Regulation (EU) N°609/2013 came into force on 20 July 2016 and national dispositions were supposed to be suppressed at this date. The new regulation aims 1) to reduce the number of categories of food for particular use which are thus subject to special provisions and 2) to ensure similar rules application in the member states.
The regulation defines the following categories of products:
• Infant and follow-on formula
• Processed-cereal based food and other baby food
• Food for special medical purposes, and
• Total diet replacement for weight control.
Other population and categories of products will be defined by the European Commission based on European Food Safety Agency (EFSA) recommendations. In addition, a specific delegate act with specific provision on composition, labeling and marketing procedure will be provided for each category of product. Generally speaking, composition of Food for Specific Groups (FSG) shall be suitable for the persons for whom it is intended to in accordance with generally accepted scientific data (article 9).
A specific focus will be made on food products that were removed from the dietetic regulation on 20 July 2016. Firstly, labelling and compositional rules indicating the absence or reduced presence of gluten in food is now determined through the Regulation (EC) 1169/2011 by the Commission Implementing Regulation (EU) No 828/2014. Secondly, communication on “Meal replacement for weight control intended to replace part of the daily diet’" is now regulated by general food law, and some health claims were authorized in the Commission Regulations (EU) No 432/2012 and N° 2016/1413 (e.g., Substituting one of the main daily meals of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss) for specific product composition. Thirdly, young children formula and food for sportspeople used to be regulated as dietetic foods in some countries (stakeholder stating that children between 1 to 3 years old or sportsmen have specific nutritional requirements).
Two reports were published by the European Commission on 31 March 2016 (for young children formula) and on 15 June 2016 (for food intended for sportspeople) which confirmed EFSA opinion that no special provisions regarding composition and labelling are required for those products. These products will indeed be regulated through horizontal legislation (addition of vitamins and minerals, nutrition and health claims, etc.). All other products defined as FSG in the national regulation (e.g., suitable for diabetics) will also be regulated through horizontal legislation.
In conclusion, Regulation (EU) N°609/2013 will increase consumer protection because 1) the possibility to bypass the regulation will be reduced with the suppression of national regulation on a lot of “non-categorized" products and 2) FSG rules will be harmonized with other current horizontal legislation (Nutrition and Health claims and Food Information to Consumer regulations).
Finally, the implementation in practice of the regulation on “defined" FSG (e.g., food for medical purposes, infant and follow up formula, food for total diet replacement for weight control) will rely on the delegated acts which publications were delayed.
Anne-Laure Tardy, Ph.D., is a scientific and regulatory affairs consultant at RNI Conseil. She earned a doctoral degree in human nutrition (University of Auvergne) and an MBA specialized in marketing for food products (Clermont-Ferrand Business School). Tardy has worked as researcher and lecturer at INRA and R&D engineer at Biophytis. She has experience raising preclinical and clinical studies, and published scientific contributions in health ingredients and nutrition. A member of the Vitafoods Europe scientific advisory board, Tardy has deep knowledge in the analysis of scientific data, new active ingredients, food supplements, dietetic products and medical food. She has also regulatory expertise in European and South America food laws.