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Total Diet Replacement for Weight Control

Total Diet Replacement for Weight Control

Legislative requirements for total diet replacement for weight control products.

  • What are total diet replacement for weight control products?

    Total diet replacement for weight control (TDR) products are a food category defined in Regulation (EU) 609/2013 as ‘food specially formulated for use in energy restricted diets for weight reduction which, when used as instructed by the food business operator, replaces the whole daily diet’.

    These complex products are specially formulated for adults living with overweight or obesity who intend to achieve weight reduction. The essential composition must satisfy the daily nutritional requirements of adults living with overweight or obesity in good health, in the context of energy-restricted diets for weight reduction, as established by generally accepted scientific data.

  • EU Legislation

    Commission Delegated Regulation (EU) 2017/1798 for total diet replacement for weight control products came into force on 27 October 2022.

    As amended by:

  • National Legislation

    European Union (Food Intended for Infants and Young Children, Food for Special Medical Purposes, and Total Diet Replacement for Weight Control) Regulations 2019 (S.I. No. 425/2019)

  • Labelling Requirements

    Total diet replacement (TDR) for weight control products must comply with Regulation (EU) No 1169/2011 of the European Parliament and of the Council. Additions and exceptions to these general rules concerning the nutrition declaration are outlined in Article 5 of Regulation (EU) 2017/1798. The mandatory nutrition declaration for TDR for weight control products shall include:

    • the amount of each mineral substance and of each vitamin listed in Annex I to Regulation (EU)2017/1798 that are present in the product;
    • the amount of choline present, and if added, of dietary fibre;
    • the energy value and the amounts of nutrients expressed per total daily ration as well as, per portion and/or per consumption unit of the food ready for use after preparation in accordance with the manufacturer's instructions. Where appropriate, information may in addition refer to 100 g or 100 ml of the food as sold;
    • the indication of the amount of sodium together with the other minerals. Sodium may be repeated next to the indication of the salt content as follows: ‘Salt: X g (of which sodium: Y mg)’.

    The information included in the mandatory nutrition declaration for total diet replacement for weight control products shall not be repeated on the labelling.

    The energy value and amount of nutrients of total diet replacement for weight control products shall not be expressed as a percentage of reference intakes set out in Annex XIII to that Regulation. 

    The following voluntary statements may be used:

    • ‘very low calorie diet’ - provided that the energy content of the product is below 3 360 kJ/day (800 kcal/day). 
    • ‘low calorie diet’ - provided that the energy content of the products is between 3 360 kJ/day (800 kcal/day) and 5 040 kJ/day (1 200 kcal/day).

  • Compositional Requirements

    The essential composition must satisfy the daily nutritional requirements of overweight or obese adults in good health, in the context of energy-restricted diets for weight reduction, as established by generally accepted scientific data. 

    With these conditions in mind the compositional requirements TDR for weight control products are laid down in Annex I, while considering the amino acid requirement pattern specified in Annex II of Regulation (EU) 2017/1798. This applies to the food ready for use, marketing as such or after preparation in accordance with the manufacturer’s instructions.

    Annex I to Delegated Regulation (EU) 2017/1798 was amended with respect to alpha-linoleic and magnesium content of TDR for weight control products as follows:

    • The alpha-linolenic acid contained in total diet replacement for weight control products shall not be less than 0,8 g for the total daily ration.
    • Total diet replacement for weight control products shall not contain more than 250 mg of magnesium for the total daily ration.

  • Nutrition and Health Claims

    Nutrition and health claims are not permitted on total diet replacement for weight control products. An ‘added fibre’ nutrition claim may be used on the condition that the dietary fibre content of the product is not less than 10 g.

  • Notification Obligation

    Total diet replacement for weight control products placed on the Irish market must be notified to the FSAI using the online FSAI Food Notification System.

    The duty falls on the food business operator to send a model of the label used for the product, and of any other information the competent authority may reasonably request to establish compliance with Regulation (EU) 2017/1798, unless a Member State exempts the food business operator from that obligation under a national system that guarantees an efficient official monitoring of the product concerned. 

    If you intend to place a total diet replacement for weight control product on the market in Ireland, you should check with your supplier to verify if they have already notified the product. If they have already done so, you do not need to submit a duplicate notification, but you should request a copy of the notification number(s) from the supplier to keep as part of your records.

    If the total diet replacement for weight control products you sell have not been notified, you will need to complete the notification yourself.

  • Importing

    Information can be found here on food import requirements, including total diet replacement for weight control products.

  • Enforcement

    The Health Service Executive (HSE) enforces the applicable food legislation under service contract with the FSAI and undertakes routine and coordinated programmes on the sampling and analysis of relevant food products to check for compliance.

    If non-compliant TDR products are identified during official controls, appropriate enforcement action may be taken. This may include prosecution and product withdrawal/recall as appropriate.