How to sell food supplements in Sweden and Finland

1. Check that it really is a food supplement

In both countries a food supplement is a food, not a medicine. It is regulated by food law, with extra rules for supplements: in Sweden the Swedish Food Agency’s regulations LIVSFS 2023:3, and in Finland the Decree on Food Supplements 78/2010. If the product, its name or its marketing suggests that it prevents, treats or cures a disease, it can be classified as a medicine, which is a different and much heavier route (in Sweden, Läkemedelsverket).

Neither authority approves a supplement in advance. The company that places it on the market is responsible for showing that it is safe and compliant.

2. Ingredients and doses

• Only the vitamins and minerals, and the forms of them, listed in the EU Food Supplements Directive 2002/46/EC may be used.
• For other substances, such as plant extracts, there is no complete positive list. You must be able to show that each ingredient is safe, is not a medicine and is not an unauthorised novel food.
• Prepare a technical file per product: full formula, dose per daily portion, certificates of analysis and the specification of each ingredient. A Nordic distributor will usually ask for it before listing the product.

3. Labelling and claims

On top of the general EU food labelling rules (Regulation 1169/2011), Swedish rules require supplements to carry:

• the name “kosttillskott”;
• the names of the nutrients or substances that characterise the product;
• the recommended daily dose and a warning not to exceed it;
• a statement that supplements should not replace a varied diet;
• a statement to keep the product out of reach of young children;
• the amount of each nutrient or substance per daily dose, with vitamins and minerals as a percentage of the reference values.

The information must be in Swedish. In Finland the label model you file must be in Finnish and Swedish. Health claims are allowed only if they are authorised under Regulation 1924/2006 and listed in the EU Register of nutrition and health claims, and medical claims are never allowed. Labels and marketing that were written for Portugal or another country usually need rewriting, not just translating.

4. Sweden: who registers what

A business that sells food supplements in Sweden, in a shop or online, must register its activity with the municipality where it operates, at the latest two weeks before it starts. The municipality then becomes its food control authority. Handling or repacking supplements made from animal ingredients, such as fish oil capsules, requires approval from the Swedish Food Agency.

In practice this means your Swedish importer or distributor carries the registration and the day-to-day responsibility, and will check your label, claims and technical file carefully before taking the product.

5. Finland: the notification

Finland adds a step that Sweden does not ask for in this form: every operator that manufactures, imports or otherwise places a food supplement on the Finnish market, including through a web shop, must notify the Finnish Food Authority (Ruokavirasto), at the latest when the product goes on sale. The mandatory attachment is a clear model of the Finnish and Swedish label. A new notification is needed when the composition of the characterising substances changes, when the brand name changes or when another operator becomes responsible. Each responsible operator, for example each importer, files its own notification.

Ruokavirasto charges a handling fee: 68 euros for a notification through its e-service and 136 euros by post or email. Receiving the notification does not mean the product has been approved.

6. Choosing the first market and partner

1. Pick one market first. Sweden is the larger market and the usual entry point; Finland can follow with the same Swedish-language work plus Finnish labelling and the notification.
2. Pick the channel: pharmacy chains, health-food stores or online. Each expects different margins, proof and marketing support.
3. Have the review done before you contact distributors: ingredients, doses, claims and a Swedish label draft per product. Distributors move faster when the compliance work is already done.
4. Then shortlist distributors that already sell comparable supplements in your channel, and approach them with the technical file, the label draft and a clear reason why your product sells.

This guide is general information, not legal advice. Check each product with the authority or a regulatory specialist before you place it on the market.