Notification of placing a foodstuff for particular nutritional use on the market

When a foodstuff for particular nutritional use is placed on the market for the first time within the European Economic Area in Finland, the manufacturer or the importer shall make a notification of this to the Finnish Food Safety Authority.  

However, a notification is not required for the following foodstuffs for particular nutritional uses:

  1. Infant formulae and follow-on formulae
  2. Baby foods
  3. Part of the foods for weight reduction (total diet replacement and meal replacement)
  4. Dietary foods for special medical purposes as a rule (cf. exception below *)
  5. Foodstuffs for special nutritional uses for sportsmen
  6. Foods for persons suffering from carbohydrate-metabolism disorders (diabetes)

A notification shall be made of all other foodstuffs for special nutritional uses than the ones listed above. These include e.g.

  1. Low-lactose and lactose-free milk products
  2. Gluten-free foods
  3. Low-sodium foods, including low-sodium or sodium-free dietary salts
  4. * Dietary foods for special medical purposes manufactured in Finland or outside the European Economic Area when the product is placed for the first time on the market in Finland
  5. Other foodstuffs that meet the criteria foodstuffs for particular nutritional uses, such as products designed for persons suffering from high blood cholesterol
  6. Foods for weight reduction other than the above mentioned

The notification is made using a special notification form and it shall be accompanied by a model of the label. Where the same product is subsequently placed on the market in another Member State the manufacturer or the importer shall provide the competent authority of that Member State with the same information, together with an indication of the recipient of the first notification. The Finnish Food Safety Authority will confirm the reception of the notification of a foodstuff for particular nutritional use by a letter. As stipulated in the Food Act the food operator is responsible for the conformity of the product to the decree on foodstuffs for particular nutritional uses and to other decrees on foodstuffs. This does not apply to notifications regarding foods for special medical purposes manufactured in Finland or outside the European Economic Area. These notifications are processed, the conformity of the product to law is evaluated and the decision of the Finnish Food Safety Authority is sent to the food operator.

Where a foodstuff for particular nutritional use has been placed on the market for the first time within the European Economic Area in some other country than Finland, and at that time a notification has been made to the competent authority of the Member State in question, the Finnish Food Safety Authority shall be provided with the information of the reception of the first notification as well as of the contents of the notification when the product is placed on the market in Finland. The product shall be notified in Finland by using the afore mentioned notification form. A copy of the reply received from the competent authority of the Member State where the product has been put on the EU market for the first time must be enclosed.

Fee for notification

The fee for the reception of a notification of a foodstuff for particular nutritional use is 28 euros. Decision of the Ministry of Agriculture and Forestry on the fees charged for the services produced by the Finnish Food Safety Authority Evira (266/2008).

For the processing of a notification of dietary foods for special medical purposes (products manufactured in Finland or outside the European Economic Area and placed on the market for the first time in Finland) and for the decision made on the notification, a fee based on an price (68 euros) is charged.

 

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