EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10355/2015 
(POOL/E4/2015/10355/10355-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION DELEGATED REGULATION (EU) …/... 
of XXX  
supplementing Regulation (EU) No 609/2013 of the Europe an Parliament and of the 
Council as regards the specific composit ional and information requirements for 
processed cereal-based food and baby food 
(Text with EEA relevance) 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT 
Regulation (EU) No 609/2013 of the Europe an 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
1 repeals Directive 
2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for part icular nutritional uses
2 from 20 July 2016. Article 11 of 
the Regulation empowers the European Co mmission to adopt delegated acts laying 
down specific compositional and information requirements for the foods under its scope. These delegated acts sh all be adopted by 20 July 201 5. The relevant foods are: 
• Infant formula and follow-on formula; 
• Processed cereal-based food and baby food; 
• Food for special medical purposes; 
• Total diet replacement for weight control. 
Recital 27 of the Regulation requires the Commission to take into account, when 
adopting such rules, Commission Direct ives 1996/8/EC of 26 February 1996 on 
foods intended for use in energy-re stricted diets fo r weight reduction
3, 1999/21/EC 
of 25 March 1999 on dietary foods  for special medical purposes4, 2006/125/EC of 
5 December 2006 on processed cereal-based foods and baby foods for infants and 
young children5 and 2006/141/EC of 22 December 2006 on infant formulae and 
follow-on formulae6, which lay down rules for the abovementioned foods today.  
Article 20(4) of the Regulation foresees that the existing Commission Directives are 
repealed from the date of application of the delegated acts adopted by the Commission. 
This delegated Regulation transfers th e existing rules of Commission Directive 
2006/125/EC on processed cereal-based foods  and baby foods for infants and young 
children under the new fr amework of Regulation (EU) No 609/2013 and updates 
them where relevant on the basis of th e consultations described in point 2. 
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
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 control7, which met on the subject on 15 May and 
13 September 2013, and 18 February 2015. 
NGOs and other stakeholders were consulte d in the context of the Advisory Group 
on the Food Chain and An imal and Plant Health8, which held a Working Group on 
the subject on 17 February 2015. The possibi lity to provide wr itten comments was 
                                                 
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 OJ L 91, 7.4.1999, p. 29. 
5 OJ L 339, 6.12.2006, p. 16. 
6 OJ L 401, 30.12.2006, p. 1. 
7 Reference E02893 in the Register of Commission Expert Groups and other similar entities. 
8 Reference E00860 in the Register of Commission Expert Groups and other similar entities.  
EN 3   EN 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 Delegated Regulation intends to incorporate the existing rules of Directive 
2006/125/EC. Only minor adaptations are fores een to the labelling rules, to ensure 
consistency with horizontal rules of Regul ation (EU) No 1169/2011 of the European 
Parliament and of the Council of 25 October 2011 on the provision of food information to consumers
9, taking into account the speci ficities of the products. 
Following the request of Member States  and food business operators, the Annex 
containing daily reference intakes for vita mins and minerals for food intended for 
infants and young children is updated to ensure  consistency with ru les applicable to 
infant formula and follow-on formula. 
The application of the delegated Regula tion is deferred to allow food business 
operators to adapt to the technical changes. 
                                                 
9 OJ L 304, 22.11.2011, p. 18.  
EN 4   EN COMMISSION DELEGATED RE GULATION (EU) …/... 
of XXX  
supplementing Regulation (EU) No 609/2013 of  the European Parliament and of the 
Council as regards the specific composit ional and information requirements for 
processed cereal-based food and baby food 
(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, Comm ission Directives 96/8/EC , 1999/21/EC, 2006/125/EC and 
2006/141/EC, Directive 2009/39/EC of the Europ ean Parliament and of the Council and 
Commission Regulations (EC) No 41/2009 and (EC) No 953/2009
10, and in particular 
Article 11(1) thereof, 
Whereas: (1) Commission Directive 2006/125/EC
11 lays down harmonised rules on processed 
cereal-based food and baby food in the fram ework of Directive 2009/39/EC of the 
European Parliament and of the Council12. 
(2) Directives 2009/39/EC and 2006/125/EC are repealed by Regulation (EU) 
No 609/2013. That Regulation lays down general compositional and information requirements for different categories of f ood, including processed cereal-based food 
and baby food. The Commission has to adopt specific compositional and information 
requirements for processed cereal-based food and baby food, taking into account the 
provisions of Directive 2006/125/EC. 
(3) Processed cereal-based food and baby food are used by infants and young children as 
part of a diversified diet and do not constitute  the sole source of nourishment of infants 
and young children.  
(4) The essential composition of processed cereal-based food and baby food should be 
appropriate for the nutritional requirements of infants and young children in good health as established by generally accepted scientific data. 
(5) Owing to social and cultural circumstances existing in the Union, there is a great 
variety of processed cereal-based food and baby food, which reflects the widely varied 
diet of infants being weaned and young childre n. It is therefore not  appropriate to lay 
down detailed compositional rules for these foods. 
                                                
 
10 OJ L 181, 29.6.2013, p. 35. 
11 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). 
12 Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs 
intended for particular nutritional uses (OJ L 124, 20.5.2009, p. 21).  
EN 5   EN (6) The nature and destination of processed cereal-based food and baby food require the 
establishment of a number of specific compositional requirements and restrictions concerning the content of vitamins, minerals and other nutrients pr esent in the product 
or added to it. Such rules should be based on those of Directive 2006/125/EC, given 
that they have ensured an adequate fr amework for processed cereal-based food and 
baby food so far.  
(7) Pursuant to Regulation (EU) No 609/2013, th e Commission has to adopt provisions 
restricting or prohibiting th e use of pesticides and on pe sticide residues in processed 
cereal-based food and baby food, taking account of those currently established in the 
Annexes to Directive 2006/125/EC. Adopting provisions that are in line with the 
current scientific knowledge requires a si gnificant amount of time, given that a 
comprehensive evaluation has to be car ried out by the Eur opean Food Safety 
Authority on a number of aspects, includi ng the appropriateness of  the toxicological 
reference values for infants and young child ren. Taking into account the date of 20 
July 2015 set by Regulation (EU) No 609/2013 for the adoption of this Delegated 
Regulation, the relevant existing requirements of Di rective 2006/125/EC should, at 
this stage, be taken over. However, it is appropriate to us e the terminology of 
Regulation (EC) No 1107/2009 of the Eur opean Parliament and of the Council
13. 
(8) Directive 2006/125/EC lays down specific requ irements on the use of pesticides in 
products intended for the production of pr ocessed cereal-based food and baby food 
and on pesticide residues in such food, based on two opinions given by the Scientific 
Committee for Food (SCF) on 19 September 199714 and 4 June 199815.  
(9) A very low residue limit of 0,01 mg/kg for al l pesticides is set on the basis of the 
precautionary principle. In addition, more se vere limitations are set for a small number 
of pesticides or metabolites of pesticid es for which even a maximum residue level 
(MRL) of 0,01 mg/kg might, under worst-case intake conditi ons, lead to an exposure 
exceeding the acceptable daily intake (ADI) for infants and young children.  
(10) A prohibition of the use of certain pesticides would not necessari ly guarantee that 
processed cereal-based food and baby food ar e free from those pesticides, since some 
pesticides are persistent in the environm ent and their residues can be found in the 
food. For that reason, those pestic ides are considered not to ha ve been used if residues 
are below a certain level.  
(11) Processed cereal-based food and baby food have to comply with Regulation (EU) 
No 1169/2011 of the European Pa rliament and of the Council16. In order to take 
account of the specific nature of proce ssed cereal-based food and baby food, this 
                                                 
13 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 
14 Opinion of the Scientific Committee for Food on a maximum residue limit (MRL) of 0.01 mg/kg for 
pesticides in foods intended for infants and young children (expressed on the 19th September 1997). 
15 Further advice on the opinion of the Scientific Committee for Food expressed on the 19 September 
1997 on a Maximum Residue Limit (MRL) of 0.01 mg/Kg for pesticides in foods intended for infants 
and young children (adopted by the SCF on 4 June 1998). 
16 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 Directive 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 Regulation should lay down additions and exce ptions to those ge neral rules, where 
appropriate.  
(12) Providing all information that is necessary to  ensure the appropriate use of processed 
cereal-based food and baby food should be manda tory for this type  of food, including 
information on the age from which the product may be used. 
(13) The nutrition declaration for processed cerea l-based food and baby food is important 
to guarantee the appropriate use of the products. For that reas on and in order to 
provide more complete information, the nutrition declaration should include more 
particulars than those required by Regul ation (EU) No 1169/2011. In addition, the 
exemption provided for in point 18 of Annex V to Regulati on (EU) No 1169/2011 
should not apply and the nutrition declaration should be mandatory for all processed cereal-based food and baby food, irrespectiv e of the package or container size. 
(14) Article 30(2) of Regulation (E U) No 1169/2011 contains a lim ited list of nutrients that 
may be included on a voluntary basis in th e nutrition declaration for food. The Annex 
to Regulation (EU) No 609/2013 lists a series  of substances that may be added to 
processed cereal-based food and baby food and some of them are not covered by 
Article 30(2) of Regulation (EU) No 1169/201 1. In order to ensure legal clarity, it 
should be laid down explicitly that the nutrition declarati on for processed cereal-based 
food and baby food may include such substances.  
(15) Healthy infants and young children have diffe rent nutritional needs than adults. The 
expression of nutrition information on the ener gy value and the amount of nutrients of 
processed cereal-based food and baby food as a percentage of daily  reference intake 
values set out for the general adult population in Regulation (EU) No 1169/2011 would mislead consumers and should therefor e not be allowed. For that reason, and in 
order to ensure comparisons with other foods that can be included in the diet of infants 
and young children, for processed cereal-ba sed food and baby food it should be 
allowed to express the amounts of vitamins a nd minerals as a per centage of specific 
reference intakes that are a ppropriate for the ag e group, provided that the substances 
are present in significant amounts in the product.  
(16) Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the 
Council
17 requires Member States to enforce f ood law, and monitor and verify that the 
relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and di stribution. In this c ontext, the national 
competent authorities may request food bus iness operators placing processed cereal-
based food and baby food on the market to pr ovide all relevant in formation considered 
necessary to demonstrate comp liance with this Regulation. 
(17) In order to enable food business operators to adapt to the new requirements, this 
Regulation should apply from a date that is three years af ter its entry into force,  
HAS ADOPTED THIS REGULATION: 
                                                
 
17 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
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 Article 1 
Placing on the market 
Processed-cereal based food and baby food may onl y be placed on the market if they comply 
with this Regulation.  
Article 2 
Compositional requirements 
1. Processed cereal-based food and baby food shall be manufactured from ingredients 
whose suitability for infant s and young children has been  established by generally 
accepted scientific data. 
2. Processed cereal-based food shall comply  with the compositional requirements set 
out in Annex I.  
3. Baby food referred to in Annex II shall co mply with the compositional requirements 
set out in that Annex. 
4. The compositional requirements concerning nutrients set out in Annexes I and II 
shall apply to the processed cereal-based food and baby food ready for use, marketed 
as such or after preparation in accordan ce with the manufactur er's instructions. 
Article 3 
Requirements on pesticides 
1. For the purposes of this Ar ticle, ‘residue’ means the residue  of an active substance as 
referred to in Article 2( 2) of Regulation (EC) No 1107/2009 used in a plant 
protection product as referre d to in Article 2(1) of  that Regulation, including 
metabolites and products resulting from the degradation or reac tion of that active 
substance. 
2. Processed cereal-based food and baby food shall not contain re sidues at levels 
exceeding 0,01 mg/kg per active substance. 
Those levels shall be determined by generally accepted standardised analytical 
methods. 
3. By way of derogation from paragraph 2, for the active substances listed in Annex III, 
the maximum residue levels specif ied in that Annex shall apply. 
4. Processed cereal-based food and baby food shall only be produced from agricultural 
products for the production of which plant protection products c ontaining the active 
substances listed in Annex IV have not been used. 
However, for the purpose of checks, plant protection products co ntaining the active 
substances listed in Annex IV are considered  not to have been us ed if their residues 
do not exceed a level of 0,003 mg/kg. 
5. The levels referred to in paragraphs 2, 3 and 4 shall apply to the processed cereal-
based food and baby food ready for use, mark eted as such or after preparation in 
accordance with the manufacturer's instructions.  
EN 8   EN Article 4 
 Specific requirements on food information  
1. Unless otherwise provided in this Regulat ion, processed cereal-ba sed food and baby 
food shall comply with Re gulation (EU) No 1169/2011. 
2. 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 processed cereal-based food and baby food:  
(a) a statement as to the appropriate age from which the product may be used, 
regard being had to its co mposition, texture or other pa rticular properties. The 
stated age shall not be less than four months for any product. Products 
recommended for use from the age of f our months may indicate that they are 
suitable from that age unless independe nt persons having qualifications in 
medicine, nutrition or pharmacy, or ot her professionals responsible for 
maternal and child care, advise otherwise; 
(b) information as to the presence of gluten  if the indicated age from which the 
product may be used is below six months;  
(c) instructions for appropriate preparation, where necessary, and a statement as to 
the importance of following those instructions. 
3. Article 13(2) and (3) of Regulation (E U) No 1169/2011 shall also apply to the 
additional mandatory particulars referred to in paragraph 2 of this Article.  
Article 5 
Specific requirements on the nutrition declaration 
1. In addition to the information referred to in Article 30(1) of Regulation (EU) 
No 1169/2011, the mandatory nutrition declar ation for processed cereal-based food 
and baby food shall include the amount of  each mineral substance and of each 
vitamin listed in Annex I or Annex II to th is Regulation respectiv ely and present in 
the product, with the exception of sodium. 
2. In addition to the informati on referred to in Article 30(2 )(a) to (e) of Regulation (EU) 
No 1169/2011, the content of the mandatory  nutrition declaration for processed 
cereal-based food and baby food may be suppl emented with the amounts of any of 
the substances listed in the Annex to  Regulation (EU) No 609/2013, where such 
indication is not covered by pa ragraph 1 of this Article. 
3. By way of derogation from Article 30( 3) of Regulation (EU) No 1169/2011, the 
information included in the mandatory nut rition declaration for processed cereal-
based food and baby food shall not be repeated on the labelling. 
4. The nutrition declaration shall be mandato ry for all processed cereal-based food and 
baby food, irrespective of the size of th e largest surface of the packaging or 
container.  
5. Articles 31 to 35 of Regulation (EU) No 1169/2011 shall apply to all the nutrients 
included in the nutrition declaration for processed cereal-based food and baby food.  
6. By way of derogation from Article 32( 3) and (4) of Regulation (EU) No 1169/2011, 
the energy value and the amount of nutrien ts of processed cereal-based food and 
baby food shall not be expressed as a percen tage of the reference intakes set out in 
Annex XIII to that Regulation.   
EN 9   EN In addition to the form of expression refe rred to in Article 32(2) of Regulation (EU) 
No 1169/2011, the declaration on vitamins and minerals in respect of the vitamins 
and minerals listed in Annex V to this Re gulation may be expressed as a percentage 
of the reference intakes set out  in that Annex in  relation to per 100 g or per 100 ml of 
the food. Where no minimum levels are set fo r those vitamins and minerals in Annex 
I or Annex II to this Regulation, the expr ession as a percentage of the reference 
intakes shall be allowed provi ded that the quantities presen t are at least equal to 15% 
of the reference intakes laid dow n in Annex V to this Regulation. 
7. The particulars included in the nutrition d eclaration for processed cereal-based food 
and baby food that are not listed in A nnex 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 compone nts of any of the entries of that Annex shall be 
presented in the nutrition declaration after the last entry of that Annex.  
Article 6 
References to Directive 2006/125/EC 
From [same date as in the second paragraph of Article 7] references to Directive 2006/125/EC 
in other acts shall be construed as  references to this Regulation. 
Article 7 
Entry into force and application 
This Regulation shall enter into force on the [… ] day following that of its publication in the 
Official Journal of the European Union . 
It shall apply from [3 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