In addition to EU legislation, marketing a health supplement in Finland must also meet the requirements for notification, labelling, and food supplements in Finland. Businesses must inform the Finnish Food Authority and comply with the Finnish labelling rules before they can launch the product to the market.
This guide covers the health supplement registration process, compliance, labelling, import obligations, market entry timelines, and costs for Finland.
Regulatory Authority for Health Supplements in Finland
Health supplements are regulated by the Finnish Food Authority (Ruokavirasto) in Finland. It is responsible for food supplement notifications, regulatory guidance, and food market surveillance with municipal food control authorities.
Compliance with Finnish and EU food legislation is a continuous responsibility of businesses.
What Are Health Supplements Under Finnish Regulations?
In Finnish legislation, a health supplement is a packaged food, prepared in advance, and contains a concentrated source of nutrients or other substances that have a nutritional or physiological effect.
It should be packaged in measured dosage forms like capsules, tablets, powders, drops, or liquid and should be used as an addition to the normal diet.
Compliance Checklist for Health Supplement Approval in Finland
When considering marketing a health supplement product in Finland, you should:
- Check if the product is a food supplement.
- Check that ingredients meet EU regulations and are not illegal novel foods or drugs.
- Make compliant labels in Finnish and Swedish.
- Notify the Finnish Food Authority of the food supplement.
- Maintain documentation demonstrating product safety.
- Maintain technical records which are readily available to view.
Health Supplements Registration Process in Finland
A food supplement notification is required before it can be marketed in Finland. Below is the step-by-step notification process.
Step 1: Confirm Product Classification
Make sure the product complies with the definition of a food supplement and that it is not defined as a medicinal product or novel food.
Step 2: Verify Product Compliance
Confirm compliance of ingredients, nutrition and health claims, and labelling in accordance with the Finnish and EU regulations.
Step 3: Prepare the Notification
Write the notification containing product information, information about the business, and a copy of the product label (Finnish/Swedish).
Step 4: Submit the Notification
Send the notification using the Finnish Food Authority’s Electronic Food Notifications Service on Suomi.fi authentication. Foreign businesses that are not able to access the portal can submit the official notification form via email or mail.
Step 5: Pay the Applicable Fee
Pay the appropriate notification fee according to the notification method.
Step 6: Market the Product
The product can be sold after the notification is made. In case of any further changes in the product, inform the Finnish Food Authority.
Documents Required for Health Supplements Registration in Finland
The notification should contain:
- A notification form and/or online notification
- The product name and composition.
- Information on food business operators.
- The product label (required) is in Finnish and Swedish.
- Power of attorney (if applicable).
Finnish Labelling Requirements for Health Supplements
The labels have to meet the EU Food Information Regulation and the requirements of food supplements set by the Finnish authorities. All products sold in Finland must be written in Finnish and Swedish.
Mandatory information includes:
- Name of the product (Food Supplement)
- Describe nutrient or other substances
- Recommended daily dose
- Caution: Do not exceed the recommended daily dose!
- Supplements shouldn’t be a substitute for a balanced diet.
- Please keep out of reach of young children.
- Ingredient list, net quantity and information about the food business operator.
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Licensing Requirements for Health Supplements in Finland
There is no product licence requirement for health supplements in Finland. Rather, businesses have to provide a food supplement notification prior to marketing.
Businesses must:
- Register to be a food business operator (if applicable)
- Submit a notification for each food supplement
- Inform the Finnish Food Authority about major changes in the product
GMP Requirements for Health Supplements in Finland
The manufacturers of health supplements are subject to EU legislation on food hygiene and are required to have HACCP-based food safety procedures in place. While the certification to pharmaceutical GMP is not compulsory, manufacturers should keep:
- Quality control procedures
- The tracking of all ingredients and batches
- Production records
- Hygiene controls
- Product recall procedures
Health Claims and Advertising Regulations in Finland
In accordance with the EU Nutrition and Health Claims Regulation (EC) No. 1924/2006, health supplements are required to meet the standards of that regulation. A list of approved nutrition and health claims is applicable.
Health supplements cannot:
- To claim to cure, prevent, or treat diseases
- Deceive consumers as to product benefits
- Assess a balanced diet as being insufficient
Import Regulations for Health Supplements in Finland
Imported health supplements will have to meet the requirements of Finnish and EU food law. Importers are required to notify the authorities about food supplements prior to marketing.
The importers’ obligations include:
- Ensuring product compliance
- Submitting the notification
- Verifying Finnish and Swedish labelling
- Maintaining compliance documentation
Health Supplement Registration Timelines in Finland
Since food supplements are not subject to pre-market approval, there is no registration time period specified in Finland.
The time it will take to enter the market will largely be determined by:
- Product classification
- Checking ingredients and labels
- Notification preparation
- Any requests for further information are made.
Health Supplement Registration Costs in Finland
The Finnish Food Authority’s fee is:
- €68 for electronic notifications
- Notifications by e-mail/post: €136
- If a notification is incomplete or withdrawn, this fee will be half the amount.
Other costs may involve label translation, regulatory review, product testing and compliance support.
Conclusion
Businesses have to fill out the notification and meet food supplement and labelling requirements before marketing the products; pre-market approval is not required in Finland.
Artixio helps businesses classify products, notify food supplements, label products, and provide end-to-end regulatory compliance to ensure successful market entry in Finland. Reach out to us at info@artixio.com to talk about your regulatory needs.
FAQs
Do health supplements need to be approved before they can be sold in Finland?
No. Finland uses a notification system, and businesses are required to notify the authorities about the food supplement prior to marketing.
Who is responsible for providing the food supplement notification?
The food business operator who is going to make the product available in the market in Finland, e.g. the manufacturer or importer.
Is it possible for foreign companies to make a notification for a food supplement?
Yes. If they are not able to use the electronic notification service in Finland, they can submit the official notification form by email or mail.
Do you have to send a notification for each product?
Yes. Usually, a notification for each product is needed. Pack size notification may apply to multiple different pack sizes of the same composition.
Do labels have to be Finnish or Swedish?
Yes. In Finland, all health supplements need to be labelled both in Finnish and Swedish.
