As required by a new EU Regulation, a notification on the market entry of all dietary foods for special medical purposes must be submitted to the Finnish Food Authority. The Regulation also prohibits the inclusion of nutrition or health claims on packaging and in advertisements.
Food for special medical purposes is intended as a partial replacement or as a supplement to a patient’s diet. Such products include dietary foods for patients with feeding tubes or infant formulas for infants who are allergic to cows milk.
The Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes becomes enforceable on 22 February 2019. The Regulation will apply to food for special medical purposes for infants as of 22 February 2020.
Food businesses are responsible for regulatory compliance
All dietary foods for special medical purposes entered on the market must be declared to the Finnish Food Authority with a notification form; later, the notifications can also be submitted electronically. The Finnish Food Authority does not assess the products’ compliance with the regulations when the notification is received. The food business placing the product on the market will be responsible for assessing regulatory compliance. The Finnish Food Authority forwards the notifications to the relevant food control authorities of municipalities and Customs, who are in charge of the control of food products. The fee charged by the Finnish Food Authority for notifications on food for special medical purposes is EUR 81.
Businesses may continue to sell their remaining inventories of products manufactured and labelled in accordance with the repealed provisions.
Inclusion of nutrition or health claims on packaging and in advertisements becomes prohibited
Dietary food for special medical purposes is intended for the feeding of patients with a disease, disorder or medical condition due to which their nutrient requirements are impossible or very difficult to manage with other foodstuffs. Dietary foods for special medical purposes are to be used under medical supervision.
Dietary foods for special medical purposes may only be sold in packages in which the name of the disease, disorder or other medically-determined nutrient requirement is indicated as follows: “Dietary food for managing ....”. This sentence must be completed by adding the name of the disease, disorder or medical condition for the dietary management of which the food for special medical purposes is intended.
Nutrition or health claims may no longer be presented on dietary food for special medical purposes. No description of the properties and/or characteristics that make the product useful in relation to the disease, disorder or medical condition for the dietary management of which the product is intended, or any implication that the product could have such properties and/or characteristics, may not be attached to dietary food for special medical purposes.
For more information, please contact:
Anna Lemström, Senior Officer, Ministry of Agriculture and Forestry, tel. +358 (0)50 502 0414, firstname.lastname(at)mmm.fi (Legislation)
Sari Sippola, Senior Officer, Finnish Food Authority, tel. +358 (0)50 386 8430, firstname.lastname(at)ruokavirasto.fi (Notifications on food for special medical purposes)