# L_2022288EN.01001801.xml

| 9.11.2022 | EN | Official Journal of the European Union | L 288/18 |
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9.11.2022

EN

Official Journal of the European Union

L 288/18

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COMMISSION DELEGATED REGULATION (EU) 2022/2182

of 30 August 2022

amending Delegated Regulation (EU) 2017/1798 as regards the lipid and magnesium requirements for total diet replacement for weight control

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (1), and in particular Article 11(2) thereof,

Whereas:

| (1) | Commission Delegated Regulation (EU) 2017/1798 (2) lays down, inter alia, specific compositional requirements for total diet replacement for weight control that are based on the latest scientific advice (3) of the European Food Safety Authority (‘the Authority’) on the matter. |
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(1)

Commission Delegated Regulation (EU) 2017/1798 (2) lays down, inter alia, specific compositional requirements for total diet replacement for weight control that are based on the latest scientific advice (3) of the European Food Safety Authority (‘the Authority’) on the matter.

| (2) | Delegated Regulation (EU) 2017/1798 provides that total diet replacement for weight control is to contain at least 11g linoleic acid and 1,4 g alpha-linolenic acid for the total daily ration and that it is not to contain more than 250 mg of magnesium for the total daily ration, as set out in points 4.1, 4.2 and 6 of Annex I to that Regulation. |
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(2)

Delegated Regulation (EU) 2017/1798 provides that total diet replacement for weight control is to contain at least 11g linoleic acid and 1,4 g alpha-linolenic acid for the total daily ration and that it is not to contain more than 250 mg of magnesium for the total daily ration, as set out in points 4.1, 4.2 and 6 of Annex I to that Regulation.

| (3) | On 7 November 2019, the Commission received a request, accompanied by a list of new scientific evidence, from Total Diet & Meal Replacements Europe for the revision of the compositional requirements of linoleic acid, alpha-linolenic acid and magnesium in Delegated Regulation (EU) 2017/1798. On 10 March 2020, the Commission requested the Authority to assess the submitted scientific evidence together with any other relevant new scientific evidence available and, if necessary, to update the conclusions of its latest scientific opinion (4) as regards the minimum levels of linoleic acid and alpha-linolenic acid as well as the maximum level of magnesium in total diet replacement for weight control. |
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(3)

On 7 November 2019, the Commission received a request, accompanied by a list of new scientific evidence, from Total Diet & Meal Replacements Europe for the revision of the compositional requirements of linoleic acid, alpha-linolenic acid and magnesium in Delegated Regulation (EU) 2017/1798. On 10 March 2020, the Commission requested the Authority to assess the submitted scientific evidence together with any other relevant new scientific evidence available and, if necessary, to update the conclusions of its latest scientific opinion (4) as regards the minimum levels of linoleic acid and alpha-linolenic acid as well as the maximum level of magnesium in total diet replacement for weight control.

| (4) | In its statement of 15 April 2021 on the additional scientific evidence in relation to the essential composition of total diet replacement for weight control (5), the Authority concluded that there is no need to add linoleic acid to total diet replacement for weight control, as the amount released from the adipose tissue during weight loss when consuming total diet replacement for weight control is sufficient to cover the adequate intake for linoleic acid. The Authority further concluded that, while around 40 % of the adequate intake of alpha-linolenic acid could be provided by the release of alpha-linolenic acid from the adipose tissue during weight loss in overweight or obese individuals consuming total diet replacement for weight control, a minimum of 0,8 g/day needs to be supplied by total diet replacement for weight control in order to meet the adequate intake for alpha-linolenic acid. The Authority also concluded that an increase of the total maximum magnesium content in total diet replacement for weight control to 350 mg/day is not of concern. Even if magnesium may induce diarrhoea, the likelihood that magnesium-induced diarrhoea would occur as a result of such intake at a severity that may be considered of concern for overweight or obese individuals consuming total diet replacement for weight control is low, considering that those individuals more often suffer from constipation than diarrhoea. |
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(4)

In its statement of 15 April 2021 on the additional scientific evidence in relation to the essential composition of total diet replacement for weight control (5), the Authority concluded that there is no need to add linoleic acid to total diet replacement for weight control, as the amount released from the adipose tissue during weight loss when consuming total diet replacement for weight control is sufficient to cover the adequate intake for linoleic acid. The Authority further concluded that, while around 40 % of the adequate intake of alpha-linolenic acid could be provided by the release of alpha-linolenic acid from the adipose tissue during weight loss in overweight or obese individuals consuming total diet replacement for weight control, a minimum of 0,8 g/day needs to be supplied by total diet replacement for weight control in order to meet the adequate intake for alpha-linolenic acid. The Authority also concluded that an increase of the total maximum magnesium content in total diet replacement for weight control to 350 mg/day is not of concern. Even if magnesium may induce diarrhoea, the likelihood that magnesium-induced diarrhoea would occur as a result of such intake at a severity that may be considered of concern for overweight or obese individuals consuming total diet replacement for weight control is low, considering that those individuals more often suffer from constipation than diarrhoea.

| (5) | On the basis of the conclusions of the Authority, and in order to take into account scientific progress, it is appropriate to abolish the requirement on linoleic acid in Delegated Regulation (EU) 2017/1798, to lower the minimum alpha-linolenic acid content required under that Delegated Regulation and to increase the maximum magnesium content permitted for those products. |
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(5)

On the basis of the conclusions of the Authority, and in order to take into account scientific progress, it is appropriate to abolish the requirement on linoleic acid in Delegated Regulation (EU) 2017/1798, to lower the minimum alpha-linolenic acid content required under that Delegated Regulation and to increase the maximum magnesium content permitted for those products.

| (6) | Annex I to Delegated Regulation (EU) 2017/1798 should therefore be amended accordingly, |
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(6)

Annex I to Delegated Regulation (EU) 2017/1798 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Delegated Regulation (EU) 2017/1798 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 August 2022.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 181, 29.6.2013, p. 35.

1

(2)  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 (OJ L 259, 7.10.2017, p. 2).

2

(3)  EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opinion on the essential composition of total diet replacement for weight control, EFSA Journal 2015;13(1):3957, and EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2016. Scientific Opinion on the Dietary Reference Values for choline, EFSA Journal 2016;14(8):4484.

3

(4)  EFSA Journal 2016;14(8):4484.

4

(5)  EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), 2021. Statement on additional scientific evidence in relation to the essential composition of total diet replacement for weight control. EFSA Journal 2021;19(4):6494.

5

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ANNEX

Annex I to Delegated Regulation (EU) 2017/1798 is amended as follows:

| (1) | point 4.1 is deleted; |
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(1)

point 4.1 is deleted;

| (2) | point 4.2 is replaced by the following:

  ‘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.’; |
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(2)

point 4.2 is replaced by the following:

‘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.’;

| (3) | in point 6, the second paragraph is replaced by the following:

  ‘Total diet replacement for weight control products shall not contain more than 350 mg of magnesium for the total daily ration.’. |
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(3)

in point 6, the second paragraph is replaced by the following:

‘Total diet replacement for weight control products shall not contain more than 350 mg of magnesium for the total daily ration.’.

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