The information below provides an overview of the current regulation for specialist nutrition products

Regulation (EU) No 609/2013 on Foods for Specific Groups

Regulation (EU) No 609/2013 of the European Parliament and the Council on foods intended for infants and young children, foods for special medical purposes, and total diet replacement for weight control, otherwise known as the Regulation on ‘Foods for Specific Groups’, applied from the 20 July 2016. 

The Regulation on Foods for Specific Groups replaces the 2009/39/EC European Framework Directive on Foods for Particular Nutritional Uses (also called the ‘PARNUTs’ Framework), which established general rules for dietetic foods aiming to ensure product safety, suitability and appropriate consumer information and provided the framework for specific directives for certain groups of such foods, if necessary. 

Regulation (EU) No 609/2013 will repeal not only the PARNUTs Framework, but also each of the specialist PARNUTs directives and associated pieces of legislation. The Commission has adopted delegated regulations for infant formula and follow-on formula and foods for special medical purposes, and is to adopt delegated regulations for processed cereal based food, baby food and total diet replacement for weight control.

Regulation (EU) No 609/2013 establishes a Union List of Substances that may be added to one or more of the categories of food it legislates for and lays down the rules applicable to the updating of that list.

As with all foods, specialist foods for specific groups must comply with relevant legislation covering hygiene, labelling – including nutritional labelling - additives, contaminants, weights and measures, nutrition and health claims and advertising.

Until the delegated regulations under the Regulation on Foods for Specific Groups apply, manufacturers may still adhere to the directives under the PARNUTs Framework. 

Specific specialist directives under the PARNUTs Framework include:

Infant and follow-on formula

The European Commission Delegated Regulation (EU) 2016/127, supplementing Regulation (EU) No 609/2013, which updates the specific compositional and information requirements for infant and follow-on formula entered into force on 22 February 2016, being fully applicable by February 2020 (or February 2021 for protein hydrolysate based formulae). The previous regulations under Directive 2006/141/EC, remain in force until repealed at this date. This regulation specifies the nutritional composition of IF and FOF, including labelling and claims provisions specific to this group. 

Foods for Special Medical Purposes

The European Commission Delegated Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013, which updates the specific compositional and information requirements for foods for special medical purposes, entered into force on the 22 February 2016. It shall apply from 22 February 2019, except in respect of foods for special medical purposes developed to satisfy the nutritional requirements of infants, to which it shall apply from 22 February 2020.

Complementary foods

Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children currently provides the legislative requirements for the composition and labelling of complementary weaning foods for infants and young children. The annexes of the Directive provide strict criteria for the levels of protein, carbohydrate, fat, vitamins and minerals to be found in specific categories of weaning foods, and where necessary gives maximum and minimum levels based on advice from the Scientific Committee on Food.

The Directive also encompasses rules on pesticide residues, requiring that baby food contains no detectable levels of pesticide residues, and prohibits certain pesticides in the production of processed cereal-based baby foods. 

The European Commission will be reviewing this legislation under the framework of the new FSG Regulation.

Gluten-free Foods

Commission Implementing Regulation (EU) No 828/2014 provides the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food. The regulation is legislated under the framework of Regulation (EU) No 1169/2011 on the provision of food information to consumers.  

The Implementing Regulation came into force on 20 July 2016, repealing Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten, adopted under the PARNUTs Framework Directive. 

Regulation (EU) No 828/2014 sets out the conditions under which foods may be labelled as ‘gluten-free’ or ‘very-low gluten’.

  • The statement ‘gluten-free’ may only be used where the food as sold to the final consumer contains no more than 20 mg/kg of gluten.
  • The statement ‘very-low gluten’ may only be used where the food, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, contains no more than 100 mg/kg of gluten in the food as sold to the final consumer.

These statements are not different from those previously laid down in Regulation (EC) No 41/2009. However they do now apply to non pre-packed foods, such as those served in restaurants. Regulation (EU) No 828/2014 also provides information on how manufacturers can inform consumers about the difference between foods specifically formulated to be gluten-free and those which are naturally free of gluten.