1 Introduction
Public authority action shall be based on legislative competence conferred to the authority and be consistent with legislation. Authoritative guidelines are not, by their legal nature, binding on other authorities or operators. Issues pertaining to the application of legislative regulations are in the last instance settled by a court of law.
These guidelines present both direct quotations from legislation and interpretations on the application of legislation. Legislative text is clearly distinguished from the rest of the text. The interpretations presented in these Guidelines constitute Finnish Food Authority's views on how legislative regulations should be applied.
2 Legislation
Food supplements refer to pre-packed products in the form of a briquette, capsule, pastille, tablet, pill, powder, concentrate, extract or liquid, or in some other equivalent dose form, marketed as foodstuffs to be consumed in measured small doses whereby the amount of energy received has no relevance to the diet as a whole (Decree on Food Supplements 78/2010, Section 2).
Legislation providing for food supplements:
- Decree of the Ministry of Agriculture and Forestry on food supplements (78/2010, hereunder the Food Supplements Decree).
- Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements (hereunder the Food Supplement Directive).
- Regulation (EC) No. 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (hereunder the Fortification Regulation).
- Annex I Vitamins and minerals which may be added to foods
- Annex II Vitamin formulations and mineral substances which may be added to foods
- Annex III Substances whose use in foods is prohibited, restricted or under community scrutiny
- Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (hereunder the Food Information Regulation)
- Regulation (EC) No. 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods (hereunder the Health Claim Regulation).
- Food Act (297/2021)
EC legislation can be accessed at EUR-Lex-database and national legislation can be accessed at Finlex-database.
Other guidance concerning food supplements:
- Food Supplement Guide, Evira Guide 17012/5
3 Notification obligation
Under Decree 78/2010 of the Ministry of Agriculture and Forestry on Food Supplements a commercial operator who produces or imports a food supplement or has a food supplement produced with a view of placing it on the Finnish market shall submit a written notification to the Finnish Food Authority. A notification shall also be submitted in case the composition of the product is changed with respect to the substances that characterize it.
Under Food Act 297/2021 6 § the obligation for notification applies also to food business operators who place food supplements on the market in other ways (for example via web shop).
The regulations do not specify when the food supplement notification is to be submitted, but it should be done before the food supplement is placed on the market in order to enable effective control.
If there are several operators with responsibility for the food supplement (e.g. several importers), each shall submit the food supplement notification. A new notification shall be submitted whenever the operator who produces or imports the product or has it produced or in some other manner is responsible for placing the product on the market changes. A change in the commercial product name, the so-called brand name, also requires that the notification be submitted, even if the composition of the food supplement remains unchanged.
3.1 Submitting a notification
Notification is submitted either through the Finnish Food Authority’s electronic service or by post.
A fee is charged for the processing of food supplement notifications that pertain to the placing of the product on the market or to the changing of the composition as stipulated in the Decision of the Ministry of Agriculture and Forestry on the fees charged for services produced by the Finnish Food Authority. A higher fee is charged for a notification received by post because it takes longer to process than notification received through the electronic service.
3.1.1 The Finnish Food Authority’s electronic service
The notification of placing a food supplement on the market or of a change in the composition is submitted via Finnish Food Authority's electronic service. The e-forms are available in Finnish, Swedish and English. The electronic service system is logged in on Finnish Food Authority's website.
Select in the electronic service the “Notification of food supplement” and then select from the “Type of notification” dropdown list the notification of placing a food supplement on the market or of a change in the composition of food supplement.
“The notification of a change in the composition” is selected, when the composition of the food supplement is to be changed with respect to the substances that characterize it. The date as of which the change in the composition of the product will be valid shall be indicated in the notification.
The different package sizes of the same product can also be included in the same notification if the composition of the products is exactly the same. On the other hand, different alternative flavours are different products and a separate notification is necessary.
The notifications of changes in the composition of food supplement can be specified to pertain to a food supplement of which a notification has been made previously ("Product being notified"). The dropdown list only shows food supplements of which notifications have been submitted via the electronic service. If the food product to which the notification pertains is not included in the list, select "Not found” in the list.
When the notification has been successfully submitted, the Finnish Food Authority sends the operator a reply message to the email address indicated in the notification.
More detailed instructions for the use of the Finnish Food Authority's electronic service can be found under the "Help" button in the top bar on the electronic service page, or on the Finnish Food Authority's website.
3.1.2 Notifications submitted outside electronic service
Food business operators who for some reason cannot submit notifications via the electronic service can fill in the notification on Finnish Food Authority's website.
Notifications that are not submitted via the electronic service shall be sent to Finnish Food Authority’s Registry
- by post to Finnish Food Authority / Registry: P.O. Box 200, FI-00027 FINNISH FOOD AUTHORITY or
- by email to kirjaamo@ruokavirasto.fi.
Receipt of notification submitted by post takes place in the same way as through the electronic service. An acknowledgment of receipt will be sent by email to the address given by the food business operator. A higher fee is charged for a notification received on a notification form because it takes longer to process than the notification received through the electronic service.
3.2 Processing notifications at the Finnish Food Authority
The Finnish Food Authority considers the notification obligation to be fulfilled when the notification, including all the required information and attachments, is received by the Finnish Food Authority. A model of the product labelling, presented in a clearly and legible form, is a mandatory attachment to the notification. The Finnish Food Authority can ask the operator to supplement the notification later.
The Finnish Food Authority does not evaluate the regulatory compliance of the composition or package labelling of the food supplement on the basis of the notification.
Furthermore, receipt of the notification does not imply that the Finnish Food Authority would have approved the product as being in compliance with food regulations.
The food business operator is responsible for ensuring that the food supplement notified is in conformance with the legislation applicable to it. This also requires the food business operator to carry out an own-check as provided by the Food Act. The operator must have a system in place to enable it to ensure that the product is in conformance with the relevant requirements of food legislation.
The information and attachments of the notification received are sent to the municipal food control authority for information and control purposes. In addition, the Finnish Food Authority may, if necessary, send information to other supervisory authorities, e.g. the customs authorities.
4 Information on food supplement
In addition to the information referred to in the Food Supplements Decree, the notification form is designed for the gathering of the information referred to in the Food Information Regulation.
More information about labelling requirements pertaining to food supplements and the application of the requirements is provided in the Food Information Guide (17068/2) and in the Food Supplement Guide (17012/5).
These Guides can be found in electronic form on the website of the Finnish Food Authority’s website.
4.1 Commercial name of food supplement
The commercial name refers to the so-called brand name of the product, under which the food supplement is marketed, e.g. "Vitamix".
4.2 Name of food
The name of the food indicates in a concise and precise form what the food package contains, e.g. a vitamin product, a plant extract preparation or a fish oil capsule.
The name specified in the legislation of the European Community shall be used for the food, or in the absence of such a name, the name stipulated for use in Finland. If no such name has been stipulated, the established name used in Finland shall be used or a name that describes the food, and if necessary, its use in such a manner that the name specifies the food explicitly and distinguishes it from foods with which it could otherwise be confused.
The name of the food must not be confused with its commercial product name or brand name. Commercial names and brand names are voluntary information in the labelling and do not replace the name of the food.
In addition to the name of the food, the labelling of a food supplement shall also include the marking "food supplement". Finnish Food Authority recommends that this marking is placed near the name of the food.
4.3 Country of origin
The labelling of origin refers to an indication made in the labelling of the food or in some other manner of the country or region of origin of the food. In practice, the country of origin is often the country in which the food is produced.
The country or region of origin shall be indicated if its absence could mislead the consumer as concerns the origin of the food.
4.4 Category of characteristic ingredients of food supplement or indication of the nature of these nutrients
The names of the categories in which the nutrients or other substances that are characteristic ingredients of the food supplement or an indication of the nature of such nutrients or substances shall be shown in the labelling of the product (Decree on Food Supplements 78/2010, Section 5).
The category refers to the group in which the characteristic ingredient of the food supplement can be classified. Categories include e.g. vitamins, minerals, fibres, amino acids, fatty acids as well as plant and herbal extracts. Food supplements can be classified in several categories, if they contain characteristic ingredients of different categories. The number of lines can be increased in the e-form according to the number of categories in which the food supplement is considered to be included.
If the dropdown list in the electronic service does not include a suitable category for the characteristic ingredient, it can be classified to category "other" and provide more detailed information about the nature of the substance under "Other information".
4.5 Purpose of use and target group
The target group for which the food supplement is designed.
4.6 List of ingredients
The list of ingredients lists the ingredients used in the production of the food. The ingredients of the food are listed in full in descending order of weight at the time of production. Reference to the attached labelling model alone is not adequate.
4.7 Recommended daily dose
Pursuant to Section 5 of the Decree on Food Supplements, the daily dose of the food supplement recommended by the producer shall be indicated in the labelling of the product, e.g. 2 tablets twice a day.
4.8 Quantity of content
The quantity of content refers to the quantity of the food in the package at the time of packing, e.g. 220 g, 60 pcs. The time of packing refers to the time when the product is ready to be marketed. The weight of packaging may not be included in the indicated quantity of content. The quantity of content shall be expressed with units commonly used in Finland for solid foods. For liquid products, the quantity of content shall be expressed with units of weight or volume commonly used in Finland. Additionally, the labelling can indicate the number of items or the number of doses.
4.9 Characteristic substances of food supplement and their amount in the daily dose
Characteristic substances of food supplement refer to nutrients, such as vitamins or minerals, or some other substances with a nutritional or physiological effect.
Characteristic substances refer to the substances with which the product is marketed, such as vitamin C, omega-3 fatty acid, chamomile extract, or Lactobacillus acidophilus bacteria.
Each characteristic substance is entered in the e-form as a specific item. The selection of “+ Add characteristic substance” opens a field with a dropdown list from which the characteristic substance is selected. The substance can either be directly selected from the dropdown list “Select the characteristic substance” or substances can be filtered by first clicking “Select the class of the substance”.
Plants used as characteristic substances can also be filled in the form under their scientific name by choosing “Show plant’s scientific name”. It is recommended that also the part of the plant that has been used is indicated. If the part of the plant is not included in the dropdown list, it can be added under "Other information". If the substance is a plant, the form of the substance is also selected from the dropdown list, e.g. powder or extract.
In case of vitamins and minerals the form in which the vitamin or mineral has been added can be selected from the "Chemical compound used" dropdown list. The dropdown list contains only the chemical compounds, which can be used in food supplements.
If the characteristic substance is not included in the list, its name can be entered in the empty field by selecting "If you cannot find the substance in the list, open here".
A warning appears on the e-form if the other substance entered is e.g. a novel food or a medicinal substance. More information can be obtained by clicking on the warning. However, a warning does not prevent the notification from being sent.
The amounts of the characteristic substances of the food supplement shall be entered in the empty field “Amount of characteristic substances in daily dose”. If the recommended daily dose of the food supplement is given in range, for example 1-2 tablets, the amount shall be entered according to the highest daily dose. For vitamins and minerals, the e-form system automatically adds the correct unit to the amount and calculates the proportion of the vitamin/mineral of the reference value for daily intake. For other characteristic substances the correct unit is chosen from the “Unit” dropdown list.
The characteristic substance can be deleted from the form by choosing “Delete characteristic substance”.
4.10 Additional information
Additional information can be provided on the food supplement, if considered necessary, such as
- alcohol content
- minimum storage time
- storage instructions
- warnings under the Food Supplement Decree or other possible warnings in the labelling of the food supplement
- other instructions of use
Information can be given also on any nutrition or health claims concerning the characteristic substances of the food supplement.
More information about nutrition and health claims is provided on the Finnish Food Authority's website.
In additional information the company can also inform of special wishes related to the invoicing the reception of the notification. For example, if the company wishes that a special identification number is added to the invoice.
5 Attachments
The model of the labelling
The notification shall be accompanied by a model of the labelling of the food, indicating both regulatory and voluntary labelling, and if possible, also the planned illustrations for the package. The labelling model shall be clear and easy to read.
Power of Attorney
If the signatory/signatories of the notification are not authorised to sign the company name, a Power of Attorney shall also be attached to the notification.
Other attachments
Other attachments to the notification may include e.g. a product brochure.
6 Other considerations
Food business operators are responsible for the compliance of their products with the provisions on food supplements and other regulations on foods.
Questions related to food and food labelling can be directed to municipal food control authorities. More information about food supplements is also available on Finnish Food Authority's website.
Questions, reports of malfunctions or problems, and comments about the Finnish Food Authority's electronic service may be emailed to elintarvikeilmoitukset@ruokavirasto.fi.
7 Coming into force
This guidance has come into force on 1.6.2021 and it replaces the previous version (The Finnish Food Safety Authority Evira’s guidance 17006/3, published on 30.9.2013).