Guide/version 2396/04.02.00.01/2020/2, valid from 14.12.2022
1 Introduction
An authority's actions must be based on the powers granted to it by legislation and laws must be strictly adhered to in activities performed by an authority. By their legal nature, instructions issued by authorities are not binding on other authorities or actors. Issues concerning the application of legislation are ultimately settled in a court of law.
These guidelines tell you how to make the notification for infant formulae, some follow-on formulae, foods for special medical purposes and total diet replacements for weight control. The guidelines contain both direct quotes from legislation and interpretations of the application of the legislation. Legislation is clearly separated from the rest of the text. The interpretations given in these guidelines are the views of the Finnish Food Authority about how the legislation should be applied.
2 Legislation
The common framework legislation for foods for specific groups is:
- Regulation (EU) No 609/2013 of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.
Provisions on infant formulae and follow-on formulae:
- Commission Delegated Regulation (EU) 2016/127 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding.
Provisions on foods for special medical purposes:
- Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for foods for special medical purposes.
Provisions on total diet replacements for weight control:
- Commission Delegated Regulation (EU) 2017/1798 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control.
EU legislation can be found in the EUR-Lex database.
3 Definitions
Infant formulae, follow-on formulae, foods for special medical purposes and total diet replacements for weight control are included under foods for specific groups.
Infant formula means food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding.
Follow-on formula means food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants.
Food for special medical purposes means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients
- with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or
- with other medically-determined nutrient requirements, and
- whose dietary management cannot be achieved by modification of the normal diet alone.
Total diet replacement for weight control means food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet.
Other foods for specific groups are processed cereal-based foods and other baby foods.
4 Notification requirement
Food business operators must make a notification to the Food Authority of the placing on the market of the following foods for specific groups:
- Infant formulae
- Follow-on formulae in the following cases:
- follow-on formulae manufactured from protein hydrolysates
- follow-on formulae containing substances other than those listed in Annex II to Commission Delegated Regulation (EU) 2016/127
- Food for special medical purposes
- Total diet replacement for weight control.
A model of the product label and where appropriate a power of attorney must be attached to the notification.
4.1 Legal basis for notifications
Follow-on formulae manufactured from protein hydrolysates or containing substances other than those listed in Annex II:
- Article 12 of (EU) 2016/127
Food for special medical purposes:
- Article 9 of (EU) 2016/128
Total diet replacement for weight control:
- Article 7 of (EU) 2017/1798.
The Food Authority holds that where several food business operators, for example several importers, are responsible for a food, each operator who places the food on the market shall submit a notification for the food concerned. A new notification must be submitted whenever there is a major change in the composition of the product or when there is a change in the manufacturer, company for which the food is manufactured, importer or other party who places the product on the market. Notification must be made also as regards a change in the commercial name of a food (brand name), even if the composition of the food remains unchanged.
4.2 Making a notification
Notification is made either through the Finnish Food Authority's electronic service or by post.
A fee is charged for the receipt of notification as provided by the Decree 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.
If a company has particular requests, such as the addition of a particular code to the invoice, in respect of the fee charged for receipt of the notification, requests must be emailed to the email address for food notifications elintarvikeilmoitukset@ruokavirasto.fi. The message must clearly itemise the products that the request concerns.
4.2.1 Notification made through the Finnish Food Authority's electronic service
Notification of the placing on the market of infant formulae, some follow-on formulae, foods for special medical purposes or total diet replacements for weight control can be made through the Food Authority’s electronic service, where electronic notification forms can be found in Finnish, Swedish and English. Logging in to the electronic service is via the Food Authority website using a suomi.fi e-authorisation. The authorisations required to log on to the electronic service can be requested as instructed on the suomi.fi website.
In the electronic service, choose "Notification on foods for special medical purposes" and the "Type of notification" form from the menu depending on whether the notification concerns the placing on the market of an infant formula, follow-on formula, a food for special medical purposes or a total diet replacement for weight control.
The same notification can be used to indicate different packaging sizes for the same product, provided that the composition of the products is exactly the same. However, different flavours are different products and separate notification is required for each flavour.
Once the notification has been successfully sent, the food business operator will receive a reply message from the Finnish Food Authority to the email address given in the notification.
Detailed instructions on how to use the Finnish Food Authority's electronic service can be found behind the "Instructions" button on the top bar of the electronic service.
4.2.2 Notification made without using the electronic service
If the food business operator, for one reason or another, is unable to submit the notification through the electronic service, the notification can be made by filling in the notification form 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 100, 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.
4.3 Processing notifications at the Finnish Food Authority
The Finnish Food Authority considers the notification requirement to have been met once the notification, including all the necessary information and attachments, has been received by the Authority. The mandatory attachment is a model of the label in Finnish and Swedish, and which must be clear and legible, also in electronic format. The Food Authority may request the food business operator to supplement the notification at a later date if the information provided is incomplete or unclear.
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.
The information and attachments in the notification received are sent to the municipal food authority for information and control purposes. In addition, the Food Authority may, where appropriate, send information to other food control authorities.
5 Information about the food to be notified
In addition to the information required by the delegated regulations, the notification form also collects mandatory food information under the Food Information Regulation. The mandatory information to be provided in the electronic form is highlighted in yellow.
5.1 Commercial product name
Commercial product name means the brand name of the product.
5.2 Name of the food
The name of the food must be the name laid down in legislation of the European Community or, in the absence thereof, the name laid down for use in Finland. If there is no such name, the name of the food must be the established name generally used in Finland or a name that describes the food and, if necessary, its use so as to accurately identify the food in question and distinguish it from foods with which it could otherwise be confused.
The name of the infant formula and follow-on formula must comply with the names set out in Commission Delegated Regulation (EU) 2016/127 which are “infant formula” or “infant milk” and “follow-on formula” or “follow-on milk”. The names may be supplemented with words describing the state of the formula (e.g. powdered) or its use (e.g. ready for use).
The name of foods for special medical purposes is set out in Article 4 and Annex IV of Commission Delegated Regulation EU) 2016/128 and which is “food for special medical purposes”. In Finland, the product may also be called a clinical nutrient supplement. The names may be supplemented with words describing the formula or its use.
A total diet replacement for weight control must be sold under this name as required under Article 2(1) of Commission Delegated Regulation (EU) 2017/1798.
5.3 Food group, food category and food item
The electronic form classifies foods into food groups and food categories to make the food search easier. The grouping and classification of food has been adapted from the EFSA FoodEx2 classification system of the European Food Safety Authority.
First choose the food group to which the product belongs in the menu. For foods for a specific groups, the food group is “Food for specific groups”.
The food categories are determined based on the food group selected in the electronic form. Choose the appropriate food category, for example “liquid infant formula”, “food for special medical purposes” or “total diet replacement for weight control”.
The foods in the food menu on the electronic form are defined based on the food category chosen. The food selection groups for infant formulae and follow-on formulae are chosen according to the protein source of the formula, which are: cows' milk and goats' milk protein, protein hydrolysates or soya protein isolates. The foods on the food menu for foods for special medical purposes are nutritionally complete or nutritionally incomplete. The alternatives in the food menu for total diet replacements for weight control are very low energy content and low energy content.
5.4 Country of origin
Country of origin labelling means indicating, on the packaging or otherwise, the country or region of origin that the food comes from. In practice, country of origin means the country in which the food is manufactured.
5.5 List of ingredients
The list of ingredients tells which ingredients were used to make the food. The ingredients of a food are listed in descending order by weight at the time of manufacture. All the ingredients must be entered, a simple reference to the accompanying labelling is not enough.
5.6 Nutrition labelling
Information on nutritional composition is declared for each product ready for use.
Infant formulae
The energy content of infant formula and follow-on formula is expressed per 100 ml of the food ready for use after preparation in accordance with the manufacturer’s instructions. However, the amounts of nutrients such as fat, carbohydrate, protein, vitamins and minerals are expressed per energy amount of the prepared food. Whether nutrition information is expressed per 100 kJ or 100 kcal is notified by choosing the right alternative at the start of nutrition labelling on the form.
Each vitamin and mineral added to the product is declared in a separate section on the electronic form. Selection of “+ Add vitamin/mineral” will open a field with a picklist from which the vitamin/mineral selected is added. The chemical compound in the form of which the vitamin or mineral has been added to the food can be selected from the “Chemical compound used” picklist. If the food is supplemented with more than one vitamin or mineral, re-select "+ Add vitamin/mineral" and complete the information. The sections must be carefully completed for all added vitamins and minerals. The amounts of vitamins and minerals are expressed in terms of the amount of energy of the product either per 100 kJ or 100 kcal.
The electronic form may also be used to declare the addition of a nutrient or substance other than a vitamin or a mineral to a food. Other substance is added by pressing the "+" button, and then selecting the substance from the menu. A substance may be selected straight from the menu or substances may be filtered by first selecting the substance category. If the substance is not on the list, the name of the substance can be entered in the empty field by selecting "If the substance is not on the list, open here". The amount of other substance is also given in terms of amount of energy either per 100 kJ or 100 kcal. This point is mandatory when providing notification of the placing on the market of a follow-on formula containing substances other than those listed in Annex II.
Foods for special medical purposes
The vitamin and/or mineral to be declared in the electronic form is added in the same way as for infant formula. The amounts of vitamins and minerals are expressed, however, in terms of the amount of energy in the product either per 100 kJ or 100 kcal.
The vitamin and/or mineral to be declared in the electronic form is added in the same way as in the form for infant formula and follow-on formula. The amounts of vitamins and minerals are expressed, however, in terms of the amount of energy in the product i.e. per 100 kJ or 100 kcal.
Those substances which it is necessary to declare for the appropriate intended use of the product are declared under Other nutrients or substances. The amount of these substances is also expressed per 100 kJ or 100 kcal.
Total diet replacements for weight control
The amounts of energy, fat, carbohydrate, protein, salt and choline in total diet replacements for weight control are expressed both per individual portion or consumption unit and per total daily ration. The amount of dietary fibre is also declared where this has been added to the product. The size of each individual portion and how many portions constitute the total daily ration must also be indicated on the form.
Vitamin and minerals are declared in the same way as on the notification form for infant formulae and follow-on formulae. Information about the amounts of vitamins and minerals are expressed per individual portion and per total daily ration. It is also possible on the form to declare the addition of other substances.
5.7 More information
More information such as any warning labels or instruction for use can be added in the additional information field where this is considered necessary.
6 Attachments
Model of the label
A model of the Finnish and Swedish label of the food showing both mandatory and voluntary marking and, where possible, images designed for the packaging must be attached to the notification. The label must be clear and legible. If the model of the label provided with the notification is unclear or difficult to read or the file cannot be opened, the Finnish Food Authority will request the notifier to submit a new model of the label.
Power of attorney
If the signatory/signatories of the notification do not have the right to write the business name, a power of attorney must also be attached.
Other attachments
Other attachments that may accompany the notification include, for example, a product brochure.
7 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.
8 Updates in version 2
- Notifications concerning certain follow-on formulae and total diet replacements for weight control have been added to this version.