On 12 June 2013, the EU Parliament adopted Regulation 609/2013 (“Regulation”) which sets out the composition and labelling requirements for food intended for infants and young children, food for special medical purposes and total diet replacements for weight control. Collectively these are known as “food for specific groups”.

This is a consolidating piece of legislation and aims to both simplify and clarify the labelling and composition requirements of foods which came to be known as “Foodstuffs for Particular Nutritional Uses” (“PARNUTS”). As well as the requirements set out in the Regulation, “food for specific groups” still need to comply with other relevant food legislation.


Directive 2009/39/EC (“PARNUTS Framework Directive”) set out the general labelling and product safety rules for dietetic foods. A number of further Directives focusing on specific PARNUTS were introduced including: Directive 2006/141/EC on infant formula and follow on formula; Directive 2006/125/EC on processed cereal based foods and baby foods for infants and young children; and Directive 1999/21/EC on dietary foods for special medical purposes. The Regulation will gradually repeal these directives and at the end of the transition period will come into force from 20 July 2016.


The Regulation covers four categories of food:

  1. infant formula and follow-on formula;
  2. processed cereal based food and baby food;
  3. food for special medical purposes; and
  4. total diet replacements for weight control.

Food falling into these categories can only be placed on the market if they are in compliance with the requirements of the Regulation which include:

  • the composition of the food must be appropriate to satisfy the nutritional requirements of the intended consumer;
  • the food should not contain any substance which would harm the health of the intended consumer; and
  • only the use of vitamins and minerals included on the list in the Annex to the Regulation (known as the “Union List”) can be added to the food.

As stated above, the Regulation will apply from 20 July 2016. However Articles 11, 16, 18 and 19 have been in force since 19 July 2013. These articles give the Commission powers to adopt further changes to the requirements of the food covered by the Regulation. For example, further requirements in relation to the composition of the food covered by the Regulation and further labelling and advertising rules.

The Regulation also states that by 20 July 2015, the Commission will produce reports covering food intended for “sportspeople” and milk-based drinks for young children which will consider the need for special provisions needed for these products and where necessary, the publishing of draft legislation.