or labelling of the product.

The pertinent operator in the food sector, i.e. the manufacturer, importer or corresponding operator is responsible for the food supplement being safe to the consumer.

Food supplememt notification

2. I purchased a food supplement but I am not sure if it is safe to use. Who can I contact?

– The pertinent operator in the food sector, 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.

Evira has prepared instructions to consumers for the safe use of food supplements. Evira also recommends that persons 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.

Food supplement

Feedback on food

3. A food supplement contains several herbs, 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 web site.

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:314:0036:0042:FI:PDF
Novel foods 
http://www.fimea.fi/laakehaut_ja_luettelot/

4. 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.

There are no provisions regarding the minimum amounts of vitamins and minerals, but in Evira's opinion it is misleading to refer in the marketing of a food supplement to vitamins or minerals, if their content per daily dose is less than 15% of the EU reference value for daily intake.

5. 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 and in the Labelling Guide.

Labelling 

6. What requirements must operators selling food supplements fulfil by law?

- Operators who sell food supplements shall submit a food establishment notification on the facility in which food supplements are handled, stored or sold. The notification is submitted to the municipal food control authorities. The food establishment notification is also required on online stores selling food supplement, even if the operator has no actual physical facilities. The notification then pertains to a virtual establishment.

The operator shall have an in-house control plan in place, indicating that the operator is aware of 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 Evira.

7. I am planning to start the import of food supplements. Who can I contact for advice?

– Evira's web site provides an abundance of information on e.g. food establishment approval, the notification procedure for food supplements as well as labelling.

The food control authorities (health inspector) in each municipality advise food sector operators and consumers. Companies providing consulting services related to food supplement notifications and labelling can be contacted, if necessary.

Food establishments

8. Can the product be sold even if the receipt of the food supplement notification has not been acknowledged by Evira? 


– Yes. Evira 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 Evira.
Evira 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 Evira would have accepted the declared food supplement as being in conformance with food regulations.
The individual 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.

9. 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 Evira?

– Evira 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.

10. 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 forbidden.

http://www.fimea.fi/laakehaut_ja_luettelot/