IMPLEMENTING REGULATION SETS COMPOSITIONAL AND INFORMATION REQUIREMENTS FOR TOTAL DIET REPLACEMENT.

From 27 October 2022 total diet replacement products will need to comply with the requirements as set by implementing Regulation (EU) 2017/1798 of 2 June 2017 (see link below) on total diet replacement for weight control. The Implementing Regulation was published on 7 October 2017 establishing compositional criteria, labelling standards and the obligation to notify total diet replacement products in the member states of destination.

‘Total diet replacement’ concerns a particular category foods which are specially formulated to replace the whole daily diet, for use in energy restricted diets with the purpose of weight reduction when used as instructed. Total diet replacement products fall under the general framework of Regulation (EU) No 609/2013 of 12 June 2013 of foods for specific groups together with foods intended for infants and young children and foods for special medical purposes. The latter Regulation mandated the Commission to adopt specific rules for either category.  For that purpose Regulation 2017/1798 of 2 June 2017 was adopted.

The compositional criteria for total diet replacement products can be found in the Annexes of Regulation (EU) 2017/1798 of 2 June 2017. These comprise minimum requirements on the amounts of energy, protein, choline, linoleic acid and alpha-linolenic acid, carbohydrates and vitamins and minerals (Annex I) as well as specifications on the amino acid composition of proteins (Annex II). The addition of other substances is allowed insofar the suitability has been established by generally accepted scientific data.

Information requirements for total diet replacement adhere to the Food Information to Consumers Regulation (Regulation (EU) No 1169/2011), except for the introduction of certain mandatory statements and substantial deviations regarding the nutrition declaration. For instance, a statement indicating that the product is only intended for healthy overweight or obese adults who intend to achieve weight reduction should be included on the labelling. References to the rate or amount of weight reduction which may result from the use of total diet replacement are not allowed. Furthermore, the Regulation imposes that the nutrition declaration cannot be omitted for reasons of limited space on the packaging. The indication of vitamins, minerals, choline and added fibre in the nutrition declaration is mandatory. All amounts should be expressed on a per portion and/or per consumption unit as well as per total daily ration. Indication 100 g or 100 ml may be provided on a voluntary basis. Moreover, the Regulation allows for the indication of the amounts of components of carbohydrates and fats other than specified in Regulation 1169/2011, substances listed in the Annex to Regulation 609/2013 or other added substances. The use of reference intakes is excluded.

A general prohibition on the use of nutrition and health claims applies. Only, the indications ‘very low calorie diet’ or ‘low calorie diet’ and ‘added fibre’ may be provided under the applicable conditions.

Lastly, in line with Regulation 609/2013, the implementing Regulation requires total diet replacement products to be notified to the competent authority of each Member State where the product concerned is being marketed. For that purpose, a model of the label and other information  which may be requested by authorities should be forwarded. Member states may however provide for an alternative scheme to monitor compliance.

Full text of the implementing Regulation: Commission Delegated Regulation (EU) 2017/1798 of 2 June 2017 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for total diet replacement for weight control (EU O.J. of 7/10/2017)