United States Mission to the European Union
Foreign Agricultural Service
United States Department Of Agriculture
Last modified: February 14, 2018

Dietetic foods

Dietetic or special use foods

EU requirements applicable since July 20, 2016

In June 2013, the EU adopted Regulation 609/2013 which completely overhauls the current dietetic food rules.  The scope of this new regulation is limited to infant formula and follow-on formula, processed cereal-based food and baby food, food for special medical purposes and total diet replacement for weight control.  Regulation 609/2013 applies as of July 20, 2016, and repeals the general rules on “Foods for Particular Nutritional Uses” currently set out in Directive 2009/39/EC, as well as the complementing directives and regulations 96/8/EC (energy-restricted diets), 1999/21/EC (special medical purposes), 2006/125/EC (processed cereal-based foods and baby foods), 2006/14/EC (infant and follow-on formula) and 953/2009 (substances that may be added to dietetic foods) and 41/2009 (gluten-free foods).

Foods that no longer fall within the scope of Regulation 609/2013 will be regarded either as regular foods regulated under the “Food Information to Consumers” Regulation 1169/2011 or as fortified foods regulation under Regulation 1625/2006.  Foods that carry a nutrition or health claim will have to comply with the EU’s Nutrition and Health Claims Regulation 1294/2006.


Harmonized compositional and labeling rules for foods for persons with gluten intolerance were previously set out in Directive 41/2009.  With the adoption of the new dietetic foods Regulation 609/2013, it was decided that gluten-free foods would be regulated under the “Food Information to Consumers” Regulation 1169/2011Commission Delegated Regulation 1155/2013 amended Regulation 1169/2011 to include the provisions relating to the absence or reduced presence of gluten in food.  Commission Implementing Regulation 828/2014, applicable as of July 20, 2016, sets out conditions for using “gluten-free” and “very low gluten” statements on food labels.