EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10266/2022 
(POOL/E1/2022/10266/10266 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2017/1798 as regards the lipid and magnesium 
requirements for total diet replacement for weight control  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Article 11(2) of 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 2 006/141/EC, Directive 2009/39/EC of the European Parliament 
and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 
953/20091 empowers the European Commission to adopt delegated acts in order to 
update the delegated acts adopted pursuant to Article 11(1) of that Regulation, such 
as 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 require ments for total diet  
replacement for weight control2. 
This Delegated Regulation aims to amend Delegated Regulation (EU) 2017/1798 by 
abolishing the minimum requirement on linoleic acid, lowering the minimum content 
of alpha -linoleic acid as well as by increasing the maximum content of magnesium 
set out in the Regulation.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consulted the Euro pean Food Safety Authority (`Authority`) on the 
matter. The Authority` s Statement on additional scient ific evidence in relation to the 
essential composition of total diet replacement for weight control3 constitutes the 
scientific basis for the requirements in this delegated Regulation . 
Member States' experts were consulted in writing in the context of the Expert Group 
on food intended for infants and young children, food for special medical purposes 
and total diet replacement for weight control4 between 13 July 2021 and 10 
September 2021, between 25 November 2021 and 13 December 2021 as well as 
between 16 F ebruary 2022 and 28 February 2022.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis of this delegated Regulation is Article 11(2) of Regulation (EU) 
No 609/2013 . According to that provision the Commission is empowered to adopt 
delegated acts in order to update the delegated acts adopted pursuant to Article 11(1) 
of that Regulation, such as Delegated Regulation (EU) 2017/1798 subject to the 
general requirements se t out in Article s 6 and 9 of Regulation (EU) No  609/2013 , to 
the additional requirements of Article 10 thereof,  and taking into account relevant 
technical and scientific progress.  
The proposed changes to Delegated Regulation (EU) 2017/1798 relate to  the 
abolishment of the minimum requirement on linoleic acid , the reduction of the alpha -
                                                 
1 OJ L 181, 29.6 .2013, p. 35.  
2 OJ L 259, 7.10.2017, p. 2 . 
3 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 . 
4 Reference E02893 in the Register of Commission Expert Groups and other similar entities.   
EN 2  EN linoleic acid content required for total diet replacement for weight control as well as 
the increase of the maximum magnesium content permitted for those products.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Delegated Regulation (EU) 2017/1798 as regards the lipid and magnesium 
requirements for total diet replacement for weight control  
(Text wi th 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 you ng 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 953/20091, and in particular 
Article  11(2) thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU)  2017/17982 lays down, inter alia , specific 
compositional requirements for  total diet replacement for weight control that are based 
on the latest scientific advice3 of the European Food Safety Authority (‘the Authority’) 
on the matter .  
(2) Delega ted 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 opinion4 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 . 
                                                 
1 OJ L 181, 29.6.2013, p. 35.  
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 ). 
3 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and A llergies), 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 Diet ary Reference Values for choline, EFSA Journal 2016;14(8):4484.  
4 EFSA Journal 2016;14(8):4484.   
EN 4  EN (4) In its statement of 15 April 2021 on the additional scientific eviden ce in relation to the 
essential composition of total diet replacement for weight control5, 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 durin g 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 d iarrhoea , 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 tha t 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 Reg ulation (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 th erefore 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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN  
                                                 
5 EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), 2021. Statement on 
additional scientific evidence in relation to the essential compo sition of total diet replacement for 
weight control. EFSA Journal 2021;19(4):6494.