REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant to Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control
Date: 2024-07-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, baby food, consumer information, delegated legislation, dietary product, food safety, labelling, marketing standard, powers of the institutions (EU), transfer of competence

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 30.7.2024  COM(2024) 346 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the delegation conferred on the Commission pursuant to Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the exercise of the delegation conferred on the Commission pursuant to Regulation 
(EU) No 609/2013 on food intended for infants and young children, food for special 
medical purposes and total diet replacement for weight control 

1.  Introduction  

This  report  meets  the  obligation  set  out  for  the  Commission  by  Article  18(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  (hereinafter  'Food  for  Specific  Groups  Regulation’)1.  The 
Food for Specific Groups Regulation establishes compositional and information requirements 
for (a) infant formula and follow-on formula, (b) processed cereal-based food and baby food, 
(c) food  for special medical  purposes and  (d)  total  diet replacement for  weight control. The 
Regulation  also  establishes  a  Union  list  of  substances  that  may  be  added  to  one  or  more  of 
these categories of food and lays down rules applicable to the updating of that list.  

Article 18(2) of the Food for Specific Groups Regulation requires the Commission to present 
to  the  European  Parliament  and  to  the  Council  a  report  on  the  exercise  of  the  delegation 
conferred  on  the  Commission  by  that  Regulation.  Pursuant  to  Article  18(2),  the  power  to 
adopt delegated acts was conferred on the Commission for an initial period of 5 years running 
from 19 July 2013. The Commission had to present a report on the exercise of the delegation 
of power conferred by the Food for Specific Groups Regulation not later than 9 months before 
the end of the 5-year period. The delegation of power is to be extended tacitly for periods of 5 
years, unless the European Parliament or the Council opposes such extension not later than 3 
months before the end of each period.  

The Commission adopted a first report on the exercise of the delegation of powers under the 
Food for Specific Groups Regulation on 22 August 20172.  

2.  Legal Basis  

Article 18(2) of the Food for Specific Groups Regulation lays down the conditions concerning 
the power to adopt delegated acts conferred on the Commission  by Article 11, Article 15(6) 
and Article 16(1) of that Regulation.  

Article 11(2) of the Food for Specific Groups Regulation empowers the Commission to adopt 
delegated acts in order to lay down specific compositional and informational requirements for 
the different categories of Food for Specific Groups. Those requirements are currently set out 
in the following Regulations:  

1 OJ L 181, 29.6.2013, p. 35. 
2  Report  from  the  Commission  to  the  European  Parliament  and  the  Council  on  the  exercise  of  the  delegation 
conferred on the Commission pursuant to Regulation (EU) No 609/2013 on food intended for infants and young 
children,  food  for  special  medical  purposes  and  total  diet  replacement  for  weight  control.  COM(2017)  0438 
final.  

1 

 
 
 
 
-  Commission  Delegated  Regulation  (EU)  2016/127  supplementing  the  Food  for 
Specific  Groups  Regulation  as  regards  the  specific  compositional  and  information 
requirements for infant formula and follow-on formula and as regards requirements on 
information relating to infant and young child feeding3,  

-  Commission  Delegated  Regulation  (EU)  2016/128  supplementing  the  Food  for 
Specific  Groups  Regulation  as  regards  the  specific  compositional  and  information 
requirements for food for special medical purposes4 and 

-  Commission  Delegated  Regulation  (EU)  2017/1798  supplementing  the  Food  for 
Specific  Groups  Regulation  as  regards  the  specific  compositional  and  information 
requirements for total diet replacement for weight control5. 

Article 15(6) of the Food for Specific Groups Regulation empowers the Commission to add or 
remove a category of substances to the Annex to the Regulation, which lays down the Union 
list of substances that may be added to the specific categories of foods, in order to take into 
account technical progress, scientific developments or the protection of consumer's health. 

Article 16(1) of the Food for Specific Groups Regulation empowers the Commission to adopt 
delegated acts in accordance with Article 18 of that Regulation, in order to amend the Annex 
of  the  Regulation  which  lays  down  the  Union  list  of  substances  that  may  be  added  to  the 
specific categories of foods. 

3.  Exercise of the delegation  

3.1. During the period starting on 22 August 2017 to date, the Commission has adopted the 
following  nine  delegated  acts  under  Article  11(2)  of  the  Food  for  Specific  Groups 
Regulation: 

a)  Commission Delegated Regulation (EU) 2019/828 amending Delegated Regulation (EU) 
2016/127  with  regard  to  vitamin  D  requirements  for  infant  formula  and  erucic  acid 
requirements for infant formula and follow-on formula6 

This  legal  act  was  adopted  on  14  March  2019  with  the  objective  to  ensure  the  highest 
level of protection of infants by lowering the maximum Vitamin D content permitted in 

3 Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 
609/2013 of the European Parliament and of the Council as regards the specific compositional and information 
requirements  for  infant formula  and  follow-on  formula  and  as  regards requirements  on  information relating  to 
infant and young child feeding, OJ L 25, 2.2.2016, p. 1. 
4 Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 
609/2013 of the European Parliament and of the Council as regards the specific compositional and information 
requirements for food for special medical purposes, OJ L 25, 2.2.2016, p. 30. 
5  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. 
6  Commission  Delegated  Regulation  (EU)  2019/828  of  14  March  2019  amending  Delegated  Regulation  (EU) 
2016/127  with  regard  to  vitamin  D  requirements  for  infant  formula  and  erucic  acid  requirements  for  infant 
formula and follow-on formula, OJ L 137, 23.5.2019, p. 12. 

2 

 
 
 
 
 
 
 
 
infant  formula  and  the  maximum  level  of  erucic  acid  for  infant  formula  and  follow-on 
formula,  based  on  the  scientific  opinions7,8  of  the  European  Food  Safety  Authority 
(EFSA). 

b)  Commission Delegated Regulation (EU) 2018/561 amending Delegated Regulation (EU) 

2016/127 with regard to protein requirements for follow-on formula9 

This  Delegated  Regulation  was  adopted  on  12  April  2018,  with  the  objective  to  allow 
food  business  operators  to  adjust  the  composition  of  follow-on  formula  by  introducing 
more flexibility, while ensuring a high level of protection of infants` health. It introduced 
technical  adjustments  to  already  existing  protein  requirements  for  follow-on  formula 
based on the scientific opinion10 of EFSA.  

c)  Commission Delegated Regulation (EU) 2021/572 amending Delegated Regulation (EU) 

2016/127 as regards the date of application of certain of its provisions11 

Regulation  (EU)  2016/127  establishes  that  formulae  manufactured  from  protein 
hydrolysates  can  only  be  placed  on  the  market  following  a  case-by-case  evaluation  of 
their  safety  and  suitability  by  EFSA.  Such  assessment  was  not  required  under  the 
previous  Commission  Directive  2006/141/EC  on  infant  and  follow-on  formula12. 
Commission Delegated Regulation (EU) 2021/572 was adopted on 20 January 2021 with 
the objective to avoid potential market disruptions, by deferring the entry into application 
of  the  new  requirement  of  a  case-by-case  assessment  of  hydrolysed  infant  formula  and 
follow-on  formula  laid  down  in  Delegated  Regulation  (EU)  2016/127.  In  fact,  the 
COVID-19 pandemic and the associated public health crisis caused unexpected delays in 
the scientific assessments  of the formulae by EFSA.  The one-year postponement of the 
entry  into  application  of  the  new  requirements  prevented  the  products,  which  were 
legitimately on the market in accordance with Commission Directive 2006/141/EC,  and 
for which no adverse health effects had been reported, from becoming unnecessarily non-
conform to the new requirements.  

7 Scientific opinion on erucic acid in feed and food, Erucic acid in feed and food | EFSA (europa.eu) 
8  Scientific  opinion  on  the  Update  of  the  tolerable  upper  intake  level  for  vitamin  D  for  infants,  Update  of  the 
tolerable upper intake level for vitamin D for infants - - 2018 - EFSA Journal - Wiley Online Library 
9 Commission Delegated Regulation (EU) 2018/561 amending Delegated Regulation (EU) 2016/127 with regard 
to protein requirements for follow-on formula OJ L 94, 12.4.2018, p. 1. 
10 Scientific Opinion on the safety and suitability for use by infants of follow‐on formulae with a protein content 
of at least 1.6 g/100 kcal, Scientific Opinion on the safety and suitability for use by infants of follow‐on formulae 
with a protein content of at least 1.6 g/100 kcal | EFSA (europa.eu) 
11 Commission Delegated Regulation (EU) 2021/572 of 20 January 2021 amending Delegated Regulation (EU) 
2016/127 as regards the date of application of certain of its provisions OJ L 120, 8.4.2021, p. 4. 
12  Commission  Directive  2006/141/EC  of  22  December  2006  on  infant  formulae  and  follow-on  formulae  and 
amending Directive 1999/21/EC, OJ L 401, 30.12.2006, p. 1. 

3 

 
 
 
 
 
 
 
d)  Commission  Delegated  Regulations  (EU)  2022/519,  (EU)  2023/589  and  (EU)  …/… 
amending  Delegated  Regulation  (EU)  2016/127  as  regards  the  protein  requirements  for 
infant and follow-on formula manufactured from protein hydrolysates13,14,15 

Delegated  Regulation  (EU)  2016/127  recalls  that  EFSA  considers  that  the  safety  and 
suitability  of  each  specific  formulae  manufactured  from  protein  hydrolysates  has  to  be 
established by clinical evaluation and allows the placing on the market of those formulae 
positively evaluated by EFSA. Three delegated acts were adopted by the Commission on 
14 January 2022, 10 January 2023, and on 2 February 2024 with the objective to allow 
the  placing  on  the  market  of  infant  and  follow-on  formulae  manufactured  from  the 
protein hydrolysates that were evaluated nutritionally safe and suitable by EFSA16,17,18 for 
use by infants between 2020 and 2023.  

e)  Commission  Delegated  Regulation  (EU)  2022/2182  amending  Delegated  Regulation 
(EU)  2017/1798  as  regards  the  lipid  and  magnesium  requirements  for  total  diet 
replacement for weight control19 

This  legal  act  was  adopted  on  30  August  2022  with  the  objective  to  update  certain 
compositional requirements for total diet replacement for weight control products, on the 
basis of the scientific opinion of EFSA20 and taking into account relevant technical and 
scientific progress, including data provided by interested parties.  

f)  Commission  Delegated  Regulation  amending  Delegated  Regulation  (EU)  2016/128  as 
regards the requirements on pesticides in food for special medical purposes developed to 

13 Commission Delegated Regulation (EU) 2022/519 of 14 January 2022 amending Delegated Regulation (EU) 
2016/127  as  regards  the  protein  requirements  for  infant  and  follow-on  formula  manufactured  from  protein 
hydrolysates, OJ L 104, 1.4.2022, p. 58. 
14 Commission Delegated Regulation (EU) 2023/589 of 10 January 2023 amending Delegated Regulation (EU) 
2016/127  as  regards  the  protein  requirements  for  infant  and  follow-on  formula  manufactured  from  protein 
hydrolysates, OJ L 79, 17.3.2023, p. 40. 
15 Commission Delegated Regulation (EU) …/... amending Delegated Regulation (EU) 2016/127 as regards the 
protein-related requirements for infant and follow-on formula manufactured from protein hydrolysates, 
16 Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and 
used in an infant and follow‐on formula manufactured from hydrolysed protein by Danone Trading ELN B.V., 
https://www.efsa.europa.eu/en/efsajournal/pub/6304  
17 Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and 
used  in  an  infant  and  follow-on  formula  manufactured  from  hydrolysed  protein  by  HIPP-Werk  Georg  Hipp 
OHG, https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2022.7141  
18 Nutritional safety and suitability of a specific protein hydrolysate derived from a whey protein concentrate and 
used  in  an  infant  formula  and  follow-on formula  manufactured  from  hydrolysed  protein  by  FrieslandCampina 
Nederland B.V., https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8063  
19 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, OJ L 
288, 9.11.2022, p. 18. 
20 Statement on additional scientific evidence in relation to the essential composition of total diet replacement for 
weight control, https://www.efsa.europa.eu/en/efsajournal/pub/6494  

4 

 
 
 
 
 
 
satisfy  the  nutritional  requirements  of  infants  and  young  children21  and  Commission 
Delegated Regulation (EU) 2016/127 as regards the requirements on pesticides in infant 
formula and follow-on formula22 

These  two  delegated  acts  were  adopted  by  the  Commission  on  16  April  2021  with  the 
objective  to  align  the  definition  of  “pesticide  residues”  laid  down  in  Delegated 
Regulation  (EU)  2016/128  and  Delegated  Regulation  (EU)  2016/127  with  the  more 
precise definition provided for in  Regulation  (EC) No 396/200523 on maximum residue 
levels of pesticides.  

3.2. So far, the Commission has not yet invoked the legal basis of Article 15(6) of the Food 
for  Specific  Groups  Regulation,  as  the  conditions  to  add  or  remove  a  category  of 
substances to the Annex to the Regulation have not been fulfilled yet. 

3.3  During  the period starting on 22 August 2017 to date, the Commission  has  adopted  the 
three  delegated  acts  below  under  Article  16(1)  of  the  Food  for  Specific  Groups 
Regulation: 

a)  Commission  Delegated  Regulation  (EU)  2021/571  amending  the  Annex  to  the  Food  for 
Specific Groups Regulation as regards the list of substances that may be added to infant 
and follow-on formula, baby food and processed cereal-based food24 

This  delegated  act  was  adopted  by  the  Commission  on  20  January  2021  with  the 
objective  to  update  the  Union  list  of  substances  that  may  be  added  to  the  specific 
categories  of  food  to  authorise  the  addition  of  calcium  L-methylfolate  as  a  source  of 
folate to  infant  formula,  follow-on formula, processed cereal-based food  and baby food 
on the basis of the scientific opinion of EFSA25. 

b)  Commission  Delegated  Regulation  (EU)  2023/439  amending  the  Annex  to  the  Food  for 
Specific Groups Regulation to allow the use of nicotinamide riboside chloride as a source 

21  Commission  Delegated  Regulation  (EU)  2021/1040  of  16  April 2021  amending  Delegated  Regulation  (EU) 
2016/128 as regards the requirements on pesticides in food for special medical purposes developed to satisfy the 
nutritional requirements of infants and young children, OJ L 225, 25.6.2021, p. 1. 
22  Commission  Delegated  Regulation  (EU)  2021/1041  of  16  April 2021  amending  Delegated  Regulation  (EU) 
2016/127  as  regards  the  requirements  on  pesticides  in  infant  formula  and  follow-on  formula,  OJ  L  225, 
25.6.2021, p. 4. 
23  Regulation  (EC)  No  396/2005  of  the  European  Parliament  and  of  the  Council  of  23  February  2005  on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC, OJ L 70, 16.3.2005, p. 1.  
24  Commission  Delegated  Regulation  (EU)  2021/571  of  20  January  2021  amending  the  Annex  to  Regulation 
(EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be 
added to infant and follow-on formula, baby food and processed cereal-based food, OJ L 120, 8.4.2021, p. 1. 
25 Calcium l-methylfolate as a source of folate  added for nutritional purposes to infant and follow-on formula, 
baby 
food, 
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.5947  

cereal-based 

processed 

food 

and 

5 

 
 
 
 
 
of  niacin  in  food  for  special  medical  purposes  and  total  diet  replacement  for  weight 
control26 

This legal act was adopted by the Commission on 16 December 2022 with the objective to 
update the Union list of substances that may be added to the specific categories of food to 
authorise the addition of nicotinamide riboside chloride as a source of niacin to food for 
special  medical  purposes  and  total  diet  replacement  for  weight  control  based  on  the 
scientific opinion of EFSA27. 

c)  Commission Delegated Regulation amending the Annex to the Food for Specific Groups 
Regulation  to  allow  the  use  of  iron  milk  caseinate  as  a  source  of  iron  in  total  diet 
replacement for weight control and in food for special medical purposes, excluding food 
for infants and young children28  

This delegated act was adopted on 29 January 2024 with the objective to update the Union 
list  of  substances  that  may  be  added  to  the  specific  categories  of  food  to  authorise  the 
addition  of  iron  milk  caseinate  as  a  source  of  iron  to  total  diet  replacement  for  weight 
control  and  food  for  special  medical  purposes,  excluding  food  for  infants  and  young 
children, based on the scientific opinion of EFSA29. 

4.  Conclusion  

Since  22  August  2017,  the  Commission  has  regularly  exercised  the  delegated  powers 
conferred to it under the Food for Specific Groups Regulation. The Commission has adopted 
delegated acts to update specific compositional requirements on infant and follow-on formula 
as well as on total diet replacement for weight control, based on EFSA`s opinions and taking 
into account relevant technical and scientific progress. Furthermore, the Commission updated 
the Union list of substances that may be added to the specific categories of food, on the basis 
of  EFSA`s  advice  taking  into  account  technical  progress,  scientific  developments  and 
protection  of  consumers'  health.  The  Commission  invites  the  European  Parliament  and  the 
Council to take note of this report. 

26 Commission Delegated Regulation (EU) 2023/439 of 16 December 2022 amending the Annex to Regulation 
(EU)  No  609/2013  of  the  European  Parliament  and  of  the  Council  to  allow  the  use  of  nicotinamide  riboside 
chloride as a source of niacin in food for special medical purposes and total diet replacement for weight control, 
OJ L 64, 1.3.2023, p. 1. 
27 Extension of use of nicotinamide riboside  chloride as a novel food pursuant to Regulation (EU) 2015/2283, 
https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2021.6843  
28 Commission Delegated Regulation (EU) …/... amending the Annex to Regulation (EU) No 609/2013 of the 
European Parliament and of the Council to allow the use of use of iron milk caseinate as a source of iron in total 
diet replacement for weight control and food for special medical purposes 
29 Safety of iron milk proteinate as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of 
iron 
2002/46/EC, 
https://www.efsa.europa.eu/en/efsajournal/pub/7549  

Directive 

context 

source 

from 

this 

the 

of 

in 

6