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Foods for specific groups

 

Food for specific groups are EU-regulated and have to comply with Regulation (609/2013) on Food for Specific Groups.
The regulation aims to protect specific vulnerable groups of consumers (infants and young children, people with specific medical conditions and people undertaking energy-restricted diets to lose weight) by regulating the content and marketing of food products specifically created for and marketed to them. It also aims to increase legal clarity for business and to facilitate correct application of the rules.
Under the Regulation there are four categories of ‘special’ foods:

  • Infant formula and follow-on formula
  • Processed cereal-based food and baby food
  • Food for special medical purposes
  • Total diet replacement for weight control

In Denmark, there is no national legislation for these products except temporarily for VLCD products (see below).

 
Notification 
Food for special medical purposes, infant formulae and certain follow-up formulae must be notified when placing the product on the market. This means that the company (EU manufacturer, EU importer or the company responsible for marketing in Denmark) is required to send a copy of the label as well as the name and address of the company to the Danish Veterinary and Food Administration (DVFA).
The notification has to be send via e-mail to notifikation@fvst.dk
The company will receive an automatic receipt. The receipt is not an approval of the product. It is the company’s responsibility that the product complies with the legislation.
The DVFA can make decisions concerning the product's label, marketing and composition based on inspection.
VLCD products (Very low energy diets for weight reduction with an energy intake below 800 kcal)
Until 27 October 2022 the addition of nutrients to VLCD-products needs to be notified to or approved by the DVFA before marketing the product according to the Danish legislation on fortified food.
 
Instructions on the process can be found in our guide on fortified food
 
From 27 October 2022 VLCD products cannot be marketed since the level of energy will be too low in many products. The products will no longer be covered by the Danish legislation on fortified food. Either the VLCD products must be removed from the market or they must be reformulated in order to comply with the rules on total diet replacements.
 
Legislation regarding food for specific groups. 

Regulation (609/2013) on Food for Specific Groups.

 

Infant formula and follow-on formula

Commission delegated regulation (EU) 2016/127 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 infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding

Commission directive 2006/141/EF of 22 December 2006 on infant formulae and follow-on formulae

Executive Order no. 97 of 29 January 2020 on infant formula and follow-up formula based on hydrolised protein

 

Processed cereal-based food and baby food

Commission directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children

Executive Order no. 99 of 29 January 2020 on processed cereal-bases foods and babyfoods for infants and young children

 

Food for special medical purposes

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   

Commission Notice on the classification of Food for Special Medical Purposes (2017/C 401/01)

 

Total diet replacement for weight control

Commission delegated regulation (EU) 2017/1798 of 2 June 2017 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 (The regulation can be used on a voluntarily basis).

Commission directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight control

Executive Order no. 590 of 24 May 2017 on foods intended for use on energy-restricted diets for weight control

 

VLCD products

Codex standard for VLCD products for use in very low energy diets for weight control

Scientific Opinion on the essential composition of total diet replacements for weight control

Executive Order no. 1236 of 28 November 2019 on the addition of vitamins and minerals to food

 
Last Modified 22. April 2020