Regulation 609/2013 on Foods Intended for Infants and Young Children, Food for Special Medical Purposes and Total Diet Replacement for Weight Control (the “Regulation”) entered into force on 20 July 2016.

The Regulation seeks to protect specific vulnerable groups by strengthening the provisions and regulating the content and marketing of certain ‘special’ food products. The Regulation abolishes the concept of ‘dietetic foods’ and repeals the previous Foods for Particular Nutritional Uses (“PARNUTs”) framework. 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

The Regulation sets out general compositional and information requirements and specific compositional and information requirements for the ‘special’ foods. A list which sets out the substances that can be added to ‘special’ foods is also included.

The general requirements require that the food must be appropriate for the nutritional requirements for the persons for whom it is intended and the information provided on labelling, presentation and advertising must be appropriate and must not mislead or claim that the particular food can prevent, treat or cure a disease.

Specific Requirements and Delegated Acts

With respect to the specific requirements relating to the ‘special’ foods, the Commission is empowered to adopt delegated acts under the Regulation in the following areas:

  • Specific compositional requirements
  • Pesticide use and residues
  • Specific requirements on the labelling, presentation and advertising
  • Notification requirements for the placing of the food on the market (for the purposes of official monitoring)
  • Requirements concerning promotional and commercial practices relating to infant formula
  • Requirements concerning information to be provided in relation to infant and young child feeing in order to ensure adequate and appropriate feeding practices
  • Specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants and requirements on the use of pesticides in these products, pesticide residues, labelling, presentation, advertising and promotional and commercial practices

To date the following delegated acts have been adopted:

  • Infant formula and follow-on formula - Commission Delegated Regulation 2016/127 will enter into force on 22 February 2020 and repeal Directive 2006/141/EC from that date (except for formula from protein hydrolysates where the delegated regulation will apply from 21 February 2021); and
  • Food for special medical purposes - Commission Delegated Regulation 2016/128 will enter into force on 22 February 2019 and repeal Directive 1999/2/EC from that date (except in relation to food for special medical purposes developed to satisfy the nutritional requirements of infants which will remain governed by Directive 1999/2/EC until 21 February 2020).

Foods Excluded from the Regulation 

Two food products which had been classified as dietetic foods under PARNUTs are not within the scope of the new Regulation:

  • Food intended for sports people; and
  • Milk based drinks and similar products for young children, for example Growing Up Milk (this is a separate category to formula)

Therefore, from 20 July 2016, the general food law rules apply to these food products. In addition, there have been changes to the regulation of the following food types:

  • Gluten Free Food: The Regulation repealed Regulation (EC) No 41/2009 from 20 July 2016. Rules with respect to gluten free foods are now governed by Regulation (EC) No. 1169/2011 and Regulation (EC) No 828/2014.
  • Food for Diabetics: Report of the European Commission has concluded that such foods should be governed by general food legislation.
  • Meal Replacement for Weight Control: The Regulation only covers compositional and labelling rules for total diet replacement products for weight control and not meal replacement for weight control. Statements on meal replacement products will be regulated solely under Regulation (EC) No 1924/2006 on Nutrition and Health Claims.