EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10356/2015 
(POOL/E4/2015/10356/10356-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 informatio n requirements for food for 
special medical purposes 
(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repealed from the date of application of the delegated acts adopted by the Commission.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 
1999/21/EC on food for special medical purposes under the new framework of Regulation (EU) No 609/2013 and updates them  where relevant on the basis of the 
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 control
7, which met on the subject on 15 May, 
13 September and 15 November 2013, 7 February 2014 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 
Minor adjustments to the compositional requirements of  food for special medical 
purposes for infants are introdu ced to increase consistency with the rules applicable 
to infant formula and follow-on formula, in  line with the advice of the European 
Food Safety Authority9. 
With respect to labelling, changes compared to Directive 1999/21/EC are aimed at 
ensuring consistency with horizontal rule s 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
10, taking into account the spec ificities of the products. 
Rules are also adjusted to increase legal ce rtainty on the intended use of the products.  
Given that food for special medical purposes is to be used unde r medical supervision 
and should not be promoted di rectly to consumers, it is proposed to forbid the 
possibility to make nutrition and h ealth claims on this type of food. 
Upon request of the European  Parliament and the Council  in Regulation (EU) No 
609/2013, it is proposed to extend to food fo r special medical purposes for infants all 
rules on labelling, presentation, advertising and marketing applicable to formulae for 
healthy infants that would not be contrary  to the product's intended use. Also upon 
request of the Parliament a nd the Council, it is  proposed to extend to food for special 
medical purposes for infants and young childr en the same rules on pesticides that 
apply to infant formula, follow-on formul a, processed cereal-based food and baby 
food. 
The application of the Dele gated Regulation is deferr ed to allow food business 
operators to adapt to the technical changes. 
                                                 
9 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. 
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 compositional and information requirements for food for 
special medical purposes 
(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 1999/21/EC
12 lays down harmonised rules on dietary foods for 
special medical purposes in the framework of Directive 2009/39/EC of the European 
Parliament and of the Council13. 
(2) Directives 2009/39/EC and 1999/21/EC are repealed by Regulation (EU) 
No 609/2013. That Regulation lays down general compositional and information requirements for different categories of  food, including food for special medical 
purposes. The Commission has to adopt specific compositional and information requirements for food for special medical pur poses, taking into acc ount the provisions 
of Directive 1999/21/EC. 
(3) Food for special medical purposes is develope d in close cooperation with health care 
professionals to feed patients affected by  or malnourished beca use of a specific 
diagnosed disease, disorder or medical c ondition that makes it impossible or very 
difficult for those patients to satisfy thei r nutritional need s through the consumption of 
other foods
. For that reason, food for special me dical purposes must be used under 
medical supervision, which may be applied with the assistance of other competent health professionals. 
(4) The composition of food for special medical purposes may differ substantially 
depending, among others, on the specific diseas e, disorder or medical condition for the 
dietary management of which the product is  intended, on the age of the patients and 
                                                
 
11 OJ L 181, 29.6.2013, p. 35. 
12 Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes 
(OJ L 91, 7.4.1999, p. 29). 
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 the place in which they receive health care support, and the product's intended use. In 
particular, food for special medical purposes can be classified in  different categories 
depending on whether its composition is standa rd or specifically nut rient-adapted for a 
disease, disorder or medical condition a nd on whether or not it constitutes the sole 
source of nourishment for the pers ons for whom it is intended. 
(5) Because of the wide diversity of food for special medical purposes, the rapidly 
evolving scientific knowledge on which it is based, and the need to ensure adequate 
flexibility to develop innova tive products, it is not approp riate to lay down detailed 
compositional rules for such food products. It is however important to set principles 
and requirements specific to them in order to ensure that they are safe, beneficial and 
effective for the persons for whom they are intended on the basis of generally accepted 
scientific data.  
(6) In particular, the nutriti onal composition of food fo r special medical purposes 
developed to satisfy the nutritional requireme nts of infants should be based on that of 
infant formula and follow-on formula, in order to take into account the specificities of 
the nutritional require ments of infants. However, taki ng into account that infant 
formula and follow-on formula are intended fo r healthy infants, derogations should be 
provided for food for special medical purpos es developed to satisfy the nutritional 
requirements of infants when this is nece ssary for the intended use of the product. 
(7) It is important to set basic rules con cerning the content of vitamin and mineral 
substances in food for special medical purposes  in order to ensure the free circulation 
of products which are different in compositi on and the protection of consumers. Such 
rules should be based on t hose of Directive 1999/21/EC, gi ven that they have ensured 
an adequate framework for food for special  medical purposes so far. Rules should 
include minimum and maximum amounts, in the case of products considered to be 
nutritionally complete for covering the nutritional requirements of the patient, and 
maximum amounts only, in the case of pr oducts considered to  be nutritionally 
incomplete, without prejudice to modificatio ns for one or more of these nutrients 
rendered necessary by the inte nded use of the product.  
(8) Pursuant to Regulation (EU) No 609/2013, th e Commission has to adopt provisions 
restricting or prohibiting the use of pestic ides and on pesticide residues in food for 
special medical purposes developed to satisfy  the nutritional requ irements of infants 
and young children. Adopting provisions that ar e in line with the current scientific 
knowledge requires a significant amount of  time, given that a comprehensive 
evaluation has to be carried out by the Eu ropean Food Safety Authority on a number 
of aspects, including the a ppropriateness of the toxicol ogical reference values for 
infants and young children.  
EN 6   EN (9) Directive 1999/21/EC does not lay down su ch provisions. Commission Directives 
2006/125/EC14 and 2006/141/EC15, however, do currently lay down specific 
requirements in this respect for foods fo r healthy infants and young children, based on 
two opinions given by the Scientific Committee for Food (SCF) on 19 September 
199716 and 4 June 199817.  
(10) 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 exis ting requirements of 
Directives 2006/125/EC and 2006/141/EC shoul d, at this stage, be taken over. 
However, it is appropriate to use the te rminology of Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council18. 
(11) 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 in take conditions, le ad to an exposure 
exceeding the acceptable daily intake (ADI) for infants and young children.  
(12) A prohibition of the use of cer tain pesticides would not n ecessarily guara ntee that food 
for special medical purposes developed to satisfy the nutritional requirements of 
infants and young children is free from those pesticides, since some pesticides are 
persistent in the environment and their re sidues can be found in the food. For that 
reason, those pesticides, are c onsidered not to have been used if residues are below a 
certain level.  
(13) Food for special medical purposes has to comply with Regulation (EU) No 1169/2011 
of the European Parlia ment and of the Council19. In order to take account of the 
specific nature of food for special medical  purposes, this Regula tion should lay down 
additions and exceptions to those general rules, where appropriate. 
(14) Providing all information that is necessary to ensure the appropr iate use of food for 
special medical purposes should be mandatory for this type of food. That information 
should include information on the properties and characteristics in relation to, among 
others, the special processing and formulati on, nutritional compositi on and rationale of 
use of the product that make it useful for its specific inte nded purpose. Such 
information should not be considered as nutrition and health claims within the 
                                                 
14 Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and 
young children (OJ L 339, 6.12.2006, p. 16). 
15 Commission Directive 2006/141/EC of 22 December 2006 on infant formula and follow-on formula 
and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, 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). 
18 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).  
19 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 meaning of Regulation (EC) No 1924/2006 of the European Parliament and of the 
Council20.  
(15) The nutrition declaration for f ood for special medical purposes is essential in order to 
guarantee its appropriate use, both for patient s consuming that food and for health care 
professionals who recommend its consumption. For that reason and in order to provide 
more complete information to patients and healthcare professionals, the nutrition 
declaration should include more particular s than those required by Regulation (EU) 
No 1169/2011. In addition, the exemption prov ided for in point 18 of Annex V to 
Regulation (EU) No 1169/2011 s hould not apply and the nut rition declaration should 
be mandatory for all food for special medi cal purposes, irrespective of the package or 
container size.  
(16) Consumers of food for special medical purposes have differe nt nutritional needs than 
the normal population. The expression of nut rition information on the energy value 
and the amount of nutrients of food for sp ecial medical purposes as a percentage of 
daily reference intake valu es set out in Regulation (E U) No 1169/2011 would mislead 
consumers and should therefore not be allowed. 
(17) The use of nutrition and health clai ms authorised under Regulation (EC) 
No 1924/2006 to promote food for special medi cal purposes would not be appropriate, 
since consumers of such products are patien ts suffering from a dise ase, disorder or 
condition and are, therefore, not part of the general healthy population. In addition, food for special medical purposes is to be used under medical supervision and its 
consumption should not be promoted through the use of nutrition and health claims directly targeting consumers. For those reas ons, the use of nutrition and health claims 
should not be allowed for food for special medical purposes.  
(18) In the past years, an increasing number of products have been placed on the market as 
food for special medical purposes developed to  satisfy the nutritional requirements of 
infants. These products are sometimes promoted with means directly targeting 
consumers that are not subject to the restrictions under Unio n legislation applicable to 
infant formula and follow-on formula. In or der to avoid possible abuses linked to the 
misclassification of products, reduce confus ion for consumers on the nature of the 
different products being offered to them a nd guarantee conditions of fair competition, 
it seems appropriate to introduce additional re strictions on the labelling, presentation, 
advertising, and promotional and commerci al practices of food for special medical 
purposes developed to satisfy the nutritional requirements of infants. Those restrictions should be similar to those a pplicable to infant formula and follow-on 
formula for healthy infants, with adjustme nts taking into account the intended use of 
the product and without prejudice to the need  to provide food information to patients 
and health care professionals to ensure the product’s appropriate use. Given that food 
for special medical purposes is to be used under medical supervision, those restrictions 
should not make it more difficult for food business operators to  communicate with 
health care professionals and should allo w health care professionals to assess the 
suitability of different produc ts for their intended use.  
                                                
 
20 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 (19) 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 official monitoring of food for special medical purposes, food 
business operators placing food for special  medical purposes on the market should 
provide the national competen t authorities with a model of the label used and all 
relevant information considered necessary  to demonstrate compliance with this 
Regulation, unless Member States have a different efficient monitoring system.  
(20) In order to enable food business operators to adapt to the new requirements, this 
Regulation should apply from a date that is  three years after its  entry into force. 
Taking into account the number and importan ce of the new requirements applicable to 
food for special medical purposes developed to  satisfy the nutritional requirements of 
infants, in respect of such products this Regulation should apply from a date that is 
four years after its entry into force,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Placing on the market 
Food for special medical purposes may only be pl aced on the market if it complies with this 
Regulation. 
Article 2 
Compositional requirements 
1. Food for special medical purpos es is classified in the following three categories: 
(a) nutritionally complete f ood with a standard nutrient formulation which, used in 
accordance with the manufacturer's instruct ions, may constitute the sole source 
of nourishment for the persons for whom it is intended; 
(b) nutritionally complete food with a nutri ent-adapted formulation specific for a 
disease, disorder or medical condition which, used in accordance with the 
manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended; 
(c) nutritionally incomplete food with a st andard formulation or  a nutrient-adapted 
formulation specific for a disease, disord er or medical condition which is not 
suitable to be used as the sole source of nourishment. 
The food referred to in points (a) and (b) of the first subparagraph may also be used 
as a partial replacement or as a supplement to the patient's diet. 
2. The formulation of food for special me dical purposes shall be based on sound 
medical and nutritional principles. Its use,  in accordance with the manufacturer's 
instructions, shall be safe, beneficial and effective in meeting the specific nutritional 
requirements of the persons for whom it is  intended, as demonstrated by generally 
accepted scientific data. 
                                                
 
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 9   EN 3. Food for special medical purposes develope d to satisfy the nutritional requirements 
of infants shall comply with the compositional requirements set out in Part A of Annex I. 
Food for special medical purposes other than that developed to sa tisfy the nutritional 
requirements of infants shall comply with  the compositional requirements set out in 
Part B of Annex I. 
4. The compositional requirements set out in A nnex I shall apply to the food for special 
medical purposes ready for use, marketed as  such or after preparation in accordance 
with the manufacturer's instructions.   
Article 3 
Requirements on pesticides in food for special  medical purposes deve loped to satisfy the 
nutritional requireme nts of infants and young children 
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. Food for special medical purposes develope d to satisfy the nutritional requirements 
of infants and young children shall not co ntain 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 II, 
the maximum residue levels specif ied in that Annex shall apply. 
4. Food for special medical purposes develope d to satisfy the nutritional requirements 
of infants and young children shall only be produced from agri cultural products for 
the production of which plant protection pr oducts containing the active substances 
listed in Annex III have not been used. 
However, for the purpose of checks, plant protection products co ntaining the active 
substances listed in Annex III 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 food for special 
medical purposes ready for use, marketed as  such or after preparation in accordance 
with the manufacturer's instructions.  
Article 4 
Name of the food 
The name of food for special medical purpos es shall be as se t out in Annex IV. 
Article 5 
Specific requirements on food information 
1. Unless otherwise provided in this Regulati on, food for special medical purposes shall 
comply with Regulation (EU) No 1169/2011.   
EN 10   EN 2. In addition to the mandatory particulars listed in Article 9(1) of Regulation (EU) 
No 1169/2011, the following shall be additiona l mandatory particulars for food for 
special medical purposes: 
(a) a statement that the product must  be used under medical supervision; 
(b) a statement whether the product is su itable for use as the sole source of 
nourishment; 
(c) a statement that the product is intended  for a specific age group, as appropriate; 
(d) where appropriate, a statement that the product poses a h ealth hazard when 
consumed by persons who do not have the disease, disorder or medical 
condition for which the product is intended; 
(e) the statement ‘For the dietary manageme nt of…’ where the blank shall be filled 
in with the disease, disorder or medi cal condition for wh ich the product is 
intended; 
(f) where appropriate, a statement concer ning adequate precautions and contra-
indications; 
(g) a description of the properties and/or  characteristics that make the product 
useful in relation to the disease, disord er or medical condition for the dietary 
management of which the product is intended, in particular, as the case may be, relating to the special processing and formulation, the nutrients which have 
been increased, reduced, eliminated or ot herwise modified and the rationale of 
the use of the product;  
(h) where appropriate, a warning that the product is not for parenteral use; 
(i) instructions for appropriate preparati on, use and storage of the product after the 
opening of the container, as appropriate. 
The particulars referred to in points (a ) to (d) shall be preceded by the words 
‘important notice’ or  their equivalent. 
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 6  
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 food for special medical purposes shall include the following: 
(a) the amount of each mineral substance a nd of each vitamin listed in Annex I to 
this Regulation and present in the product; 
(b) the amount of components of prot ein, carbohydrate, fat and/or of other 
nutrients and their components, the decl aration of which would be necessary 
for the appropriate intended use of the product; 
(c) information on the osmolality or the osmolarity of the product where 
appropriate; 
(d) information on the source and the na ture of the protei n and/or protein 
hydrolysates contained in the product.  
EN 11   EN 2. By way of derogation from Article 30( 3) of Regulation (EU) No 1169/2011, the 
information included in the mandatory nutr ition declaration for food for special 
medical purposes shall not be repeated on the labelling.  
3. The nutrition declaration shall be mandatory for a ll food for special medical 
purposes, irrespective of the size of the larges t surface of the packaging or container.  
4. Articles 31 to 35 of Regulation (EU) No 1169/2011 shall apply to all the nutrients 
included in the nutrition declaration fo r food for special medical purposes.  
5. By way of derogation from Article 31( 3) of Regulation (EU) No 1169/2011, the 
energy value and the amounts of nutrients of  food for special medical purposes shall 
be those of the food as  sold and, where appropriate, those of the food ready for use 
after preparation in accordance with the manufacturer's instructions. 
6. 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 food for speci al medical purposes 
shall not be expressed as a percentage of the reference intakes se t out in Annex XIII 
to that Regulation. 
7. The particulars included in the nutrition declaration for food for special medical 
purposes that are not listed in Annex XV  to Regulation (EU) No 1169/2011 shall be 
presented after the most relevant entry of that Annex they belong to or are 
components of.  
Particulars not listed in Annex XV to  Regulation (EU) No 1169/2011 that do not 
belong to or are not compone nts of any of the entries of that Annex shall be 
presented in the nutrition declaration after the last entry of that Annex. 
The indication of the amount of sodium shall appear together with  the other minerals 
and may be repeated next to the indication of the salt content as follows: “Salt : X g 
(of which sodium: Y mg)” . 
Article 7 
Nutrition and health claims 
Nutrition and health claims shall not be  made on food for special medical purposes. 
Article 8 
Specific requirements for food for special medical purposes developed to satisfy the 
nutritional requireme nts of infants 
1. All mandatory particulars for food for spec ial medical purposes de veloped to satisfy 
the nutritional requirements of infants shal l appear in a language easily understood 
by the consumers.  
2. The labelling, presentation and advertis ing of food for special medical purposes 
developed to satisfy the nutritional requireme nts of infants shall not include pictures 
of infants, or other pictur es or text which may idealise the use of the product.  
However, graphic representations for eas y identification of the product and for 
illustrating methods of preparation shall be permitted. 
3. The labelling, presentation and advertis ing of food for special medical purposes 
developed to satisfy the nutritional requireme nts of infants shall be designed in such 
a way that it enables consumers to make a clear distinction be tween such products  
EN 12   EN and infant formula and follow-on formula, in  particular as to the text, images and 
colours used, so as to av oid any risk of confusion. 
4. Advertising of food for speci al medical purposes develope d to satisfy the nutritional 
requirements of infants shall be restricted to publicati ons 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 scientific and factual nature. 
The first and second subparagraphs sh all not prevent the dissemination of 
information exclusively intended for health care professionals. 
5. There shall be no point-of-sale advert ising, giving of samples or any other 
promotional device to induce sales of food for special me dical purposes developed to 
satisfy the nutritional requirements of infant s directly to the consumer at the retail 
level, such as special displays, discount  coupons, premiums, special sales, loss-
leaders and tie-in sales. 
6. Manufacturers and distributors of food fo r special medical purposes developed to 
satisfy the nutritional requirements of infant s shall not directly 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.  
Article 9 
Notification 
When food for special medical purposes is pl aced 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 th e label, by sending to it  a model of the label 
used for the product, and of any other inform ation the competent authority may reasonably 
request to establish compliance with this Regulation, unless a Me mber State exempts the food 
business operator from that obligation under a national system that guarantees an efficient 
official monitoring of  the product concerned. 
Article 10 
Directive 1999/21/EC 
In accordance with Article 20(4) of Regulat ion (EU) No 609/2013, Directive 1999/21/EC is 
repealed with effect from [ 3 years after entry into force, same date as the first date in the 
second paragraph of Article 11 ]. However, Directive 1999/21/EC shall continue to apply until 
[4 years after entry into force minus 1 day ] to food for special medical purposes developed to 
satisfy the nutritional re quirements of infants.  
References to Directive 1999/21/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 11 
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 .  
EN 13   EN It shall apply from [ 3 years after entry into force ], except in respec t of food for special 
medical purposes developed to satis fy the nutritional requirements of infants, to which it shall 
apply from [ 4 years after entry into force ]. 
For the purposes of the second subparagra ph of Article 21(1) of Regulation (EU) 
No 609/2013, in respect of food for special me dical purposes developed to satisfy the 
nutritional requirements of infants the later date  referred to in the second paragraph of this 
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