EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10354/2015 
(POOL/E4/2015/10345/10345-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 specifi c compositional and informat ion requirements for infant 
formula and follow-on formula and as regards requirements on information relating to 
infant and young child feeding 
(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repealed from the date of application of the delegated acts adopted by the Commission.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 
2006/141/EC on infant formulae and follow- on formulae under the new framework 
of Regulation (EU) No 609/2013 and updates th em where relevant on the basis of the 
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 infant and follow-
on formulae7 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 
                                                 
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 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014, Scientific Opinion 
on the essential composition of infant and follow-on formulae. EFSA Journal 2014;12(7):3760.  
EN 3   EN diet replacement for weight control8, which met on the subject on 15 May and 
30 October 2013, 14 July 2014 and 2 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 Health9, which held a Working Group on 
the subject on 17 February 2015. The possibi lity to provide wr itten 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 
With respect to composition, the propos ed changes compared to Directive 
2006/141/EC mainly relate to specific amounts of certain macronutrients and 
micronutrients that are either increased or  reduced on the basis of EFSA's advice. 
Following EFSA's advice, DocosaHexaenoi c Acid (DHA, an omega-3 fatty acid) 
will be required to be added to all formulae (before, it could be added on a voluntary basis) and formulae from protein hydrolys ates will be assessed on a case-by-case 
basis. 
With respect to labelling, some changes are proposed, 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 th e provision of food information to 
consumers
10, taking into account the specificities of the pr oducts. Other provisions 
on labelling, presentation and advertising are not changed (unless where these were 
changed by Regulation (EU) No 609/2013). 
Rules on nutrition and health claims on infant formula are updated taking into 
account EFSA's advice. The notification pro cedure is maintained for infant formula 
and added, in certain cases, to follow-on fo rmula (Member States can derogate from 
this new provision if they do not consider it necessary). Rules on pesticides will be transferred as they are t oday and will be updated in the future based on updated 
scientific advice from EFSA. 
The application of the delegated Regula tion is deferred to allow food business 
operators to adapt to the technical changes. 
                                                
 
8 Reference E02893 in the Register of Commission Expert Groups and other similar entities. 
9 Reference E00860 in the Register of Commission Expert Groups and other similar entities. 
10 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 compositiona l and information requirements for infant 
formula and follow-on formula and as regards requirements on information relating to 
infant and young child feeding 
(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
11, and in particular 
Article 11(1) thereof, 
Whereas: (1) Commission Directive 2006/141/EC
12 lays down harmonised rules on infant formula 
and follow-on formula in the framework of  Directive 2009/39/EC of the European 
Parliament and of the Council13. 
(2) Directives 2009/39/EC and 2006/141/EC are repealed by Regulation (EU) 
No 609/2013. That Regulation lays down general compositional and information requirements for different categories of food, including infant formula and follow-on 
formula. The Commission has to adopt specific compositional and information requirements for infant formula and follo w-on formula, taking into account the 
provisions of Directive 2006/141/EC. 
(3) Infant formula is the only processed foodstu ff which wholly satisfies the nutritional 
requirements of infants during the first months of life until the introduction of 
appropriate complementary feeding. In order to safeguard the health of those infants, it 
is necessary to ensure that infant formul a is the only product marketed as suitable for 
such use during that period. 
(4) The essential composition of infant formul a and follow-on formula must satisfy the 
nutritional requirements of infants in good h ealth as established by generally accepted 
scientific data.  
                                                
 
11 OJ L 181, 29.6.2013, p. 35. 
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). 
13 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 (5) Infant formula and follow-on formula are sophisticated products that are specially 
formulated for a vulnerable group of consumers. In order to ensure the safety and suitability of such products, detailed re quirements should be laid down on the 
composition of infant formula and follow-on formula, including requirements on energy value, macronutrient and micronutrien t content. These requirements should be 
based on the latest scientific advice of the European Food Safety Authority ('the 
Authority') in its opinion on the essentia l composition of infant and follow-on 
formulae
14.  
(6) In order to ensure innovation and product development, the voluntary addition to 
infant formula and follow-on formula of  ingredients not covered by specific 
requirements of this Regulation should be possible. All ingredients used in the 
manufacture of infant formula and follow- on formula should be suitable for infants 
and their suitability should have been de monstrated, when necessary, by appropriate 
studies. It is the responsibility of f ood business operators to demonstrate such 
suitability and of national competent authorities to consider, on a case by case basis, whether this is the case. Guidance on the design and conduct of a ppropriate studies has 
been published by expert scientific groups such as the Scientific Committee on Food, 
the UK Committee on the Medical Aspects of Food and Nutrition Policy, and the European Society for Paediatric Gastro enterology, Hepatology and Nutrition. Such 
guidance should be taken into consideration in the manufacturing of infant formula or 
follow-on formula. 
(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 infant 
formula and follow-on formula, taking account of those currently established in the 
Annexes to Directive 2006/141/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 carri ed out by the Author ity on a number of 
aspects, including the appropria teness of the toxicological reference values for infants 
and young children. 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 Directive 2006/141/EC should, at  this stage, be taken over. However, 
it is appropriate to use the terminology of Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council
15. 
(8) Directive 2006/141/EC lays down specific requ irements on the use of pesticides in 
products intended for the production of infa nt formula and follow-on formula and on 
pesticide residues in such food, based on two opinions given by  the Scientific 
Committee for Food (SCF) on 19 September 199716 and 4 June 199817.  
(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 
                                                 
14 EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion 
on the essential composition of infant and follow-on formulae. EFSA Journal 2014;12(7):3760. 
15 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). 
16 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). 
17 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).  
EN 6   EN 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 
infant formula and follow-on formula are 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) Infant formula and follow-on formula have to comply with Regulation (EU) 
No 1169/2011 of the European Pa rliament and of the Council18. In order to take 
account of the specific nature of infant fo rmula and follow-on formula and in order to 
promote and protect breast feeding, this  Regulation should lay down additions and 
exceptions to those general rules, where appropriate. 
(12) Given the particular role of infant formula and follow-on formula in the diet of infants, 
it is important to ensure that products  exported to third countries provide food 
information in a language easily understood by parents and caregivers, in the absence 
of specific relevant provisions establishe d by or agreed with the importing country. 
(13) Given the different role of infant formula a nd follow-on formula in th e diet of infants, 
it is appropriate to lay down provisions requi ring that a clear distinction can be made 
between them, so as to avoid any risk of confusion. 
(14) The nutrition declaration for infant formula and follow-on formula is essential in order 
to guarantee their appropriate use, both for parents and caregivers and for health care professionals who recommend their consump tion. For that reason 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 nutri tion declaration should be mandatory for all infant 
formula and follow-on formula, irrespectiv e of the package or container size.  
(15) 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 the nutrition declaration fo r food. That Article 
does not cover all the substan ces that may be added to in fant formula and follow-on 
formula. In order to ensure legal clarity, it should be laid down explicitly that the 
nutrition declaration for infant formula and follow-on formula may include such 
substances. In addition, in certain cases , more detailed information on protein, 
carbohydrate and fat present in the product could provide additional useful information for parents, caregivers and healthcare professionals. Food business operators should therefore be allowed to  provide such information on a voluntary 
basis.  
(16) In order to facilitate produc t comparisons, the nutrition declaration for infant formula 
and follow-on formula should be expressed per 100 ml of the product ready for use 
after preparation in accordance with the manufacturer's instructions.  
                                                
 
18 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 7   EN (17) Infant formula is a food intended for use by infants during the first months of life and 
satisfying by itself the nutritional requirements of such infants until the introduction of 
appropriate complementary feeding. The expression of nutriti on information on the 
energy value and the amount of nutrients of infant formula as a percentage of daily 
reference intake values would mislead cons umers and should therefore not be allowed. 
Follow-on formula is, on the contrary, a food intended for use by infants when 
appropriate complementary feeding is intr oduced and which constitutes the principal 
liquid element in a progressively diversified diet of such infants.  For that reason, and 
in order to ensure comparisons with other foods  that can be included in the diet of such 
infants, the expression of nutrition informa tion for follow-on formula as a percentage 
of daily reference intake va lues should be allo wed. Given that healthy infants have 
different nutritional needs than adults, the us e of daily reference intake values set out 
for the general adult population in Re gulation (EU) No 1169/2011 would mislead 
consumers and should therefore not be a llowed. For follow-on formula it should only 
be allowed to express nutrition information as a percentage of specific reference 
intakes that are appropriate for the age group.  
(18) Nutrition and health claims are promotiona l tools that are used on a voluntary basis by 
food business operators in commercial co mmunication, in line wi th the rules of 
Regulation (EC) No 1924/2006 of the Eur opean Parliament and of the Council19. 
Given the particular role of infant formula in  the diet of infants, the use of nutrition 
and health claims should not be allowed for infant formula. 
(19) Statements relating to the presence or absenc e of lactose in infant formula and follow-
on formula can provide useful information to parents and caregivers. Therefore, it is 
appropriate to lay down rules on such stat ements, which might be reviewed taking 
account of future developments on the market. 
(20) The mandatory addition of docosahexaenoic acid (DHA) to infant formula and follow-
on formula is a new requirement introduced by this Regulation, as recently 
recommended by the Authority in its opinion on the essential composition of infant and follow-on formulae. Given that the a ddition of DHA was allowed on a voluntary 
basis under Directive 2006/141/EC, and pare nts and caregivers are familiar with the 
nutrition claim about the presence of DHA in  infant formula, the use of which was 
permitted under that Directive, food busines s operators should be allowed to continue 
to refer to the presence of DHA in infant formula by a statement provided for in this 
Regulation for a limited period of time in order to avoid confusion. However, it is 
important that that statement provides full information to consumers about the 
mandatory presence of DHA in all infant formula products on the market. 
(21) The use of protein hydrolysates as a source of protein in infant formula and follow-on 
formula has been allowed under Directive 2006/141/EC for many y ears and the use of 
protein hydrolysates in the manu facturing of formula is wide spread in the market. This 
is due, in particular, to the possibility, rec ognised by that Directive, to make a health 
claim on infant formula manufactured from pr otein hydrolysates describing the role of 
such formula in reducing the risk of devel oping allergy to milk proteins, under certain 
conditions laid down in that Directive. In  its opinion on the essential composition of 
infant and follow-on formulae, the Authority noted that the safety and suitability of 
each specific formula containing protein hydrol ysates has to be established by clinical 
evaluation and that only one formula contai ning partially hydrolysed whey protein has 
                                                
 
19 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on 
nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9).  
EN 8   EN been positively evaluated so far. The Author ity also noted that clinical studies are 
necessary to demonstrate if an d to what extent a particular  formula reduces the risk of 
developing short and long-term clinical manifestations of a llergy in at-risk-infants who 
are not breast-fed. Taking into account the Authority’s opinion, infant formula and 
follow-on formula manufactured from protein hydrolysates should only be allowed to 
be placed on the market if their composition corresponds to the requirements of this Regulation. Those requirements may be update d in order to allow the placing on the 
market of formula manufactured from protein hydrolysates with a composition 
different from the one already positively assessed, following a case-by-case evaluation 
of their safety and suitabili ty by the Authority. In additi on, after the assessment by the 
Authority, on the basis of studies, where it is demonstrated that a specific formula 
manufactured from protein hydrolysates reduces  the risk of developing allergy to milk 
proteins, further consideration will be given to how to adequately inform parents and 
caregivers about that pr operty of the product. 
(22) Regulation (EU) No 609/2013 provides that th e labelling, presenta tion and advertising 
of infant formula and follow-on formula is to be designed so as not to discourage 
breastfeeding. There is scientif ic consensus that breast milk is the preferred food for 
healthy infants and the Union and its Memb er States are continuously committed to 
supporting breastfeeding. The conclusions adopted by the Council on nutrition and 
physical activity
20 invited Member States to promote and support adequate 
breastfeeding and welcomed the Member States’ agreement on an EU Action Plan on Childhood Obesity 2014-2020, which includes a se ries of actions aimed at increasing 
breastfeeding rates in the Union. In this context, th e EU Action Plan recognised the 
continuous importance of the World Health  Organisation (WHO) International Code 
of Marketing of Breast-milk  Substitutes, on which Dire ctive 2006/141/EC was based. 
The WHO Code, adopted by the 34th World He alth Assembly, aims at contributing to 
the provision of safe and adequate nut rition for infants, by the protection and 
promotion of breast-feeding, a nd by ensuring the proper use of  breast-milk substitutes. 
It includes a series of prin ciples related to, among others, marketing, information and 
responsibilities of health authorities. 
(23) In order to protect the health of infants, the rules laid down in this Regulation and in 
particular those on labelling, presentati on and advertising, and promotional and 
commercial practices should continue being in  conformity with the principles and the 
aims of the International Code of Market ing of Breast-milk Substitutes bearing in 
mind the particular legal and factual situa tion existing in the Union. In particular, 
evidence shows that advertis ing directly to the cons umer and other marketing 
techniques influence parents and caregivers in their deci sions on how to feed their 
infants. For this reason, and taking into account the particular role of infant formula in 
the diet of infants, specific restrictions should be laid down in this Regulation on 
advertising and other marketing techniques fo r this type of product. However, this 
Regulation should not concern the conditions of  sale of publicati ons specialising in 
baby care and of scie ntific publications. 
(24) In addition, information given on infant an d young child feeding influences pregnant 
women, parents and caregivers when choosing the type of nourishment for children. It 
is therefore necessary to la y down requirements in order th at such information ensures 
an adequate use of the produc ts in question and is not counter to the promotion of 
breast feeding, in line with the principles  of the WHO code. 
                                                
 
20 OJ C 213, 8.7.2014, p. 1.  
EN 9   EN (25) Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the 
Council21 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 dist ribution. In this context, in order to 
facilitate the efficient offi cial monitoring of infant formula and follow-on formula, 
food business operators placing infant fo rmula on the market should provide the 
national competent authorities with a model of the label used and all relevant information considered necessary to demons trate compliance with this Regulation. A 
similar obligation should apply in respect of certain types of follow-on formula, unless 
Member States have a different  efficient monitoring system.  
(26) In order to enable food business operators to adapt to the new requirements, this 
Regulation should apply from a da te that is four years after its entry into force. Taking 
into account the number and importance of th e new requirements applicable to infant 
formula and follow-on formula manufactured from protein hydrolysat es, in respect of 
such products this Regulation should apply from  a date that is five  years after its entry 
into force,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Placing on the market 
1. Infant formula and follow-on formula may only be placed on the market if they 
comply with this Regulation. 
2. No product other than infant formula may be marketed or otherwise represented as 
suitable for satisfying by itself the nutriti onal requirements of normal healthy infants 
during the first months of life until the introduction of appropr iate complementary 
feeding. 
Article 2 
Compositional requirements 
1. Infant formula shall comply with the co mpositional requirements set out in Annex I 
taking into account the values for the in dispensable and conditionally indispensable 
amino acids set out in Annex III. 
2. Follow-on formula shall comply with th e compositional requirements set out in 
Annex II taking into account the values for the indispensable and conditionally 
indispensable amino acids set out in Annex III.  
3. The values set out in Annexe s I and II shall apply to the infant formula and follow-on 
formula ready for use, marketed as such or after preparation in accordance with the 
manufacturer's instructions. For such prep aration nothing more than the addition of 
water shall be required. 
                                                
 
21 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 10   EN Article 3 
Suitability of ingredients 
1. Infant formula shall be manufactured from protein sources as se t out in point 2 of 
Annex I and other food ingredients, as the case may be, whose suitability for infants 
from birth has been established by ge nerally accepted scientific data.  
2. Follow-on formula shall be manufactured from  protein sources as set out in point 2 
of Annex II and other food ingredients, as  the case may be, whose suitability for 
infants aged over six months has been es tablished by generally accepted scientific 
data. 
3. The suitability referred to in paragraphs  1 and 2 shall be demonstrated by the food 
business operator through a systematic revi ew of the available data relating to the 
expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the 
design and conduct of such studies. 
Article 4 
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 Regul ation (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. Infant formula and follow-on formula shal l not contain residues 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 IV, 
the maximum residue levels specif ied in that Annex shall apply. 
4. Infant formula and follow-on formula sh all only be produced from agricultural 
products for the production of which plant protection products c ontaining the active 
substances listed in Annex V have not been used. 
However, for the purpose of checks, plant protection products co ntaining the active 
substances listed in Annex V are considered not to have been used 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 infant formula and 
follow-on formula ready for use, marketed as  such or after preparation in accordance 
with the manufacturer's instructions. 
Article 5 
Name of the food 
1. The name of infant formula and follow- on formula other than infant formula and 
follow-on formula manufactured entirely from  cows' milk or goats' milk proteins 
shall be as set out in Part A of Annex VI. 
2. The name of infant formula and follow-on formula manufactured entirely from cows’ 
milk or goats’ milk proteins shall be  as set out in Pa rt B of Annex VI.  
EN 11   EN Article 6 
Specific requirements on food information 
1. Unless otherwise provided in this Regulation, infant formula and follow-on formula 
shall comply with Regulation (EU) No 1169/2011.  
2. In addition to the mandatory particulars list ed in Article 9(1) of Regulation (EU) No 
1169/2011, the following shall be additional mandatory particulars for infant 
formula: 
(a) a statement that the product is suitable for infants from birth when they are not 
breast fed; 
(b) instructions for appropriate preparati on, storage and disposal  of the product and 
a warning against the health hazards of inappropriate preparation and storage; 
(c) a statement concerning the superiority of breast feeding and a statement 
recommending that the product be used  only on the advice of independent 
persons having qualifications in medici ne, nutrition or pharmacy, or other 
professionals responsible for maternal and child care. The particulars referred 
to in this point shall be preceded by the words ‘important notice’ or their equivalent and shall be given also in th e presentation and advertising of infant 
formula. 
3. 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 follow-on formula: 
(a) a statement that the product is suitable  only for infants over the age of six 
months, that it should form only part of a diversified diet, that it is not to be 
used as a substitute for breast milk during the first six months of life and that the decision to begin complementary feeding, including any exception to six months of age, should be made only on the advice of independent persons 
having qualifications in medi cine, nutrition or pharmac y, or other professionals 
responsible for maternal and child car e, based on the individual infant’s 
specific growth and development needs; 
(b) instructions for appropriate preparati on, storage and disposal  of the product and 
a warning against the health hazards of inappropriate preparation and storage. 
4. Article 13(2) and (3) of Regulation (E U) No 1169/2011 shall also apply to the 
additional mandatory particulars referred to in paragraphs 2 and 3 of this Article.  
5. All mandatory particulars for infant form ula and follow-on formula shall appear in a 
language easily understood by the consumers. 
6. The labelling, presentation and advertisi ng of infant formula and follow-on formula 
shall provide the necessary information about  the appropriate use of the products, so 
as not to discourage breast feeding. 
The labelling, presentation and advertising of infant formula and follow-on formula 
shall not use the terms ‘humanised’, ‘mater nalised’, ‘adapted’, or terms similar to 
them. 
The labelling, presentation and advertising of infant formula and follow-on formula 
shall be designed in such a way that it avoids any risk of confusion between infant formula and follow-on formula and enables consumers to make a clear distinction between them, in particular as to the text, images and colours used.  
EN 12   EN Article 7 
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 declaration for infant formula and follow-on formula shall include the amount of each mineral substance and of each vitamin 
listed in Annex I or Annex II to this Re gulation respectively and present in the 
product, with the exception of molybdenum. 
The mandatory nutrition declaration for infa nt formula shall also include the amount 
of choline, inositol and carnitine. 
By way of derogation from Article 30( 1) of Regulation (EU) No 1169/2011, the 
mandatory nutrition declaration for infant formula and follow-on formula shall not 
include the amount of salt. 
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 nu trition declaration for infant formula 
and follow-on formula may be supplemented with one or more of the following: 
(a) the amounts of components of  protein, carbohydrate or fat; 
(b) the whey protein/casein ratio; (c) the amount of any of the substances listed in Annex I or  Annex II to this 
Regulation or in the Annex to Re gulation (EU) No 609/2013, where the 
indication of any of those substances  is not covered by paragraph 1;  
(d) the amount of any of the substances added to the product pursuant to Article 3. 
3. By way of derogation from Article 30( 3) of Regulation (EU) No 1169/2011, the 
information included in the mandatory nutri tion declaration for infant formula and 
follow-on formula shall not be repeated on the labelling.  
4. The nutrition declaration shall be mandato ry for all infant formula and follow-on 
formula, irrespective of the size of the larg est 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 infant formula and follow-on formula.  
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 infant formula and 
follow-on formula shall be expressed per 100 ml of the food ready for use after preparation in accordance with  the manufacturer's instru ctions. Where appropriate, 
the information may in addition refer to 100 g 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 the amount of nutrients of infant formula and follow-on formula shall not be expressed as a percentage of the reference intakes se t out in Annex XIII 
to that Regulation. 
In addition to the form of expression referr ed to in paragraph 6, in the case of follow-
on formula, the declaration on vitamins and minerals in respect of the vitamins and 
minerals listed in Annex VII to this Regulation may be expressed as a percentage of the reference intakes set out in that Annex in relation to per 100 ml of the food ready 
for use after preparation in accordance with the manufacturer's instructions. 
8. The particulars included in the nutrition d eclaration for infant formula and follow-on 
formula that are not listed in Annex XV to Regulation (EU) No 1169/2011 shall be  
EN 13   EN 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 8 
Nutrition and health claims for infant formula 
Nutrition and health claims shall not be made on infant formula. 
Article 9 
Statements related to lactos e and docosahexaenoic acid (DHA) 
1. The statement 'lactose only' may be used for infant formula and follow-on formula 
provided that lactose is the only ca rbohydrate present in the product.  
2. The statement 'lactose free' may be used  for infant formula and follow-on formula 
provided that the lact ose content in the product is no t greater than 2,5 mg/100 kJ 
(10 mg/100 kcal).  
When the statement 'lactose free' is used for infant formula and follow-on formula 
manufactured from protein sources other than soya protein isolates, it shall be 
accompanied by the statement 'not suitable for infants with galactosaemia', which 
shall be indicated with the same font size and prominence as the statement 'lactose free' and in close proximity to it. 
3. The statement 'contains Docosahexaenoic acid (as required by the legislation for all 
infant formula)' or 'contai ns DHA (as required by the legislation for all infant 
formula)' may only be used for infant form ula placed on the market before [9 years 
after entry into force]. 
Article 10 
Requirements for promotional and commerc ial practices for infant formula 
1. Advertising of infant formula shall be re stricted to publications  specialising in baby 
care and scientific publications.  
Member States may further restrict or pr ohibit such advertising. Such advertising 
shall contain only information of a scientif ic and factual nature. Such information 
shall not imply or create a beli ef that bottle-feeding is equi valent or superior to breast 
feeding. 
2. There shall be no point-of-sale advert ising, giving of samples or any other 
promotional device to induce sales of infant formula directly to the consumer at the 
retail level, such as special  displays, discount coupons, pr emiums, special sales, loss-
leaders and tie-in sales. 
3. Manufacturers and distributors of infant formula shall not provide, to the general 
public or to pregnant women, mothers or members of their families, free or low-priced products, samples or a ny other promotional gifts, either directly or indirectly 
via the health care system or health workers. 
4. Donations or low-price sales of supplies of infant formula to institutions or 
organisations, whether for use in the institutions or for distribution outside them,  
EN 14   EN shall only be used by or distributed for in fants who have to be fed on infant formula 
and only for as long as required by such infants. 
Article 11 
Requirements on information relating to infant and young child feeding 
1. Member States shall take measures ensuring that objective and consistent 
information is provided on infant and young child feeding for use by families and those involved in the field of infant  and young child nutrition, and covering the 
planning, provision, design and dissemination of information and their control.  
2. Informational and educational materials, wh ether written or audiovisual, dealing with 
the feeding of infants and intended to reach  pregnant women and mothers of infants 
and young children, shall include clear information on all the following points: 
(a) the benefits and superi ority of breast feeding; 
(b) maternal nutrition and the preparation for and maintenance of breast feeding; 
(c) the possible negative effect on breas t feeding of introducing partial bottle 
feeding; 
(d) the difficulty of reversing th e decision not to breast feed; 
(e) where needed, the proper use of infant formula. Where such materials contain information about  the use of infant formula, they shall 
include the social and financial implicati ons of its use, the health hazards of 
inappropriate foods or feeding methods, a nd, in particular, the health hazards of 
improper use of infant formula. Such mate rial shall not use a ny pictures which may 
idealise the use of infant formula. 
3. Donations of informational or educationa l equipment or materials by manufacturers 
or distributors shall be made only on reque st and with the written approval of the 
appropriate national aut hority or within guidelines given by that authority for this 
purpose. Such equipment or materials may bear the donating company’s name or 
logo, but shall not refer to a proprietary brand of infant formula and shall be 
distributed only through th e health care system. 
Article 12 
Notification 
1. When infant formula is placed on the ma rket, the food business operator shall notify 
the competent authority of each Member St ate where the product concerned is being 
marketed of the information appearing on th e label, by sending to  it a model of the 
label used for the product, and of any othe r information the competent authority may 
reasonably request to establish compliance with this Regulation. 
2. When follow-on formula manufactured from protein hydrolysates or follow-on 
formula containing other substances than those listed in Annex II 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 aut hority may reasonably request to establish 
compliance with this Regulation, unless a Member State exempts the food business  
EN 15   EN operator from that obligation under a nati onal system that guarantees an efficient 
official monitoring of  the product concerned. 
Article 13 
Directive 2006/141/EC 
In accordance with Article 20(4) of Regulati on (EU) No 609/2013, Directive 2006/141/EC is 
repealed with effect from [ 4 years after entry into force, same date as the first date in the 
second paragraph of Article 14 ]. However, Directive 2006/141/EC shall continue to apply 
until [ 5 years after entry into force minus 1 day ] to infant formula and follow-on formula 
manufactured from protein hydrolysates. 
References to Directive 2006/141/EC in other acts shall be construed as references to this 
Regulation in accordance with the sche me set out in the first paragraph. 
Article 14 
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 [ 4 years after entry into force ], except in respect of infant formula and 
follow-on formula manufactured from protein hydr olysates, to which it shall apply from [ 5 
years after entry into force ].  
For the purposes of the sec ond subparagraph of Article 21( 1) of Regulation (EU) No 
609/2013, in respect of infant formula and fo llow-on formula manufact ured from protein 
hydrolysates the later date referred to in th e second paragraph of th is Article shall be 
considered as the date of application. 
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