Guide/version: 6540/04.02.00.01/2021/8
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 the Finnish Food Authority’s
views on how legislative regulations should be applied.
2 Legislation
Fortification of food refers to the adding of nutrients, most commonly one or several vitamins and/or minerals, to food in connection with the production process.
Relevant legislation providing for fortified foods:
- 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 (hereafter the Fortified Food 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
- The Decree (726/2007) of the Ministry of Trade and Industry on the national measures required by the entry into force of 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
- Commission implementing regulation (EU) No. 307/2012 establishing implementing rules for the application of Article 8 of 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
- Decree (754/2016) of the Ministry of Agriculture and Forestry on adding vitamin D to fat free milk
- Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (hereafter the Consumer Information Regulation)
- Regulation (EC) No. 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods (hereafter the Health Claim Regulation)
- Food Act (297/2021).
EU legislation can be found in the EUR-Lex database and national legislation in the Finlex database.
More information:
- Guidelines for Control of fortified foods (The Finnish Food Authority’s guideline
6538/04.02.00.01/2021) - Guidelines for withdrawal of fortified foods (The Finnish Food Authority’s
guideline 6539/04.02.00.01/2021).
3 Notification obligation
Under Decree (726/2007) of the Ministry of Trade and Industry a food business operator who produces or imports a food fortified with vitamins and/or minerals or has such a food produced shall submit a written notification to the Finnish Food Authority.
The fortification notification is required of foodstuffs that are fortified in themselves. The notification is also required, when the composition of a food changes with respect to the added vitamins and/or minerals or when the foodstuff is removed from the market. The notification is not required, on the other hand, of foodstuffs containing a fortified food as an ingredient.
The regulations do not specify when the fortification notification is to be submitted, but it should be done before the food is placed on the market in order to enable effective control.
If there are several operators with responsibility for the food, e.g. several importers, each shall submit the fortification 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 fortified food remains unchanged. In this case a notification of the removal of the product from the market shall be made on the food with the old composition.
3.1 Making a notification
Notification is made either through the Finnish Food Authority's electronic service or by post.
A fee is charged for the processing of notifications that pertain to the placing of the product on the market or to the changing of the composition as stipulated in the Ministry of Agriculture and Forestry Decree (161/2021) on charges for services performed by the Finnish Food Authority. No fee is charged for notifications of the removal of products from the market. 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 fortified food on the market, of a change in the composition or of removal from the market is submitted via the Finnish Food Authority's electronic service. The e-forms are available in Finnish, Swedish and English. The electronic service system is logged in on the Finnish Food Authority's website.
Select in the electronic service the "Notification of a fortified food" and then select from the "Type of notification" dropdown list the notification of placing a fortified foodstuff on the market or of a change in the composition of fortified foodstuff.
“The notification of a change in the composition” is selected, when the composition of the fortified food is to be changed with respect to the added vitamins or minerals. The date as of which the change in the composition of the product will be valid shall be indicated in the notification. A notification need not be submitted of removal from the market of the food with the old composition.
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 "Notification of removal from the market" is selected, when submitting a notification of the removal of a fortified food from the market. It is recommended that the notification of the removal of the food from the market be submitted, when information about the removal of the product from the market is available. The notification shall indicate the date on which the product is removed from the market, e.g. before the best before date of the last batch.
The notifications of changes in the composition or removal from market of fortified foods can be specified to pertain to a fortified food of which a notification has been made previously ("Product being notified"). The dropdown list only shows fortified foods 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 Notification submitted outside electronic service
Food business operators who for some reason cannot submit notifications via the electronic service can fill in the notification on the Finnish Food Authority's website.
Notifications made without the electronic service must be sent to the Finnish Food Authority's Registry
- by post to Finnish Food Authority / Registry, PL 200, 00027 RUOKAVIRASTO 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 notification received through the electronic service.
Notifications of a change in the composition of a fortified food can only be submitted via the electronic service. Otherwise the fortified food product with changed composition with respect to vitamins or minerals is considered to be a new product and a new notification shall be submitted of it. A notification of removal from the market shall be submitted of the product with the old composition.
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 labelling of the fortified food product, 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 product 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 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 foodstuff regulations. The operator must have a system in place to enable it to ensure that the product is in conformance with the relevant requirements of foodstuff legislation.
The information and attachments of the notification received are sent to the municipal food control authority and the Regional State Administration Agency for information and monitoring purposes. In addition, the Finnish Food Authority may, if necessary, send information to other supervisory authorities, e.g. the customs authorities.
4 Information on fortified food
In addition to the information referred to in the Fortified Food Regulation, the notification form is designed for the gathering of the information referred to in in the Food Information Regulation.
More information about requirements pertaining to the fortification of food is provided in the Guidelines for Control of fortified foods (The Finnish Food Authority’s guideline 6538/04.02/00.01/2021).
4.1 Commercial name
The commercial name (e.g. ”Namis”) refers to the so-called brand name of the product.
4.2 Name of foodstuff
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.
More information in Guidelines on Food Information published by the The Finnish Food Authority.
4.3 Food group, food class and food product
Foods are in the e-form divided into food groups and food categories to facilitate the search for foods.
The food groups and classes are based on the FoodEx2 draft of the European Food Safety Authority EFSA. As the objective of EFSA's system has been to gather the food products most commonly used in the EU countries, it may be difficult to find there some foods generally included in the Finnish food culture or eating habits, or equivalent products. The Finnish Food Authority can be informed of any fortified foods not found in the list.
The food group in which the fortified food is included is first selected from the "Food group" dropdown list, e.g. "Fruit and vegetable juices and nectars".
The food classes are determined by the food group selected in the e-form. The proper food class is selected from a dropdown list. For example, food group "Fruit and vegetable juices and nectars" includes the food classes “Fruit juices” as well as “Mixed fruit and
vegetable juices or nectars”.
The foods included in the "Food product" dropdown list of the e-form are determined by the selected food class. For example, if the selected food class is “Fruit juices”, the "Food product" dropdown list includes e.g. orange juice and black currant juice.
4.4 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.
4.5 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.
4.6 The product has been fortified in the sense of Regulation 1925/2006 with the following vitamins and minerals
Each vitamin and mineral used to fortify the food is entered in the e-form as a specific item. The selection of "+ Add vitamin/mineral" opens a field with a dropdown list from which the added vitamin/mineral is selected. The form in which the vitamin or mineral has been added can be selected from the "Chemical compound used" dropdown list. If the food has been fortified with several vitamins or minerals, information is entered on each of them by selecting "+ Add vitamin/mineral" and filling in the information.
The amounts of the vitamins and minerals added in the food are entered in the e-form under "Nutrient declaration". Both fields shall be filled in carefully with respect to all the vitamins and minerals added in the food.
4.7 Nutrition declaration
Nutrition declaration must be presented according to the Food Information Regulation. Nutrition declaration is compulsory on fortified foods.
In the electronic service, the operator selects if the nutritional content of the food is indicated per 100 grams (solid food) or 100 millilitres (liquid food). The e-form contains entry fields for the energy content of the food as well as for the amounts of fat, saturated fat, carbohydrates, sugars, protein and salt per 100 g or 100 ml of the product. It is also possible to provide voluntary nutritional information, e.g. regarding dietary fibre.
The amounts of all the added vitamins and minerals shall be entered. Each new vitamin/mineral is entered in the e-form by first pressing the "+" button and then selecting the added vitamin/mineral from the dropdown list and entering its amount. The e-form system automatically adds the correct unit to the amount and calculates the proportion of the added vitamin/mineral of the reference value for daily intake.
Also other substances added in the food can be entered in the e-form, in addition to vitamins and minerals. The "+" button is pressed first, and then the other substance is selected from the dropdown list. The substance can either be directly selected from the dropdown list or substances can be filtered by first selecting the class of the substance. If the 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". If the substance is a plant, the form of the substance is also selected from the dropdown list, e.g. powder or extract. The amount of the substance is entered per 100g or 100 ml and the correct unit is selected from the dropdown list.
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.
Nutritional information can be provided of a food ready for consumption, if adequately detailed instructions for preparation are provided in the labelling and the information pertains to the food prepared according to these instructions. For example, it would be informative to indicate in the labelling of a juice concentrate that needs to be diluted the nutritional content of the juice when it is ready for consumption. If the nutritional information refers to food that is ready for consumption, this shall be indicated in e.g. the "Additional information" field of the e-form.
4.8 Additional information
Additional information can be provided on the fortified food, if considered necessary, such as information on any nutrition claims regarding the adding of a vitamin or mineral (e.g. "Vitamin C added") according to the Claim Regulation, or on any warnings (e.g. "Not recommended for pregnant women") or instructions for use (e.g. "No more than 5 cans a day").
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
Model of 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 Contact information
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 15.11.2021 and it replaces the previous version (The Finnish Food Safety Authority’s guidance 17002/7, published on 19.12.2019).
Updates in version 8
The guide has corrections to references to legislation (Finnish Food Act 297/2021 and Ministry of Agriculture and Forestry Decree 161/2021 on charges for services performed by the Finnish Food Authority) and to the updated Food Authority’s guidelines.