As of 27 October 2022, a new framework of rules will apply to total diet replacement products, both in terms of compositional and labelling requirements. In addition, total diet replacement products will have to be notified in each Member State where the product is being marketed. Those new rules are laid down in the Commission Delegated Regulation (EU) 2017/1798 on total diet replacement for weight control, published on 7 October 2017.

Total diet replacement for weight control’ products are foods specially formulated to replace the whole daily diet, for use in energy restricted diets intended for weight reduction, when used as instructed by the food business operator. They are defined in the Regulation (EU) 609/2013 and fall under its general framework together with foods intended for infants and young children and foods for special medical purposes. That same Regulation empowers the European Commission to specify the requirements for all the above mentioned foods through delegated acts. The Delegated Regulation 2017/1798 is the result of this delegation with regard to the total diet replacement products.

What are the main changes?

  • New compositional requirements: the compositional requirements for total diet replacement products are set out in the Annexes of the Delegated Regulation. They include the minimum amounts required of energy, protein, choline, lipids, carbohydrates, vitamins and minerals and specifications on amino acid composition of proteins. Other substances may be added provided that their suitability has been established on the basis of generally accepted scientific data.
  • The use of nutrition and health claims is prohibited except for the nutrition claims ‘very low calorie diet’, ‘low calorie diet’ and ‘added fibre’ provided that the required content amounts are respected;
  • Specific statements have to be mentioned on the label, such as, for instance, statements that the product:
    • is only intended for healthy overweight or obese adults who intend to achieve weight reduction;
    • should be not used by pregnant or lactating women, adolescents or by individuals suffering from a medical condition without the advice of a healthcare professional;
    • provides adequate daily amounts of all essential nutrients when used in accordance with the instructions for use;
    • should not be used for more than 8 weeks, or repeatedly for shorter periods than this, by healthy overweight or obese adults without the advice of a healthcare professional.
  • There is an absolute prohibition to refer to the rate or amount of weight reduction which may result from the use of the total diet replacement product (this is in accordance with article 12(b) of the Nutrition and Health Claims Regulation No. 1924/2006);
  • The indication of the nutrition declaration is mandatory in all circumstances, regardless of the space on the packaging or container. It is also mandatory to indicate vitamins, minerals, choline and added fibre in the nutrition declaration;
  • Contrary to what exists for ‘common’ foods, the nutrition declaration has to be expressed per total daily ration as well as per portion and/or per consumption unit of the food ready for use after preparation according to the instructions of the manufacturer. The reference to 100 g or 100 ml can be indicated on a voluntary basis. However, the indication of percentage of the reference intakes is not permitted;
  • It is prohibited to repeat the nutrition declaration.

Finally, in accordance with the provisions of the Regulation 609/2013, the Delegated Regulation imposes an obligation on food business operators to notify the information included on the label of the total diet replacement products to the competent authority of each Member State where the products are being marketed. To this end, food business operators have to provide the competent authority with a model of the label used for the products and any other information which may be requested in order to comply with the Delegated Regulation. Member States can, however, waive this obligation if they offer an alternative and efficient system to monitor the compliance.