A food supplement is a food that meets all of the following conditions:
- is intended for supplement the normal diet (not providing significant energy);
- is a concentrated source of certain substances, such as vitamins, minerals, caffeine, plant extracts;
- is intended for use in small doses or at fixed doses and therefore are marketed as capsules, pastilles, tablets, powder sachets, ampoules, drip bottles or other similar forms;
- is marketed in sales packaging.
Food supplements are e.g. vitamin D tablets, omega-3 fish oil or lactic acid bacteria capsules.
- Database for notified food supplements
- Classification of products by the Agency of Medicines
- List of plants with medicinal properties
- The European Commission
- European Food Safety Authority (EFSA)
- EU Register of nutrition and health claims made on foods
- Novel food catalogue
- Food Supplements Europe Guides
Food supplements that are placed on the Estonian market for the first time must be notified to the Agriculture and Food Board.
The following information must be sent for notification:
- product and company information;
- date of marketing;
- example(s) of labelling.
An example of the labelling is all the information on the sales package (text and pictures, symbols, etc).
Example of labelling shall be sent in such a way that all information on the labelling is visible and readable.
Examples of labelling must be provided in Estonian as well as in the original language (unless the original packaging of the product is already in Estonian).
Without labelling sample(s), the product cannot be considered as notified.
Notifications can be sent:
- via Internet (Ministry of Rural Affairs Customer Portal);
- by e-mail to firstname.lastname@example.org;
- by post to address Väike-Paala 3, Harjumaa, Tallinn 11415.
Notification shall be made no later than the day on which the food supplement is placed on the market.
The notification is free of charge. If food supplements are controlled after notification, supervision fee will be charged (23,84 € per hour).
1. Notification is not required if product is already notified by other company. It can be checked from notified food supplement database
2. Notification is not required for different package sizes of the same product (e.g. 30 tablets and 60 tablets)
3. New notification is required if following data changes: food supplements name, brand's name, manufacturer's name and/or country of origin. New notification is not required if the name of the notifier's company changes
5. When product contains medical herbs, please contact Agency of Medicines for classification
6. Please make sure that notification documents contain information about full Latin names of plants used in product
Product notified via e-mail or by post, will be added to database within one week after receiving all the necessary documents. Food supplements notified via internet go automatically to the database.
Agriculture and Food Board does not send confirmation letter about the notification unless it is required by company.
The notification is not a declaration by the Agriculture and Food Board of the conformity of the product. Notification gives the legal right to market the food supplements in Estonia. Food manufacturers, distributors are responsible for the safety and conformity of food supplements.
Food business operators are responsible for ensuring that food supplements are safe and compliant. The following is an overview of the requirements for food supplements:
- there is no national list of substances authorised/prohibited in food supplements in Estonia;
- products, containing plants with medicinal properties and classified as medicine by the Agency of Medicines, are prohibited;
- maximum levels for vitamins and minerals are based on EFSA’s tolerable upper intake levels;
- only specific substances can be used as vitamins and minerals;
- products may not contain unauthorized novel foods;
- only authorized nutrition and health claims can be used. For plants, pending health claims can be used;
- the labelling of food supplements is subject to general food labelling requirements, special requirements for food supplements and, if necessary, labelling requirements for novel foods;
- only certain food additives can be used in accordance with the food additives regulation;
- no microbiological criteria for food supplements have been established. Maximum levels have been set for certain contaminants.
Food supplements production/packaging requires an approval from the Agriculture and Food Board.
Marketing, intermediation and production in private houses must be notified to the Agriculture and Food Board.
All approved and notified companies can be found here.
There are no specific requirements for the handling of food supplements and therefore general requirements apply, like:
- ensuring traceability of products;
- compile a self-control plan;
- informing the Agriculture and Food Board of dangerous food that has entered the market.
Last updated: 12.05.2021