In Finland, food supplements are regulated as food products instead of medicines. Instead of pre-market registration or authorisation, the authorities require submission of notification. This notification should be submitted at the same time as the product is placed on the market or when the composition is changed.
Submission of notification doesn’t mean the authority approves its legal compliance. So, food business operators, manufacturers, and importers need to understand the intricacies of food supplement regulation in Finland. This guide covers it in detail.
Regulatory Authority for Food Supplements in Finland
Food supplements are regulated by the Finnish Food Authority (Ruokavirasto) in Finland. The principal national framework is the Finnish Ministry of Agriculture and Forestry’s Decree 78/2010 on Food Supplements, which implements EU Directive 2002/46/EC.
Pre-market authorisation isn’t compulsory here. The authority only receives food supplement notifications and provides national guidance on their regulatory requirements.
Also, compliance does not sit entirely with Ruokavirasto. Food businesses are subject to control by municipal food control authorities, which receive notification information for supervision. The Finnish Food Authority states that food supplement notifications are forwarded to the authority supervising the company. Customs control the import of products into Finland.
What Are Food Supplements Under Finnish Regulations?
It’s a packaged food that’s prepared in advance. It contains a concentrated source of nutrients or other substances that have a nutritional or physiological effect. These supplements add to the existing diets of individuals. Companies can’t show their intention of the product as a substitute for varied diets.. Also, these products don’t provide a lot of energy.
Food supplements are packed in small/measured dosage forms. Their form can be capsules, tablets, lozenges, pills, powders, drops, or liquid. They are preparations for the intake of vitamins, minerals, fibre, fatty acids, bees, plants, and algae.
Regulations & Controls Applicable to Food Supplements in Finland
Finnish national rules and EU legislation both apply to food supplements in Finland.
| Finnish Legislation | EU Legislation | Control over Food Supplements |
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Food Supplements Notification Process in Finland
Since food supplements, considered as food products, don’t need any authorisation for their marketing, their labelling or composition is not assessed before reaching the market. The food business operator has to check the legality and safety of their product before placement on the market. However, they do have to notify the Finnish Food Authority.
The notification should be submitted at the latest at the same time as placing a product on the market. It should also be submitted when the composition and its characteristic substances change. For that, the following process has to be followed:
Step 1: Confirm Product Classification
Make sure the product complies with the definition of a food supplement in the country. It should not be defined as a medicinal product.
Step 2: Verify the Composition & Novel Food Status
Check the formulation against applicable requirements. If the product contains an ingredient that’s not sure of or has a limited history of consumption in the EU, its important to assess its novel-food status before market entry.
Step 3: Review the Finnish & Swedish Label
Both Finnish and Swedish languages should be used for labels and given regulations should be followed.
Step 4: Prepare the Notification
Write the notification and add product information, information about the business, and a copy of the product label in Finnish/Swedish/English to it.
Step 5: 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. can also mail the notification form with attachments to the Registry office.
Step 6: Pay the Applicable Fee
Pay the appropriate notification fee according to the notification method.
Step 7: Market the Product
In case of any further changes in the product, inform the Finnish Food Authority.
Documents Required for Food Supplements Notification Process 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).
Food Supplement Notification 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.
Food Supplement Notification 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.
Compliance Checklist for Food Supplement in Finland
When considering marketing a food supplement product in the country, 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.
Finnish Labelling Requirements for Food 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 product name, description of nutrients or substances in the product, recommended intake, ingredients list, net quantity, and information about the food business operator. There should also be the following mandatory warnings:
- 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.
Need expert help with labelling compliance? Experts at Artixio can make it simpler for you.
GMP Requirements for Food Supplements in Finland
The manufacturers of food 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
Food Claims and Advertising Regulations in Finland
In accordance with the EU Nutrition and Food Claims Regulation (EC) No. 1924/2006, food supplements are required to meet the standards of that regulation. Health claims should only be used where they have been authorised and are included in the applicable lists of permitted claims. So, companies must check the claims they make in product packaging, websites, e-commerce listings, social media, advertisements, and promotional materials.
The claims should have a scientific backing. They must not turn a food supplement into a product marketed as a medicine. The control guidance specifically states that supplement marketing claims should be truthful and not medicinal.
Import Regulations for Food Supplements in Finland
Imported food 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 classification & compliance
- Submitting the notification
- Verifying Finnish and Swedish labelling
- Maintaining compliance documentation
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 food 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 in Finnish or Swedish?
Yes. In Finland, all food supplements need to be labelled both in Finnish and Swedish.
Who must submit a food supplement notification?
The notification obligation applies to a food business operator that:
- Manufactures a food supplement
- Has a food supplement manufactured
- Imports a food supplement
- Otherwise, place the food supplement on the Finnish market.
