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: 2017-08-22
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: baby food, consumer information, delegated legislation, dietary product, food safety, foodstuff, labelling, marketing standard, transfer of competence

EN 

   EN 

   EUROPEAN COMMISSION  Brussels, 22.8.2017  COM(2017) 438 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 and legal basis  

This  report  is  intended  to  meet  the  obligation  set  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. 
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. The report shall be drawn up not later than 9 
months before the end of the 5-year period of the delegation, running from 19 July 2013. The 
delegation of power shall be tacitly extended for periods of an identical duration, unless the 
European Parliament or the Council opposes such extension not later than 3 months before the 
end of each period.  

2.  Exercise of the delegation  

Article 18(2) of the Food for Specific Groups Regulation empowers the Commission to adopt 
delegated acts referred to in Article 11, Article 15(6) and Article 16(1) of that Regulation.  

2.1.  Article  11  of  the  Food  for  Specific  Groups  Regulation  requires  the  Commission  to  lay 
down by the means of delegated acts specific requirements for the following categories of 
food: infant formula and follow-on formula; processed cereal-based food and baby food; 
food  for  special  medical  purposes;  total  diet  replacement  for  weight  control.  Since  the 
entry into force of the Food for Specific Groups Regulation, the Commission has adopted 
four delegated acts accordingly: 

a)  a 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 feeding2. 

This  legal  act  was  adopted  on  25  September  2015  with  the  objective  to  update  the 
requirements for formulae intended for infants based on the latest scientific evidence. 

1 OJ L 181, 29.6.2013, p. 35. 
2  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. 

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It transferred the existing rules of Directive 2006/141/EC on infant formulae and follow-
on  formulae3  under  the  framework  of  the  Food  for  Specific  Groups  Regulation  and 
updated them as follows: 
With  respect  to  composition,  the  changes  compared  to  Directive  2006/141/EC  mainly 
related to specific amounts of certain macronutrients and micronutrients on the basis of 
the latest scientific evidence. 

With  respect  to  labelling,  some  changes  were  made,  mainly  to  ensure  consistency  with 
horizontal rules of 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 
(hereinafter  'the  Food  Information  Regulation')4,  taking  into  account  the  specificities  of 
the products. Rules on nutrition and health claims on infant formula were updated taking 
into  account  the  latest  scientific  advice.  The  notification  procedure  was  maintained  for 
infant formula and extended, in certain cases, to follow-on formula.  

With regard to the rules on pesticides the relevant provisions of Directive 2006/141/EC 
were taken over. The Regulation will apply from 22 February 2020.5 

b)  a  Commission  Delegated  Regulation  supplementing  the  Food  for  Specific  Groups 
Regulation  as  regards  the  specific  compositional  and  information  requirements  for 
processed cereal-based food and baby food6. 

This Delegated Regulation was adopted by the Commission on 25 September 2015 and 
intended  to  transfer  the  existing  rules  of  Directive  2006/125/EC  on  processed  cereal-
based foods and baby foods for infants and young children7 under the framework of the 
Food  for  Specific  Groups  Regulation,  with  minor  adaptations  to  the  labelling  rules,  to 
ensure consistency with horizontal rules of the Food Information Regulation, taking into 
account the specificities of the products.  

On  20  January  2016,  the  European  Parliament  adopted  a  Resolution8  objecting  to  the 
Delegated  Regulation.  The  European  Parliament  expressed  concerns  on 
the 
compositional requirements for processed cereal-based food and baby food (in particular 
with  respect  to  the  sugar  levels  in  the  products)  and  the  labelling  and  marketing 
requirements  for  these  products  (with  respect  to  the  provision  of  information  on  the 
introduction of complementary feeding before six months of age). 

3  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. 
4 OJ L 304, 22.11.2011, p. 18. 
5 Except in respect of infant formula and follow-on formula manufactured from protein hydrolysates, to which it 
shall apply from 22 February 2021. 
6 Commission Delegated Regulation (EU) …/...of 25.9.2015 supplementing Regulation (EU) No 609/2013 of the 
European Parliament and of the Council as regards the specific compositional and information requirements for 
processed cereal-based food and baby food, C(2015) 6507 final. 
7 Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for 
infants and young children, OJ L 339, 6.12.2006, p. 16. 
8 P8_TA(2016)0015 

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c)  a 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 purposes9. 

This  legal  act  was  adopted  on  25  September  2015  with  the  objective  to  transfer  the 
existing  rules  of  Commission  Directive  1999/21/EC  on  food  for  special  medical 
purposes10  under  the  new  framework  of  the  Food  for  Specific  Groups  Regulation,  to 
update them where relevant and to extend to food for special medical purposes for infants 
all rules on labelling, presentation, advertising and marketing applicable to formulae for 
healthy  infants  that  are  not  contrary  to  the  product's  intended  use.  The  Delegated 
Regulation also extended the rules on pesticides that apply to infant formula, follow-on 
formula, processed cereal-based food and baby food to food for special medical purposes 
for infants and young children.  

With  respect  to  labelling,  changes  made  to  the  currently  applicable  Directive  aimed  at 
ensuring  consistency  with  the  Food  Information  Regulation,  taking  into  account  the 
specificities  of  the  products,  and  increasing  legal  certainty  on  the  intended  use  of  the 
products. The use of nutrition and health claims on this type of food was prohibited. The 
Regulation will apply from 22 February 201911. 

d)  a  Commission  Delegated  Regulation  supplementing  the  Food  for  Specific  Groups 
Regulation as  regards the  specific compositional and information  requirements for total 
diet replacement for weight control12. 

This  Delegated  Regulation  was  adopted  by  the  Commission  on  2  June  2017  and  was 
submitted to the European Parliament and the Council for scrutiny.  The main objective 
of the legal act is to update the existing rules on total diet replacement for weight control 
of Commission Directive 1996/8/EC on foods intended for use in energy-restricted diets 
for weight reduction13 and to include in its scope products placed on the market with very 
low energy content in  order to  ensure safety and suitability for all products intended to 
replace the totality of the daily diet.  

9 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. 
10 Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes, OJ L 91, 
7.4.1999, p. 29. 
11  Except  in  respect  of  food  for  special  medical  purposes  developed  to  satisfy  the  nutritional  requirements  of 
infants, to which it shall apply from 22 February 2020. 
12 Commission Delegated Regulation (EU) …/... of 2.6.2017 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 and weight control, C(2017)3664 final. 
13 Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for 
weight reduction, OJ L 55, 6.3.1996, p. 22. 

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With  respect  to  labelling,  changes  were  made  to  ensure  consistency  with  the  Food 
Information Regulation, while taking into account the specificities of the products. Given 
the  particular  role  of  such  foods  in  the  diet  of  a  specific  group  of  consumers  the 
Regulation limited the possibility to make nutrition claims and forbade the use of health 
claims on this type of foods. A notification procedure was introduced in order to facilitate 
efficient monitoring of these products. The Regulation will apply 5 years after its entry 
into force.  

2.2. On the basis of Article 16(1) of the Food for Specific Groups Regulation the Commission 
adopted  a  Commission  Delegated  Regulation  amending  the  Annex  to  the  Food  for 
Specific  Groups  Regulation  as  regards  the  list  of  substances  that  may  be  added  to 
processed cereal-based food and baby food and to food for special medical purposes14.  

This delegated act was adopted by the Commission on 10 April 2017 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 ferrous bisglycinate, as a source of iron to processed cereal-
based  food  and  baby  food  and  of  calcium  phosphoryl  oligosaccharides,  as  a  source  of 
calcium to food intended for special medical purposes on the basis of EFSA’s advice15,16 
taking  into  account  technical  progress,  scientific  developments  and  protection  of 
consumers' health. 

2.3. On the basis of Article 15(6) of the Regulation a delegation of powers has been granted to 
add or remove a category of substances to the Annex to the Regulation, in order to take 
into account technical  progress, scientific developments or the protection of consumer's 
health.  So  far,  the  Commission  has  not  yet  invoked  this  legal  basis,  as  the  relevant 
conditions have not applied yet.  

3.  Conclusion  

The Food for Specific Groups Regulation has applied for a period of less than one year and it 
is not yet applicable in its entirety. So far, the Commission has adopted delegated acts on the 
specific compositional and information requirements for infant and follow-on formula and as 
regards requirements on information relating to infant and young child feeding and as regards 
the  specific  compositional  and  information  requirements  for  food  for  special  medical 
purposes.  A  delegated  act  on  the  specific  compositional  and  information  requirements  for 
processed cereal-based food and baby food was objected to by the European Parliament. The 

14 Commission Delegated Regulation (EU) 2017/1091 of 10.4.2017 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 
processed cereal-based food and baby food and to food for special medical purposes, OJ L 158, 21.6.2017, p. 5.  
15    EFSA  AFC  Panel  (EFSA  Scientific  Panel  on  food  additives,  flavourings,  processing  aids  and  materials  in 
contact with food), Opinion related to Ferrous bisglycinate as a source of iron for use in the manufacturing of 
foods and in food supplements, The EFSA Journal (2006) 299, 1-17. 
16    EFSA  ANS  Panel  (EFSA  Panel  on  Food  Additives  and  Nutrient  Sources  added  to  Food),  2016,  Scientific 
Opinion  on  Calcium  phosphoryl  oligosaccharides  (POs-Ca®)  as  a  source  of  calcium  added  for  nutritional 
purposes to food, food supplements and foods for special medical purposes, EFSA Journal 2016;14(6):4488. 

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delegated  act  on  the  specific  compositional  and  information  requirements  for  total  diet 
replacement  for  weight  control  was  adopted  by  the  Commission  on  2  June  2017  and  was 
submitted  to  the  European  Parliament  and  the  Council  for  scrutiny.  The  delegated  act 
amending  the  Annex  to  Regulation  (EU)  No  609/2013  as  regards  the list  of  substances  that 
may be added to processed cereal-based food and baby food and to food for special medical 
purposes was adopted by the Commission on 10 April 2017. 

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