EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10128/2016 
(POOL/E1/2016/10128/10128 -EN.doc)  
[…](2017) XXX  draft  
  
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(Text with EEA relevance)    
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT   
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 control1 repeals Directive 
2009/39/EC of the European Parliament and of the Cou ncil of 6 May 2009 on 
foodstuffs intended for particular nutritional uses2 from 20 July 2016 . Article 11 of 
the Regulation empowers the European Commission to adopt , amongst others  
delegated act laying down specific compositional and information requiremen ts for  
total diet replacement for weight control .  
Recital 27 of the Regulation requires the Commission to take into account, when 
adopting such rules, Commission Directive 1996/8/EC of 26 February 1996 on foods 
intended for use in energy -restricted diets for weight reduction3. 
In accordance with Article 20(4) of the Regulation the existing Commission 
Directive 1996/8/EC will be  repealed from the date of application of the delegated 
act adopted by the Commission . 
This delegated Regulation updates the existi ng rules of Commission Directive 
96/8/EC regarding total diet replacement for weight control with an energy content 
between 3 360 kJ (800kcal) and 5 040kJ (1200kcal) and lays down specific rules on 
total diet replacement with an energy content fewer than 3  360kJ (800kcal) on the 
basis of consultations described in point 2.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
The Commission consulted the European Food Safety Authority (EFSA) on the 
matter . EFSA's Scientific Opinion on the essential composition of total diet 
replacement for weight control4 constitutes the scientific basis for the requirements in 
this delegated Regulation . 
Member States' experts were consulted 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 control5, which met on the subject on 20 April  20156, 
22 June 2015  and 19  May 20167. Additional written consultations of the Expert 
Group were carried out between 25 February 2016 and 11 M arch 2016; and between 
12 October 2016 and 27 October 2016.  
Other stakeholders were consulted in the context of the Advisory Group on the Food 
Chain and Animal and Plant Health,8 which held a Working Group on the subject on 
                                                 
1 OJ L 181, 29.6.2013, p. 35 . 
2 OJ L 124, 20.5.2009, p. 21 . 
3 OJ L 55, 6.3.1996, p. 22.  
4 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2015. Scientific Opin ion 
on the essential composition of total diet replacements for weight control. EFSA Journal 
2015;13(1):3957.  
5 Reference E02893 in the Register of Commission Expert Groups and other similar entities.  
6 http://ec.europa.eu/food/safety/docs/20150420_sum_rep ort_fsg_en.pdf . 
7 http://ec.europa.eu/food/safety/docs/ln_special_exp_group_20150622_sum_report_fsg_en.pdf . 
8 Reference E00860 in the Register of Commission Expert Groups and other similar entities.   
EN 3   EN 18 June  20159. The possibility t o provide written comments was granted to all 
interested parties and comments were taken into account where relevant. Bilateral 
meetings were also held with all interested parties, as appropriate.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The legal basis of t his Delegated Regulation is Article 11 of Regulation (EU) 
No 609/2013 . According to that provision the Commission is empowered to adopt 
specific compositional and labelling requirements applicable to total diet replacement 
for weight control products.  
With respect to the composition, the proposed changes compared to Directive 
96/8/EC  relate to the f act that Directive 96/8/EC includes in its scope only total diet 
replac ement for weight control  products  with a daily  energy content between 
3 360 kJ (800kcal) and 5 040 kJ (1 200 kcal)  and that the compositional requirements 
are based on science from 199010. However, recital 16 Regulation (EU) No 609/2013 
explains that there are also products placed on the market with lower than 3 360 kJ 
(800kcal) replacing the t otality of the daily diet. Given the nature of the foods in 
question it is appropriate to update the specific provisions of total diet replacement 
for weight control with an energy content between 3  360 kJ (800kcal) and 5 040 kJ 
(1 200 kcal) and to lay dow n certain specific provisions for products with lower than 
3 360 kJ (800kcal) replacing the totality of the daily diet .  
With respect to labelling, changes are proposed  to ensure consistency with horizontal 
rules of Regulation (EU) No 1169/2011 of the Euro pean Parliament and of the 
Council of 25 October 2011 on the provision of food information to consumers11, 
while taking into account the specificities of the products.  
Given that total diet replacement for weight control products can  have significantly 
reduced energy content  and can be used as a sole source of nutrition for several 
weeks without the advice of health care professionals by healthy obese and 
overweight adults with the intention of weight  reduction , it is proposed to limit the 
possibility to ma ke nutrition claims and to forbid health claims on this type of food.  
The notification procedure is introduced in order to facilitate efficient monitoring of 
these products.  
The application of the delegated Regulation is deferred to allow food business 
operators to adapt to the technical changes.  
                                                 
9 http://ec.europa.eu/dgs/health_food -safety/dgs_consultations/docs/dgs -consultations_working -
groups_20150618_summary_en.pdf . 
10 Report of the Scientific Committee for Foods on foods intended for weight control diets, 19 October 
1990, https://ec.europa.eu/foo d/sites/food/files/safety/docs/labelling_nutrition -special_groups_food -
weight_reduction -scf_reports_27_en.pdf  
11 OJ L 304, 22.11.2011, p. 18 .  
EN 4   EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
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  
(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 d iet 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 41/2 009 and (EC) No 953/200912, and in particular 
Article  11(1) (a), (c) and  (d) thereof,  
Whereas:  
(1) Commission Directive 96/8/EC13 lays down harmonised rules on foods intended for 
use in energy -restri cted diets for weight reduction  and includes within its scope 
products defined in Regulation (EU) No 609/2013 as total diet replacement for weight 
control products .  
(2) Regulation (EU) No  609/2013 repeals Directive 96/8/EC  and lays down general 
compositional and information requirements fo r different categories of food including 
products defined as total diet replacement for weight control. In order for the 
Commission to comply with its obligation to adopt specific compositional and 
information requirements for total diet replacement for we ight control  products , it is 
appropriate to build on  the provisions of Directive 96/8/EC  as those provisions have 
ensure d the free movement of foods presented as total diet replacement for weight 
control in a satisfactory manner while ensuring a high level  of protection of public 
health .  
(3) Total diet replacement for weight control is a complex product that is specially 
formulated for overweight or obese adults who intend to achieve  weight reduction . 
The essential composition of total diet replacement for wei ght control products 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.  
(4) In order to ensure the safety an d suitability of total diet replacement for weight control  
products , detailed requirements should be laid down on their composition , including  
                                                 
12 OJ L 181, 29.6.2013 , p. 35.  
13 Commission Directive  96/8/EC of 26 February 1996 on food intended for use in energy  restricted diets 
for weight reduction (OJ L 55, 6.3.1996, p.  22).  
EN 5   EN requirements  on energy value, macronutrient and micronutrient content. Th ose 
requirements should be based on the latest scientific advice of the European Food 
Safety Authority ('the Authority')14 on the matter.  
(5) In order to ensure innovation and product development, the voluntary addition to total 
diet replacement for weight control  products  of ingredients  not covered by specific 
requirements of this Regulation , with particular attention to dietary fibre, should be 
possible.  All ingredients used in the manufacture of  total diet replacement for weight 
control  products should be suitable for healthy overweigh t or obese adults  and their 
suitability should have been demonstrated, when necessary, by appropriate studies. It 
is the responsibility of food business operators to demonstrate such suitability and of 
national competent authorities to consider, on a case by case basis, whether this is the 
case.  
(6) Total diet replacement for weight control products have to comply with Regulation 
(EU) No 1169/2011 of the European Parliament and of the Council15. In order to take 
account of the specific nature of total diet repla cement for weight control  products , 
additions and exceptions to those general rules  should be laid down , where 
appropriate.  
(7) It is essential that the nutrition  declaration  of total diet replacement for weight control 
products is declared in order to guaran tee it is used appropriately by both healthy 
overweight or obese adults consuming that food and by health care professionals who 
can advise on its appropriateness in certain cases. In order therefore to provide more 
complete information, the nutrition decl aration  should include more particulars  than 
those required by Regulation (EU) No 1169/2011. In addition,  the obligation to 
declare the nutrition declaration should be mandatory for all total diet replacement for 
weight control products irrespecti ve of the  package or container size , therefore the 
exemption provided for in point 18 of Annex V to Regulation (EU) No 1169/2011 
should not apply .  
(8) In order to provide appropriate information and to facilitate product comparisons, the 
nutrition declaration for tota l diet replacement for weight control  products  should be 
expressed per portion  and/or per consumption unit as well as per total daily ration. In 
addition , such information should refer to the product  ready for use after  preparation in 
accordance with the m anufacturer's instructions.   
(9) Article 30(2) of Regulation (EU) No 1169/2011 lists a limited number of nutrients that 
may be included on a voluntary basis in the nutrition declaration for food. The Annex 
to Regulation (EU) No 609/2013 lists a series of subst ances that may be added to total 
diet replacement for weight control products , some of which are not covered by 
Article 30(2) of Regulation (EU) No 1169/2011. In order to ensure legal clarity, it 
should be laid down explicitly that the nutrition declaratio n for total diet replacement 
for weight control  products  may include such substances. In addition, in certain cases, 
                                                 
14 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 . 
15 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 
the provision of food information to consumers , amending Regulations (EC) No 1924/2006 and (EC) 
No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 
87/250/EEC, Council Dire ctive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC 
of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and 
Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18 ).  
EN 6   EN more detailed information on carbohydrate and fat present in the product could be 
useful for consumers and health care professionals. Food business operators should 
therefore be allowed to provide such information on a voluntary basis.  
(10) Healthy overweight or obese adults may have different nutritional needs than the 
general population . In addition, total diet replacement for weight control is a food that 
fully replaces the daily diet. For those reason s, the expression of nutrition information 
on the energy value and the amount of nutrients of total diet replacement for weight 
control  products  as a percentage of daily reference intake values set out for the general 
population in Regulation (EU) No 1169/2011 would mislead consumers and should  
therefore  not be allowed.  
(11) Statements relating to the "very low" or "low" calorie content of total diet replacement 
for weight control  products can provide  useful information to consumers . Therefore it 
is appropriate to lay down rules on such voluntary statements.  
(12) Nutrition and health claims are promotional tools that are used on a voluntary basis by 
food business operators in commercial communication, in li ne with the rules of 
Regulation (EC) No 1924/2006 of the European Parliament and of the Council16. 
Given the particular role of  total diet replacement for weight control  products  in the 
diet of  people consuming them , the use of nutrition and health claims s hould not be 
allowed for  such products . Taking however into account that information on  the 
presence of  dietary fibre  in total diet replacement for weight control products can be 
useful  for consumers , provision should be made to allow nutrition claim s to be made  
on the addition of dietary fibre under certain conditions . 
(13) Directive 96/8/EC  required dietary fibre to be added to total diet replacement for 
weight control products . Due to the lack of scientific evidence  in its regard the 
Authority could not esta blish a minimum content for dietary fibre in its latest opinion. 
For these reasons, it is appropriate to maintain the minimum amount for dietary fibre 
required under Directive 96/8/EC, if it is added to total diet replacement for weight 
contro l products . 
(14) Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the 
Council17 requires Member States to enforce food law  and to  monitor and verify that 
the requirements  are fulfilled by food and feed business operators at all stages of 
product ion, processing and distribution. In this context, in order to facilitate the 
efficient official monitoring of total diet replacement for weight control food, business 
operators placing such products on the market should provide the national competent 
authorities with a model  of the label used and all relevant information  considered 
necessary by the competent authorities for the purposes of verifying  compliance with 
this Regulation , unless Member States have a different efficient monitoring system.  
(15) In order  to enable food business operators to adapt to the new requirements  that may 
involve technical adaptation to the manufacturing process of the products concerned,  
this Regulation  should apply from a date that is five years after its entry into force , 
                                                 
16 Regulation (EC ) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 o n 
nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9).  
17 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 layin g 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety  (OJ L 31, 1.2. 2002, p. 1).   
EN 7   EN HAS AD OPTED THIS REGULATION:  
Article 1  
Subject matter   
This Regulation lays down  the following specific requirements with regard to total diet 
replacement for weight control products:  
(a) compositional requirements;  
(b) requirements for labelling,  presentation a nd advertising;  
(c) notification requirements for placing the product on the market.  
Article 2 
Placing on the market  
1. The product name under which food covered by Article 2(2)(h) of Regulation (EU) 
No 609/2013 is sold shall be 'total diet replacement for  weight control'.  
2. Total diet replacement for weight control  products may only be placed on the market  
where  they compl y with this Regulation . 
Article 3 
Compositional requirements  
1. Total diet replacement for weight control  products shall comply with the 
compositional requirements  set out  in Annex I , taking into account the specifications 
in Annex II .  
2. The compositional requirements set out in Annex I shall apply  to the food ready for 
use, marketed as such or after preparation in a ccordance with the manufacturer's 
instructions .  
3. Total diet replacement for weight control products may contain other ingredients 
than the substances listed in Annex I only if their suitability has been established by 
generally accepted scientific data.   
Article 4 
 Specific requirements concerning food information  
1. In addition to the mandatory particulars listed in Article 9(1) of Regulation (EU) 
No 1169/2011, the following shall be additional mandatory particulars for total diet 
replacement for weight control  products :  
(a) a statement that the product is  only intended for healthy overweight or obese 
adults who intend to achieve weight  reduction ; 
(b) a statement that the product should be not used by  pregnant or lactating 
women , adolescents or by individ uals suffering from a  medical condition  
without the advice of a health care professional;  
(c) a statement on the importance of maintaining an adequate daily fluid intake ; 
(d) a statement that the product provides adequate daily amounts of all essential 
nutrients when used in accordance with the instructions for use ;  
EN 8   EN (e) a statement that the product should not be used for more than eight weeks  or 
repeatedly  for short er periods  than this by healthy overweight or obese adults  
without the advice of a health care professional;  
(f) instructions for appropriate preparation, whe re necessary, and a statement as to 
the importance of following those instructions;  
(g) if a product, when used as instructed by the manufacturer, provides a daily 
intake of polyols in exc ess of 20 g per day, a statement that the food may have 
a laxative effect ; 
(h) if dietary fibre is not added  to the product , a statement that the advice of a 
health c are professional must be sought regarding the possibility of 
supplementing the product with dietary fibre . 
2. When appearing on the package or on the label attached thereto, the mandatory 
particulars listed in paragraph 1 shall be indicated  in such a way as to meet 
requirements laid down in Article 13(2) and (3) of Regulation (EU) No 1169/2011.  
3. The labelling, presentation and advertising of total diet replacement for weight 
control products shall not make any reference to the rate or amount of weight 
reduction  which may result from its use.  
Article 5 
Specific requirements concerning the nutritio n declaration  
1. In addition to the information referred to  in Arti cle 30(1) of Regulation (EU) 
No 1169/2011 , the mandatory nutrition declaration for total diet replacement for 
weight control  products  shall include the amount of each mineral  substance and of 
each vitamin listed  in Annex I to this Regulation that are present in the product.  
The mandatory nutrition declaration for total diet replacement for weight control  
products shall also include the amount of choline  present, and if added, of dietary 
fibre.  
2. In addition to the information referred to  in Article 30(2)(a) to (e) of Regulation (EU) 
No 1169/2011 , the content of the mandatory nutrition declaration for total diet 
replacement for weight control  products  may be supplemented , with: 
(a) the amounts of components of fat  and carbohydrates;  
(b) the amounts of any of the substances  listed in the Annex to Regulation (EU) 
No 609/2013, where such an indication is not covered by  paragraph 1  of this 
Article;  
(c) the amount of any of the substances added to the produ ct pursuant to 
Article  3(3). 
3. By way of derogation from Article 30(3) of Regulation (EU) No 1169/2011, the 
information included in the mandatory nutrition declaration for total diet replacement 
for weight control  products  shall not be repeated on the labelling.  
4. The nutrition declaration shall be mandatory for all total diet replacement for weight 
control  products , irrespective of the size of the largest surface of the packaging or 
container.   
EN 9   EN 5. All the nutrients include d in the nutrition declaration for total diet replacement for 
weight control  products  shall meet requirements laid down in Article 31 to 35 of 
Regulation (EU) No 1169/2011 . 
6. By way of derogation from Articles 31(3), 32(2) and 33(1) of Regulation (EU) 
No 1169/2011, the energy value and the amounts of nutrients of total diet 
replacement for weight control  products  shall be expressed per total daily ratio as 
well as , per portion and/or per consumption unit of the food ready for use after 
preparation in ac cordance with the manufacturer's instructions. Where appropriate, 
information may in addition refer to 100 g or 100ml of the food as sold.  
7. By way of derogation from Article 32(3) and (4) of Regulation (EU) No 1169/2011, 
the energy value and amount of nu trients 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.  
8. The particulars included in the nutrition declaration for total diet replacement for 
weig ht control  products  that are not listed in Annex XV to Regulation (EU) 
No 1169/2011 shall be presented after the most relevant entry of that Annex they 
belong  to or are components of . 
Particulars not listed in Annex XV to Regulation (EU) No 1169/2011 that do not 
belong to or are not components of any of the entries of that Annex shall be 
presented in the nutrition declaration  after the last entry of that Annex.  
The i ndication of the amount of sodium shall appear together with the other minerals 
and may be repeated next to the indication of the salt content as follows: “Salt : X g 
(of which sodium: Y mg)” . 
9. The statement "very low calorie diet" may be used for total diet replacement for 
weight control  products  provided that the energy content of the product is below  
3 360 kJ/day  (800kcal/day ) . 
10. The statement "low calorie diet" may be used for total diet replacement for weight 
control products provided that the energy content of the products is between 
3 360 kJ/day ( 800kcal/day ) and 5 040kJ/day ( 1200kcal/day ).  
Article 6  
Nutrition and Health Claims  
1. Nutrition and h ealth claims shall not be made on total diet replacement for weight 
control  products .  
2. By way of derogation from paragraph 1 the nutrition  claim "added fibre" may be 
used for total diet replacement for weight control products provided that the dietary 
fibre content of t he product is not less than 10g . 
Article  7 
Notification  
When total diet replacement for weight control  products are placed  on the market, the food 
business operator shall notify the competent authority of each Member State where the 
product concerned is being marketed of the information appearing on the label, by sending to 
it a model of the label used for the product, and of any other information the competent 
authority may reasonably request to establish compliance with this Regulation, unless a  
EN 10   EN Member State exempts the food business operator from that obligation under a national 
system that guarantees an efficient official m onitoring of the product concerned.  
Article 8 
References to Directive 96/8/EC  
References to Directive 96/8/EC in other acts shall be construed as references to this 
Regulation.   
Article 9 
Entry into force  
This Regulation shall enter into force on the twent ieth day following that of its publication  in 
the Official Journal of the European Union . 
It shall apply from [ 5 years after entry into force ].  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER