The New Regulation on Food for Specific Groups
The Regulation (EU) No 609/2013 of the European Parliament and the Council on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control ('Food for Specific Groups') was adopted on 12 June 2013 and applies from 20 July 2016. It 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.
What does the new Regulation do?
Strengthens provisions on foods for vulnerable population groups to ensure their protection.
Sets general compositional and labelling rules and require the Commission to adopt, through delegated acts, specific compositional and labelling rules for:
Infant and follow-on formula
Processed-cereal based food and other baby food
Food for special medical purposes
Total diet replacement for weight control
Simplifies the regulatory framework, by eliminating those rules that are unnecessary and contradictory and by replacing them with a new Framework which takes into account the developments on the market and in EU food law. In particular, the new Regulation abolishes the obsolete concept of "dietetic food" by repealing Directive 2009/39/EC, which previously laid down general rules for these products categories (specific rules on the different product categories adopted in the past under Directive 2009/39/EC remain applicable until the new specific rules have replaced them – see dedicated pages for more info)
Establishes a single Union list of substances that can be added to these foods including minerals and vitamins
Empowers the Commission to adopt interpretation decisions clarifying whether a given food falls within the scope of the Regulation and under what specific food category, in order to ensure uniform implementation of the rules.
Requires the Commission to transfer rules on gluten-free foods and very low gluten under Regulation (EU) No 1169/2011 on food information to consumers in order to ensure clarity and consistency.
Establishes that meal replacement products for weight control should be regulated solely under Regulation (EC) No 1924/2006 on nutrition and health claims in order to ensure legal certainty.
What is foreseen?
The new Regulation foresees that two reports should be prepared by the Commission in order to analyse the need to establish special rules for:
young-child formulae (the so called "growing-up milks")
food intended for sportspeople.
The report on food intended for sportspeople was adopted by the Commission on 15 June 2016. The Commission report is mainly based on the results of an external study commissioned by DG SANTE by the Food Chain Evaluation Consortium (FCEC) titled "Study on food intended for Sportspeople". Download the study: Study and Annexes.
Both reports conclude that there is no necessity for specific provisions for these products. From 20 July 2016, young-child formulae and food intended for sportspeople are exclusively covered by horizontal rules of EU food law.
- Press Release: New strengthened rules for infants, young children and food for special medical purposes
- Questions and Answers
- Impact Assessment
- Impact Assessment summaries