5394/1/13 REV 1  DPA/NC/vm  
 DG B 4  EMglyphffvm     
COUMglyphffvmCIL OF  
THE EUROPEAMglyphffvm UMglyphffvmIOMglyphffvm   Brussels, 23 April 2013 
(OR. en) 
Interinstitutional File: 
2011/0156 (COD)  5394/1/13 
REV 1 
 
  
 
  DEMglyphffvmLEG 4 
AGRI 20 
SAMglyphffvm 17 
CODEC 94 
PARLMglyphffvmAT 98 
LEGISLATIVE ACTS AMglyphffvmD OTHER IMglyphffvmSTRUMEMglyphffvmTS 
Subject: Position of the Council at first reading with a view to the adoption of a 
Regulation of the European Parliament and of the Council 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, Commission Directives 96/8/EC, 
1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of 
the European Parliament and of the Council and Commission 
Regulations (EC) No 41/2009 and (EC) No 953/2009 
- Adopted by the Council on 22 April 2013 
  
 
 
 
5394/1/13 REV 1  DPA/NC/vm 1 
 DG B 4  EMglyphffvm  REGULATIOMglyphffvm (EU) Mglyphffvmo …/2013 
OF THE EUROPEAMglyphffvm PARLIAMEMglyphffvmT AMglyphffvmD OF THE COUMglyphffvmCIL 
of… 
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, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, 
Directive 2009/39/EC of the European Parliament and of the Council 
and Commission Regulations (EC) Mglyphffvmo 41/2009 and (EC) Mglyphffvmo 953/2009  
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNIO N, 
Having regard to the Treaty on the Functioning of the European Union, and in partic ular Article 114  
thereof,  
 
5394/1/13 REV 1  DPA/NC/vm 2 
 DG B 4  EMglyphffvm  Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national parliament s, 
Having regard to the opinion of the European Economic and Social Committee 1, 
Acting in accordance with the ordinary legislative procedure 2, 
                                                 
1 OJ C 24, 28.1.2012, p. 119. 
2 Position of the European Parliament of 14 June 2012 (not yet published in the 
Official Journal) and position of the Council at first reading of … [(OJ …)] [(not yet 
published in the Official Journal)]. Position of the European Parliament of [ (OJ …)] [(not 
yet published in the Official Journal)] [and decision of the Council of …].   
 
5394/1/13 REV 1  DPA/NC/vm 3 
 DG B 4  EMglyphffvm  Whereas: 
(1) Article 114 of the Treaty on the Functioning of the European Union (TFEU) provi des that, 
for measures having as their object the establishment and functioning of the internal 
market, and which concern, inter alia, health, safety and consumer protection, 
the Commission is to take as a base a high level of protection taking account  in particular 
of any new development based on scientific facts.   
(2) The free movement of safe and wholesome food is an essential aspect of the inte rnal 
market and contributes significantly to the health and well-being of citizens , and to their 
social and economic interests.  
(3) Union law applicable to food is intended, inter alia, to ensure that no food is placed on t he 
market if it is unsafe. Therefore, any substances that are considered to be injurious to the 
health of the population groups concerned or unfit for human consumption should be 
excluded from the composition of the categories of food covered by this Regulation. 
(4) Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on 
foodstuffs intended for particular nutritional uses 1 lays down general rules on the 
composition and preparation of foods that are specially designed to meet the pa rticular 
nutritional requirements of the persons for whom they are intended. The majori ty of the 
provisions laid down in that Directive date back to 1977 and need to be reviewed.  
                                                 
1 OJ L 124, 20.5.2009, p. 21.  
 
5394/1/13 REV 1  DPA/NC/vm 4 
 DG B 4  EMglyphffvm  (5) Directive 2009/39/EC establishes a common definition for 'foodstuffs for par ticular 
nutritional uses', and general labelling requirements, including that such foods  should bear 
an indication of their suitability for the nutritional purposes being claim ed. 
(6) The general compositional and labelling requirements laid down in Directive  2009/39/EC 
are complemented by a number of non-legislative Union acts, which are appli cable to 
specific categories of food. In that respect, harmonised rules are lai d down in Commission 
Directives 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted 
diets for weight reduction 1 and 1999/21/EC of 25 March 1999 on dietary foods for special 
medical purposes 2. Similarly, Commission Directive 2006/125/EC 3 lays down certain 
harmonised rules with respect to processed cereal-based foods and baby fo ods for infants 
and young children. Commission Directive 2006/141/EC 4 lays down harmonised rules 
with respect to infant formulae and follow-on formulae and Commission Regulati on (EC) 
No 41/2009 5 lays down harmonised rules concerning the composition and labelling of 
foodstuffs suitable for people intolerant to gluten. 
                                                 
1 OJ L 55, 6.3.1996, p. 22. 
2 OJ L 91,7.4.1999, p. 29.  
3 OJ L 339, 6.12.2006, p. 16. 
4 OJ L 401, 30.12.2006. p. 1.  
5 OJ L 16, 21.1.2009, p. 3.  
 
5394/1/13 REV 1  DPA/NC/vm 5 
 DG B 4  EMglyphffvm  (7) In addition, harmonised rules are laid down in Council Directive 92/52/EEC 
of 18 June 1992 on infant formulae and follow-on formulae intended for export to third 
countries 1 and in Commission Regulation (EC) No 953/2009 of 13 October 2009 on 
substances that may be added for specific nutritional purposes in foods for particular 
nutritional uses 2.  
(8) Directive 2009/39/EC requires a general notification procedure at nationa l level for food 
presented by food business operators as coming within the definition of 'foodst uffs for 
particular nutritional uses' for which no specific provisions have been laid d own in Union 
law, prior to its being placed on the Union market, in order to facilitate the  efficient 
monitoring of such food by the Member States. 
(9) A report from the Commission of 27 June 2008 to the European Parliament and to 
the Council on the implementation of that notification procedure showed that diffic ulties 
can arise from the definition of 'foodstuffs for particular nutritional uses' w hich appeared to 
be open to differing interpretations by the national authorities. It there fore concluded that a 
revision of Directive 2009/39/EC would be required to ensure a more effective and 
harmonised implementation of Union legal acts. 
                                                 
1 OJ L 179, 1.7.1992, p. 129. 
2 OJ L 269, 14.10.2009, p. 9.  
 
5394/1/13 REV 1  DPA/NC/vm 6 
 DG B 4  EMglyphffvm  (10) A study report of 29 April 2009 by Agra CEAS Consulting, concerning the revision of  
Directive 2009/39/EC, confirmed the findings of the Commission report of 27 June 2008 
on the implementation of the notification procedure and indicated that an increasi ng 
number of foodstuffs are currently marketed and labelled as foodstuffs suitab le for 
particular nutritional uses, due to the broad definition laid down in that Directive. The  
study report also pointed out that food regulated under that Directive differs  significantly 
between Member States; similar food could at the same time be marke ted in different 
Member States as food for particular nutritional uses and/or as food for normal  
consumption, including food supplements, addressed to the population in general or to 
certain subgroups thereof such as pregnant women, postmenopausal women , older adults, 
growing children, adolescents, variably active individuals and others. This sta te of affairs 
undermines the functioning of the internal market, creates legal uncertainty for competent 
authorities, food business operators, in particular small and medium-sized e nterprises 
(SMEs), and consumers, while the risks of marketing abuse and distortion of competit ion 
cannot be ruled out.  There is therefore a need to eliminate differences in interpretation by 
simplifying the regulatory environment.  
 
5394/1/13 REV 1  DPA/NC/vm 7 
 DG B 4  EMglyphffvm  (11) It appears that other, recently adopted, Union legal acts are more adapte d to an evolving 
and innovative food market than Directive 2009/39/EC. Of particular relevance and 
importance in that respect are: Directive 2002/46/EC of the European Parliam ent and the 
Council of 10 June 2002 on the approximation of the laws of the Member States relating to 
food supplements 1, Regulation (EC) No 1924/2006 of the European Parliament and the 
Council of 20 December 2006 on nutrition and health claims made on foods 2 and 
Regulation (EC) No 1925/2006 of the European Parliament and the Council 
of 20 December 2006 on the addition of vitamins and minerals and of certain other 
substances to foods 3. Furthermore, the provisions of those Union legal acts would 
adequately regulate a number of the categories of food covered by Directive  2009/39/EC 
with less of an administrative burden and more clarity as to scope and object ives. 
(12) Moreover, experience shows that certain rules included in, or adopted under, 
Directive 2009/39/EC are no longer effective in ensuring the functioning of the 
internal market. 
(13) Therefore, the concept of 'foodstuffs for particular nutritional uses'  should be abolished and 
Directive 2009/39/EC should be replaced by this act. To simplify the applica tion of this act 
and to ensure consistency of application throughout the Member States, this a ct should take 
the form of a Regulation. 
                                                 
1 OJ L 183, 12.7.2002, p. 51. 
2 OJ L 404, 30.12.2006, p. 9. 
3 OJ L 404, 30.12.2006, p. 26.  
 
5394/1/13 REV 1  DPA/NC/vm 8 
 DG B 4  EMglyphffvm  (14) 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 i n matters of 
food safety 1 establishes common principles and definitions for Union food law. Certain 
definitions laid down in that Regulation should also apply in the context of this Regulati on.  
(15) A limited number of categories of food constitute a partial or the sole s ource of 
nourishment for certain population groups. Such categories of food are vital for t he 
management of certain conditions and/or are essential to satisfy the nutriti onal 
requirements of certain clearly identified vulnerable population groups . Those categories 
of food include infant formula and follow-on formula, processed cereal-based food and 
baby food, and food for special medical purposes. Experience has shown that t he 
provisions laid down in Directives 1999/21/EC, 2006/125/EC and 2006/141/EC ensure the 
free movement of those categories of food in a satisfactory manner, while ens uring a high 
level of protection of public health. It is therefore appropriate t hat this Regulation focuses 
on the general compositional and information requirements for those categories of food, 
taking into account Directives 1999/21/EC, 2006/125/EC and 2006/141/EC.  
                                                 
1 OJ L 31, 1.2.2002, p. 1.  
 
5394/1/13 REV 1  DPA/NC/vm 9 
 DG B 4  EMglyphffvm  (16) In addition, in view of the growing rates of people with problems relat ed to being 
overweight or obese, an increasing number of foods are placed on the market as tot al diet 
replacement for weight control. Currently, for such foods  present in the market a 
distinction can be made between products intended for low calorie diets, whi ch contain 
between 3 360 kJ (800 kcal) and 5 040 kJ (1 200 kcal), and products intended for very low 
calorie diets,  which normally contain fewer than 3 360 kJ (800 kcal). Given the nature of 
the foods in question it is appropriate to lay down certain specific provision s for them. 
Experience has shown that the relevant provisions laid down in Directive 96/8/EC  ensure 
the free movement of foods presented as total diet replacement for weight c ontrol in a 
satisfactory manner while ensuring a high level of protection of public  health. It is 
therefore appropriate that this Regulation focuses on the general compositiona l and 
information requirements for foods intended to replace the whole of the daily diet 
including foods of which the energy content is very low, taking into account the rele vant 
provisions of Directive 96/8/EC.  
(17) This Regulation should establish, inter alia, definitions of infant formula and follow -on 
formula, processed cereal-based food and baby food, food for special medical p urposes, 
and total diet replacement for weight control, taking into account relevant provi sions in 
Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC.  
 
5394/1/13 REV 1  DPA/NC/vm 10 
 DG B 4  EMglyphffvm  (18) Regulation (EC) No 178/2002 establishes the principles of risk analysis  in relation to food 
and establishes the structures and mechanisms for the scientific and technica l evaluations 
which are undertaken by the European Food Safety Authority ('the Authority '). For the 
purpose of this Regulation, the Authority should be consulted on all matters likely to a ffect 
public health. 
(19) It is important that ingredients used in the manufacture of food covered by this R egulation 
are appropriate for satisfying the nutritional requirements of, and are s uitable for, the 
persons for whom such food is intended and that their nutritional adequacy has been 
established by generally accepted scientific data. Such adequacy shoul d be demonstrated 
through a systematic review of the available scientific data. 
(20) Maximum residue levels of pesticides set out in relevant Union law, in par ticular 
Regulation (EC) No 396/2005 of the European Parliament and of the Council 
of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of 
plant and animal origin 1, should apply without prejudice to specific provisions set out in 
this Regulation and delegated acts adopted pursuant to this Regulation. 
                                                 
1 OJ L 70, 16.3.2005, p. 1.   
 
5394/1/13 REV 1  DPA/NC/vm 11 
 DG B 4  EMglyphffvm  (21) The use of pesticides can lead to pesticide residues in food that is covered b y this 
Regulation. Such use should, therefore, be restricted as much as possible, taking  into 
account the requirements of Regulation (EC) No 1107/2009 of the European Parliament 
and of the Council of 21 October 2009 concerning the placing of plant protection produc ts 
on the market 1. However, a restriction on, or a prohibition of, use would not necessarily 
guarantee that food covered by this Regulation, including food for infants and young 
children, is free from pesticides, since some pesticides contaminate the  environment and 
their residues can be found in such food. Therefore, the maximum residue levels in such 
food should be set at the lowest achievable level to protect vulnerable popul ation groups, 
taking into account good agricultural practices as well as other sources of  exposure, such 
as environmental contamination.  
(22) Restrictions on and prohibitions of certain pesticides equivalent to those  currently 
established in the Annexes to Directives 2006/125/EC and 2006/141/EC should be taken 
into account in delegated acts adopted pursuant to this Regulation. Those restri ctions and 
prohibitions should be updated regularly, with particular attention to be p aid to pesticides 
containing active substances, safeners or synergists classified in a ccordance with 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council 
of 16 December 2008 on classification, labelling and packaging of substance s and 
mixtures 2 as mutagen category 1A or 1B, carcinogen category 1A or 1B, toxic for 
reproduction category 1A or 1B, or considered to have endocrine-disrupting prop erties that 
can cause adverse effects in humans. 
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 OJ L 353, 31.12.2008, p. 1.  
 
5394/1/13 REV 1  DPA/NC/vm 12 
 DG B 4  EMglyphffvm  (23) Substances falling within the scope of Regulation (EC) No 258/97 of the 
European Parliament and of the Council of 27 January 1997 concerning novel foods and 
novel food ingredients 1 should not be added to food covered by this Regulation unless such 
substances fulfil the conditions for being placed on the market under  Regulation (EC) 
No 258/97 in addition to the conditions set out in this Regulation and delegated acts 
adopted pursuant to this Regulation. When there is a significant change in the produc tion 
method of a substance that has been used in accordance with this Regulation or a chan ge in 
particle size of such a substance, for example through nanotechnology, that sub stance 
should be considered different from the one that has been used in accordance wit h this 
Regulation and should be re-evaluated under Regulation (EC) No 258/97 and subsequentl y 
under this Regulation.  
(24) 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 2 lays down general 
labelling requirements. Those labelling requirements should, as a general rule , apply to the 
categories of food covered by this Regulation. However, this Regulation should al so 
provide for additional requirements to, or derogations from, Regulation (EU) 
No 1169/2011, where necessary, in order to meet the specific objectives of this Re gulation.  
                                                 
1 OJ L 43, 14.2.1997, p. 1. 
2 OJ L 304, 22.11.2011, p. 18.  
 
5394/1/13 REV 1  DPA/NC/vm 13 
 DG B 4  EMglyphffvm  (25) The labelling, presentation or advertising of food covered by this Regula tion should not 
attribute to such food the property of preventing, treating or curing a huma n disease nor 
should they imply such properties. Food for special medical purposes, howeve r, is intended 
for the dietary management of patients with a limited, impaired or disturbe d capacity, for 
example, to take ordinary food because of a specific disease, disorder or medic al condition. 
Reference to the dietary management of diseases, disorders or medical con ditions for 
which the food is intended should not be considered as attribution of the property of the 
preventing, treating or curing a human disease.   
(26) In the interest of protecting vulnerable consumers, labelling requireme nts should ensure 
accurate product identification for consumers. In the case of infant formula  and follow-on 
formula, all written and pictorial information should enable a clear distinct ion to be made 
between different formulae. Difficulty in identifying the precise age  of an infant pictured 
on labelling could confuse consumers and impede product identification. That risk should 
be avoided by appropriate restrictions on labelling. Furthermore, taking i nto account that 
infant formula constitutes food that satisfies by itself the nutritional requi rements of infants 
from birth until introduction of appropriate complementary feeding, prop er product 
identification is crucial for the protection of consumers. Appropriate res trictions should, 
therefore, be introduced concerning the presentation and advertising of infant  formula.   
 
5394/1/13 REV 1  DPA/NC/vm 14 
 DG B 4  EMglyphffvm  (27) This Regulation should provide the criteria for the establishment of the sp ecific 
compositional and information requirements for infant formula, follow-on formula, 
processed cereal-based food and baby food, food for special medical purpose s, and total 
diet replacement for weight control, taking into account Directives 96/8/EC, 1999/21/E C, 
2006/125/EC and 2006/141/EC.  
(28) Regulation (EC) No 1924/2006 establishes the rules and conditions for the use of nutri tion 
and health claims on food. Those rules should apply as a general rule to the categori es of 
food covered by this Regulation, unless otherwise specified in this Regulation or del egated 
acts adopted pursuant to this Regulation.  
(29) According to the recommendations of the World Health Organisation, low birth w eight 
infants should be fed mother's milk. Nonetheless, low birth weight infants and pr e-term 
infants may have special nutritional requirements which cannot be met by  mother's milk or 
standard infant formula. In fact, the nutritional requirements of a low birth w eight infant 
and a pre-term infant can depend on the medical condition of that infant, in particula r on 
that infant’s weight in comparison with that of an infant in good health, and on the number 
of weeks the infant is premature. It is to be decided on a case-by-case basis whether the 
infant's condition requires the consumption,  under medical supervision,  of a food for 
special medical purposes developed to satisfy the nutritional requirem ents of infants 
(formula) and adapted for the dietary management of that infant's specifi c condition.  
 
5394/1/13 REV 1  DPA/NC/vm 15 
 DG B 4  EMglyphffvm  (30) Directive 1999/21/EC requires that certain compositional requirements for  infant formula 
and for follow-on formula as set out in Directive 2006/141/EC apply to food for special 
medical purposes intended for infants, depending on their age. However, certain 
provisions, including those relating to labelling, presentation, advertising, and promotional 
and commercial practices, set out in Directive 2006/141/EC currently do not apply  to such 
food. Developments in the market accompanied by a significant increase of  such food 
make it necessary to review requirements for formulae intended for infants such a s 
requirements on the use of pesticides in products intended for production of such for mulae, 
pesticide residues, labelling, presentation, advertising, and promotional a nd commercial 
practices that should also apply, as appropriate, to food for special medic al purposes 
developed to satisfy the nutritional requirements of infants.    
 
5394/1/13 REV 1  DPA/NC/vm 16 
 DG B 4  EMglyphffvm  (31) There is an increasing number of milk-based drinks and similar products on t he Union 
market which are promoted as being particularly suitable for young c hildren. Such 
products, which can be derived from protein of animal or vegetable origin such as  cows' 
milk, goats' milk, soy or rice, are often marketed as 'growing up milks' or 'toddlers' milks' 
or with similar terminology. While these products are currently regulat ed by different legal 
acts of the Union, such as Regulations (EC) No 178/2002, (EC) No 1924/2006 and (EC) 
No 1925/2006, and Directive 2009/39/EC, they are not covered by the existing specific 
measures applying to food intended for infants and young children. Different view s exist as 
to whether such products satisfy the specific nutritional requirements of the  population 
group they target. The Commission should therefore, after consulting the Authori ty, 
present to the European Parliament and to the Council a report on the necessity, i f any, of 
special provisions regarding the composition, labelling and other types of r equirements, if 
appropriate, of those products. This report should consider, inter alia, the nutr itional 
requirements of young children and the role of those products in their diet, taking i nto 
account the pattern of consumption, the nutritional intake and the levels of exposure  of 
young children to contaminants and pesticides. The report should also consider the 
composition of such products and whether they have any nutritional benefits when 
compared to a normal diet for a child who is being weaned. The Commission could  
accompany this report with a legislative proposal.  
 
5394/1/13 REV 1  DPA/NC/vm 17 
 DG B 4  EMglyphffvm  (32) Directive 2009/39/EC provides that specific provisions can be adopted r egarding the 
following two specific categories of food falling within the definition of foodstuf fs for 
particular nutritional uses: 'food intended to meet the expenditure of intense muscul ar 
effort, especially for sportsmen' and 'food for persons suffering from ca rbohydrate 
metabolism disorders (diabetes)'. As regards special provisions for f ood for persons 
suffering from carbohydrate metabolism disorders (diabetes),  a Commission report to the 
European Parliament and to the Council of 26 June 2008 on foods for persons suffering 
from carbohydrate metabolism disorders (diabetes) concluded that the scie ntific basis for 
setting specific compositional requirements is lacking. With regard to food int ended to 
meet the expenditure of intense muscular effort, especially for sportsm en, no successful 
conclusion could be reached as regards the development of specific provisions due t o 
widely diverging views among the Member States and stakeholders concerning the s cope 
of specific legislation, the number of subcategories of food to be included, the  criteria for 
establishing compositional requirements and the potential impact on innovation in product 
development. Therefore, specific provisions should not be developed at this st age. 
Meanwhile, on the basis of requests submitted by food business operators , relevant claims 
have been considered for authorisation in accordance with Regulation (EC) No 1924/2006 .  
 
5394/1/13 REV 1  DPA/NC/vm 18 
 DG B 4  EMglyphffvm  (33) However, different views exist as to whether additional rules are needed t o ensure an 
adequate protection of consumers of food intended for sportsmen, also called food 
intended to meet the expenditure of intense muscular effort. The Commission should, 
therefore, be invited, after consulting the Authority, to submit to the European  Parliament 
and to the Council a report on the necessity, if any, of provisions concerning food intended 
for sportsmen. The consultation of the Authority should take into account the report 
of 28 February 2001 of the Scientific Committee on Food on composition and specification 
of food intended to meet the expenditure of intense muscular effort, especially fo r 
sportsmen. In its report, the Commission should, in particular, evaluate whet her provisions 
are necessary to ensure the protection of consumers.  
(34) The Commission should be able to adopt technical guidelines aimed at facilit ating 
compliance by food business operators, in particular SMEs, with this Re gulation. 
(35) Taking into account the existing situation on the market and Directives 2006/125/EC 
and 2006/141/EC, and Regulation (EC) No 953/2009, it is appropriate to establish and 
include in the Annex to this Regulation a Union list of substances belonging to the 
following categories of substances: vitamins, minerals, amino acids, carni tine and taurine, 
nucleotides, choline and inositol. Among the substances belonging to those categor ies, it 
should only be permissible for those included in the Union list to be added to the cate gories 
of food covered by this Regulation. When substances are included in the Union list, it 
should be specified to which category of food covered by this Regulation such su bstances 
may be added.   
 
5394/1/13 REV 1  DPA/NC/vm 19 
 DG B 4  EMglyphffvm  (36) The inclusion of substances in the Union list should not mean that their addition to one or 
more categories of food covered by this Regulation is necessary or desirab le. The Union 
list is intended only to reflect which substances belonging to certain cate gories of 
substances are authorised to be added to one or more categories of food covered b y this 
Regulation, whereas the specific compositional requirements are intended t o establish the 
composition of each category of food covered by this Regulation. 
(37) A number of the substances that may be added to food covered by this Regulat ion could be 
added for technological purposes as food additives, colourings or flavourings, or for othe r 
such purposes, including authorised oenological practices and processes, provided for by 
relevant Union legal acts applicable to food. In this context specifications a re adopted for 
those substances at Union level. It is appropriate that those specific ations should be 
applicable to the substances whatever the purpose of their use in food unless  otherwise 
provided for by this Regulation. 
(38) For the substances included in the Union list for which purity criteria h ave not yet been 
adopted at Union level, and in order to ensure a high level of protection of public hea lth, 
generally acceptable purity criteria recommended by internati onal organisations or 
agencies including but not limited to the Joint FAO/WHO  Expert Committee on Food 
Additives (JECFA) and European Pharmacopoeia should apply. Member States s hould be 
permitted to maintain national rules setting stricter purity criteri a, without prejudice to the 
rules set out in the TFEU.    
 
5394/1/13 REV 1  DPA/NC/vm 20 
 DG B 4  EMglyphffvm  (39) In order to specify requirements for the categories of food covered by this Regulation, the 
power to adopt acts in accordance with Article 290 TFEU should be delegated to t he 
Commission in respect of the laying down of specific compositional and inform ation 
requirements with regard to the categories of food covered by this Regulati on, including 
additional labelling requirements to, or derogations from, Regulation (EU) No 1169/2011 
and with regard to the authorisation of nutrition and health claims. Furthermore, in order  to 
enable consumers to benefit rapidly from technical and scientific prog ress, especially in 
relation to innovative products, and thus to stimulate innovation the power to adopt acts  in 
accordance with Article 290 TFEU should also be delegated to the Commission in re spect 
of the regular updating of those specific requirements, taking into account all  relevant data, 
including data provided by interested parties. In addition, in order to take into acc ount 
technical progress, scientific developments or consumers' health, the p ower to adopt acts in 
accordance with Article 290 TFEU should be delegated to the Commission in respe ct of 
the addition of categories of substances that have a nutritional or physiologi cal effect to be 
covered by the Union list, or in respect of the removal of such categories from the  
categories of substances covered by the Union list. For the same purpose s and subject to 
additional requirements laid down in this Regulation, the power to adopt delegated act s in 
accordance with Article 290 TFEU should also be delegated to the Commission in re spect 
of amending the Union list by adding a new substance, removing a substance o r adding, 
removing or amending the elements in the Union list related to a substance. I t is of 
particular importance that the Commission carry out appropriate consul tations during its 
preparatory work, including at expert level. The Commission, when preparing  and drawing 
up delegated acts, should ensure a simultaneous, timely and appropriate trans mission of 
relevant documents to the European Parliament and to the Council.  
 
5394/1/13 REV 1  DPA/NC/vm 21 
 DG B 4  EMglyphffvm  (40) In order to ensure uniform conditions for the implementation of this Regulation,  
implementing powers should be conferred on the Commission to decide whether a given 
food falls within the scope of this Regulation and to which category of food it belong s. 
Those powers should be exercised in accordance with Regulation (EU) No 182 /2011 of the 
European Parliament and of the Council of 16 February 2011 laying down the rules and 
general principles concerning mechanisms for control by Member Sta tes of the 
Commission's exercise of implementing powers 1. 
                                                 
1 OJ L 55, 28.2.2011, p. 13.  
 
5394/1/13 REV 1  DPA/NC/vm 22 
 DG B 4  EMglyphffvm  (41) Currently, the rules on the use of the statements 'gluten-free' and 'very l ow gluten' are 
specified in Regulation (EC) No 41/2009. That Regulation harmonises the information tha t 
is provided to consumers on the absence or reduced presence of gluten in food and sets 
specific rules for food that is specially produced, prepared and/or proc essed in order to 
reduce the gluten content of one or more gluten-containing ingredients or to subs titute such 
gluten-containing ingredients and other food that is made exclusively from ingredient s that 
are naturally free of gluten. Regulation (EU) No 1169/2011 sets out rules on informat ion to 
be provided for all food, including non-prepacked food, on the presence of ingredients, 
such as gluten-containing ingredients, with a scientifically proven alle rgenic or intolerance 
effect in order to enable consumers, particularly those suffering from a  food allergy or 
intolerance such as gluten-intolerant people, to make informed choices whi ch are safe for 
them. For the sake of clarity and consistency, the rules on the use of the statements  'gluten-
free' and 'very low gluten' should also be regulated under Regulation (EU)  No 1169/2011. 
The legal acts to be adopted pursuant to Regulation (EU) No 1169/2011, which are to 
transfer the rules on the use of the statements 'gluten-free' and 'very low  gluten', as 
contained in Regulation (EC) No 41/2009, should ensure at least the same level of 
protection for people who are intolerant to gluten as currently provided for under 
Regulation (EC) No 41/2009. That transfer of rules should be completed before this  
Regulation applies. Furthermore, the Commission should consider how to ensure that 
people who are intolerant to gluten are adequately informed of the difference between a 
food that is specially produced, prepared and/or processed in order to reduce  the gluten 
content of one or more gluten-containing ingredients and other food that is made 
exclusively from ingredients naturally free of gluten.   
 
5394/1/13 REV 1  DPA/NC/vm 23 
 DG B 4  EMglyphffvm  (42) Labelling and compositional rules indicating the absence or reduced pr esence of lactose in 
food are currently not harmonised at Union level. Those indications are, however, 
important for people who are intolerant to lactose. Regulation (EU) No 1169 /2011 sets out 
rules on information to be provided concerning substances with a scientifica lly proven 
allergenic or intolerant effect, to enable consumers, such as lactose-intole rant people, to 
make informed choices which are safe for them. For the sake of clarity an d consistency, 
the establishment of rules on the use of statements indicating the absence or re duced 
presence of lactose in food should be regulated under Regulation (EU) No 1169/2011, 
taking into account the Scientific Opinion of the Authority of 10 September 2010 on 
lactose thresholds in lactose intolerance and galactosaemia. 
(43) 'Meal replacement for weight control' intended to replace part of the  daily diet is 
considered as food for particular nutritional uses and is currently governed by  specific 
rules under Directive 96/8/EC. However, more and more foods intended for the general 
population have appeared on the market carrying similar statements which a re presented as 
health claims for weight control. In order to eliminate any potential confus ion within this 
group of foods marketed for weight control and in the interests of legal cert ainty and 
coherence of Union legal acts, such statements should be regulated solely unde r Regulation 
(EC) No 1924/2006 and comply with requirements set out in that Regulation. It is 
necessary that technical adaptations made pursuant to Regulation (EC) No 1924 /2006, 
relating to health claims referring to control of body weight and made in r espect of food 
presented as 'meal replacement for weight control', and to the conditions of use  of such 
claims, as regulated by Directive 96/8/EC, be completed prior to the ap plication of 
this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 24 
 DG B 4  EMglyphffvm  (44) This Regulation does not affect the obligation to respect fundamental right s and 
fundamental legal principles, including the freedom of expression, as enshrine d in 
Article 11, in conjunction with Article 52, of the Charter of Fundamental Rights of t he 
European Union, and in other relevant provisions.  
(45) Since the objectives of this Regulation, namely, the establishment of com positional and 
information requirements for certain categories of food, the establishment of a  Union list of 
substances that may be added to certain categories of food and the establi shment of the 
rules for the update of the Union list, cannot be sufficiently achieved by t he Member States 
and can therefore, by reason of the scale of the proposed action, be better  achieved at 
Union level, the Union may adopt measures, in accordance with the principle of 
subsidiarity as set out in Article 5 of the Treaty on European Union. In accorda nce with the 
principle of proportionality, as set out in that Article, this Regulation does  not go beyond 
what is necessary in order to achieve those objectives. 
(46) Directive 92/52/EEC provides that infant formulae and follow-on formulae ex ported or 
re-exported from the Union are to comply with Union law unless otherwise requeste d or 
stipulated by provisions established by the importing country. That p rinciple has already 
been established for food in Regulation (EC) No 178/2002. For the sake of simplifi cation 
and legal certainty, Directive 92/52/EEC should therefore be repealed.   
 
5394/1/13 REV 1  DPA/NC/vm 25 
 DG B 4  EMglyphffvm  (47) Directives 96/8/EC, 1999/21/EC, 2006/125/EC, 2006/141/EC, 2009/39/EC and 
Regulations (EC) No 41/2009 and (EC) No 953/2009 should also be repealed.  
(48) Adequate transitional measures are necessary to enable food business op erators to adapt to 
the requirements of this Regulation, 
HAVE ADOPTED THIS REGULATION:  
 
5394/1/13 REV 1  DPA/NC/vm 26 
 DG B 4  EMglyphffvm  CHAPTER I 
GEMglyphffvmERAL PROVISIOMglyphffvmS 
Article 1 
Subject matter 
1. This Regulation establishes compositional and information requirements for  the following 
categories of food: 
(a) infant formula and follow-on formula; 
(b) processed cereal-based food and baby food; 
(c) food for special medical purposes; 
(d) total diet replacement for weight control. 
2. This Regulation establishes a Union list of substances that may be adde d to one or more of 
the categories of food referred to in paragraph 1 and lays down the rules applica ble to the 
updating of that list.  
 
5394/1/13 REV 1  DPA/NC/vm 27 
 DG B 4  EMglyphffvm  Article 2 
Definitions 
1. For the purposes of this Regulation, the following definitions shall apply: 
(a) the definitions of 'food', ‘food business operator’, 'retail' and 'pla cing on the market' 
set out respectively in Article 2 and points (3), (7) and (8) of Article 3 of Regul ation 
(EC) No 178/2002;  
(b) the definitions of 'prepacked food', 'labelling' and 'engineered nanomat erial' set out 
respectively in points (e), (j) and (t) of Article 2(2) of Regulation (EU )  
No 1169/2011;  
(c) the definitions of 'nutrition claim' and 'health claim' set out respec tively in points (4) 
and (5) of Article 2(2) of Regulation (EC) No 1924/2006. 
2. The following definitions shall also apply: 
(a) 'infant' means a child under the age of 12 months;  
 
5394/1/13 REV 1  DPA/NC/vm 28 
 DG B 4  EMglyphffvm  (b) 'young child' means a child aged between one and three years; 
(c) 'infant formula' means food intended for use by infants during the first m onths of life 
and satisfying by itself the nutritional requirements of such infants until t he 
introduction of appropriate complementary feeding;   
(d) 'follow-on formula' means food intended for use by infants when appropriat e 
complementary feeding is introduced and which constitutes the principal liqui d 
element in a progressively diversified diet of such infants; 
(e) 'processed cereal-based food' means food:  
(i) intended to fulfil the particular requirements of infants in good health while  
they are being weaned, and of young children in good health as a supplement 
to their diet and/or for their progressive adaptation, to ordinary food; and 
(ii) pertaining to one of the following categories:  
– simple cereals which are or have to be reconstituted with milk or other 
appropriate nutritious liquids, 
– cereals with an added high protein food which are or have to be 
reconstituted with water or other protein-free liquid,  
 
5394/1/13 REV 1  DPA/NC/vm 29 
 DG B 4  EMglyphffvm  – pastas which are to be used after cooking in boiling water or other 
appropriate liquids, 
– rusks and biscuits which are to be used either directly or, after 
pulverisation, with the addition of water, milk or other suitable liquids; 
(f) 'baby food' means food intended to fulfil the particular requirements of  infants in 
good health while they are being weaned, and of young children in good health as a 
supplement to their diet and/or for their progressive adaptation to ordinary food, 
excluding: 
(i) processed cereal-based food; and 
(ii) milk-based drinks and similar products intended for young children; 
(g) 'food for special medical purposes' means food specially process ed or formulated and 
intended for the dietary management of patients, including infants, to be used under  
medical supervision; it is intended for the exclusive or partial feeding  of patients with 
a limited, impaired or disturbed capacity to take, digest, absorb, metabol ise or 
excrete ordinary food or certain nutrients contained therein, or  metabolites, or with 
other medically-determined nutrient requirements, whose dietary manage ment 
cannot be achieved by modification of the normal diet alone;  
 
5394/1/13 REV 1  DPA/NC/vm 30 
 DG B 4  EMglyphffvm  (h) 'total diet replacement for weight control' means food specially f ormulated for use in 
energy restricted diets for weight reduction which, when used as instructed by the 
food business operator, replaces the whole daily diet. 
Article 3 
Interpretation decisions 
In order to ensure the uniform implementation of this Regulation, the Commission may  decide, by 
means of implementing acts: 
(a) whether a given food falls within the scope of this Regulation; 
(b) to which specific category of food referred to in Article 1(1) a giv en food belongs.  
Those implementing acts shall be adopted in accordance with the examinati on procedure referred to 
in Article 17(2).  
 
5394/1/13 REV 1  DPA/NC/vm 31 
 DG B 4  EMglyphffvm  Article 4 
Placing on the market 
1. Food referred to in Article 1(1) may only be placed on the market if it complie s with this 
Regulation. 
2. Food referred to in Article 1(1) shall only be allowed on the retail market in the f orm of 
prepacked  food. 
3. Member States may not restrict or forbid the placing on the market of food whi ch complies 
with this Regulation, for reasons related to its composition, manufacture, pres entation 
or labelling. 
Article 5 
Precautionary principle 
In order to ensure a high level of health protection in relation to the persons for  whom the food 
referred to in Article 1(1) of this Regulation is intended, the precautionary pr inciple as set out in 
Article 7 of Regulation (EC) No 178/2002 shall apply.   
 
5394/1/13 REV 1  DPA/NC/vm 32 
 DG B 4  EMglyphffvm  CHAPTER II 
COMPOSITIOMglyphffvmAL AMglyphffvmD IMglyphffvmFORMATIOMglyphffvm REQUIREMEMglyphffvmTS 
SECTIOMglyphffvm  1 
GEMglyphffvmERAL REQUIREMEMglyphffvmTS  
Article 6 
General provisions 
1. Food referred to in Article 1(1) shall comply with any requirement of Union la w applicable 
to food.  
2. The requirements laid down in this Regulation shall prevail over any conflict ing 
requirement of Union law applicable to food.  
 
5394/1/13 REV 1  DPA/NC/vm 33 
 DG B 4  EMglyphffvm  Article 7 
Opinions of the Authority 
The Authority shall provide scientific opinions in accordance with Article s 22 and 23 of Regulation 
(EC) No 178/2002 for the purpose of the application of this Regulation. Those opinions s hall serve 
as the scientific basis for any Union measure adopted pursuant to this R egulation which is likely to 
have an effect on public health. 
Article 8  
Access to documents 
The Commission shall apply Regulation (EC) No 1049/2001 of the European Parliament  and of the 
Council of 30 May 2001 regarding public access to European Parliament, Council  and Commission 
documents 1 to applications for access to any document covered by this Regulation. 
Article 9 
General compositional and information requirements 
1. The composition of food referred to in Article 1(1) shall be such that it is appro priate for 
satisfying the nutritional requirements of, and is suitable for, the persons  for whom it is 
intended, in accordance with generally accepted scientific data. 
                                                 
1 OJ L 145, 31.5.2001, p. 43.  
 
5394/1/13 REV 1  DPA/NC/vm 34 
 DG B 4  EMglyphffvm  2. Food referred to in Article 1(1) shall not contain any substance in such quantity as  to 
endanger the health of the persons for whom it is intended. 
For substances which are engineered nanomaterials, compliance with the requi rement 
referred to in the first subparagraph shall be demonstrated on the basis of  adequate test 
methods, where appropriate. 
3. On the basis of generally accepted scientific data, substances  added to food referred to in 
Article 1(1) for the purposes of the requirements under paragraph 1 of this  Article shall be 
bio-available for use by the human body, have a nutritional or physiologica l effect and  be 
suitable for the persons for whom the food is intended. 
4. Without prejudice to Article 4(1) of this Regulation, food referred to in Articl e 1(1) of this 
Regulation may contain substances covered by Article 1 of Regulation (EC)  No 258/97, 
provided that those substances fulfil the conditions under that Regulation for being  placed 
on the market. 
5. The labelling, presentation and advertising of food referred to in Article 1( 1) shall provide 
information for the appropriate use of such food, and shall not mislead, or attribute to s uch 
food the property of preventing, treating or curing a human disease, or im ply 
such properties.   
 
5394/1/13 REV 1  DPA/NC/vm 35 
 DG B 4  EMglyphffvm  6. Paragraph 5 shall not prevent the dissemination of any useful information or 
recommendations exclusively intended for persons having qualifications in medic ine, 
nutrition, pharmacy, or for other healthcare professionals responsible for m aternal care and 
childcare. 
Article 10 
Additional requirements for infant formula and follow-on formula 
1. The labelling, presentation and advertising of infant formula and follow-on form ula shall 
be designed so as not to discourage breast-feeding. 
2. The labelling, presentation and advertising of infant formula, and the labelli ng of follow-on 
formula shall not include pictures of infants, or other pictures or text which ma y idealise 
the use of such formulae.  
Without prejudice to the first subparagraph, graphic representations f or easy identification 
of infant formula and follow-on formula and for illustrating methods of preparati on shall 
be permitted.  
 
5394/1/13 REV 1  DPA/NC/vm 36 
 DG B 4  EMglyphffvm  SECTIOMglyphffvm  2 
SPECIFIC REQUIREMEMglyphffvmTS  
Article 11 
Specific compositional and information requirements 
1. Subject to the general requirements set out in Articles 6 and 9, to the additional  
requirements of Article 10, and taking into account relevant technical and scienti fic 
progress, the Commission shall be empowered to adopt delegated acts in acc ordance with 
Article 18, with respect to the following: 
(a) the specific compositional requirements applicable to food referre d to in Article 1(1), 
with the exception of requirements as set out in the Annex;   
(b) the specific requirements on the use of pesticides in products intended for  the 
production of food referred to in Article 1(1) and on pesticide residues in such food. 
The specific requirements for the categories of food referred to in points  (a) and (b) 
of Article 1(1) and food for special medical purposes developed to satisfy  the 
nutritional requirements of infants and young children shall be updated regularl y and 
include, inter alia, provisions to restrict the use of pesticides as much as p ossible; 
(c) the specific requirements on labelling, presentation and advertisin g of food referred 
to in Article 1(1), including the authorisation of nutrition and health claims in 
relation thereto;  
 
5394/1/13 REV 1  DPA/NC/vm 37 
 DG B 4  EMglyphffvm  (d) the notification requirements for the placing on the market of food referr ed to in 
Article 1(1), in order to facilitate the efficient official monitoring of suc h food, and 
on the basis of which food business  operators shall notify the competent authorities 
of Member States where that food is being marketed;  
(e) the requirements concerning promotional and commercial practices r elating to infant 
formula;  
(f) the requirements concerning information to be provided in relation to infant  and 
young child feeding in order to ensure adequate information on appropriate 
feeding practices; 
(g) the specific requirements for  food for special medical purposes developed to satisfy 
the nutritional requirements of infants, including compositional requirements and 
requirements on the use of pesticides in products intended for the production of suc h 
food, pesticide residues, labelling, presentation, advertising, and promoti onal and 
commercial practices, as appropriate.  
These delegated acts shall be adopted by…*. 
                                                 
* OJ: please insert the date: 2 years after the date of entry into forc e of this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 38 
 DG B 4  EMglyphffvm  2. Subject to the general requirements set out in Articles 6 and 9, to the additional  
requirements of Article 10, and taking into account relevant technical and scienti fic 
progress, including data provided by interested parties in relation to innovati ve products, 
the Commission shall be empowered to adopt delegated acts in accordance with Article 18 
in order to update the acts referred to in paragraph 1 of this Article. 
Where in the case of emerging health risks, imperative grounds of urgency so re quire, the 
procedure provided for in Article 19 shall apply to delegated acts adopted pur suant to 
this paragraph. 
Article 12 
Milk-based drinks and similar products intended for young children 
By…* , the Commission shall, after consulting the Authority, present to the European  Parliament 
and to the Council a report on the necessity, if any, of special provisions for milk -based drinks and 
similar products intended for young children regarding compositional and labe lling requirements 
and, if appropriate, other types of requirements. The Commission shall conside r in the report, inter 
alia, the nutritional requirements of young children, the role of those products in t he diet of young 
children and whether those products have any nutritional benefits when compar ed to a normal diet 
for a child who is being weaned. Such a report may, if necessary, be accom panied by an appropriate 
legislative proposal. 
                                                 
* OJ: please insert the date: 2 years after the date of entry into forc e of this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 39 
 DG B 4  EMglyphffvm  Article 13 
Food intended for sportspeople 
By  … ∗∗ ∗∗, the Commission shall, after consulting the Authority, present to t he European Parliament 
and to the Council a report on the necessity, if any, of provisions f or food intended for sportspeople. 
Such a report may, if necessary, be accompanied by an appropriate l egislative proposal. 
Article 14 
Technical guidelines 
The Commission may adopt technical guidelines to facilitate complianc e by food business 
operators, in particular SMEs, with this Chapter and Chapter III. 
                                                 
∗∗ ∗∗ OJ: please insert the date: 2 years after the date of entry into forc e of this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 40 
 DG B 4  EMglyphffvm  CHAPTER III 
UMglyphffvmIOMglyphffvm LIST  
Article 15 
Union list  
1. Substances belonging to the following categories of substances may be added to one or 
more of the categories of food referred to in Article 1(1), provided that these su bstances are 
included in the Union list set out in the Annex and comply with the elements contained in 
the Union list in accordance with paragraph 3 of this Article: 
(a) vitamins; 
(b) minerals; 
(c) amino acids; 
(d) carnitine and taurine; 
(e) nucleotides; 
(f) choline and inositol.  
 
5394/1/13 REV 1  DPA/NC/vm 41 
 DG B 4  EMglyphffvm  2. Substances that are included in the Union list shall meet the general requirem ents set out in 
Articles 6 and 9 and, where applicable, the specific requirements establis hed in accordance 
with Article 11.  
3. The Union list shall contain the following elements: 
(a) the category of food referred to in Article 1(1) to which substances be longing to the 
categories of substances listed in paragraph 1 of this Article may  be added; 
(b) the name, the description of the substance and, where appropriate, the s pecification 
of its form; 
(c) where appropriate, the conditions of use of the substance; 
(d) where appropriate, the purity criteria applicable to the sub stance.   
 
5394/1/13 REV 1  DPA/NC/vm 42 
 DG B 4  EMglyphffvm  4. Purity criteria established by Union law applicable to food, which apply  to the substances 
included in the Union list when they are used in the manufacture of food for purposes other  
than those covered by this Regulation, shall also apply to those substances when the y are 
used for purposes covered by this Regulation unless otherwise specified in this  Regulation. 
5. For substances included in the Union list for which purity criteria are not est ablished by 
Union law applicable to food, generally acceptable purity criteria re commended by 
international bodies shall apply until the establishment of such criteria.  
Member States may maintain national rules setting stricter purity c riteria. 
6. In order to take into account technical progress, scientific development s or the protection 
of consumers' health, the Commission shall be empowered to adopt, in relation to t he 
categories of substances listed in paragraph 1 of this Article, dele gated acts in accordance 
with Article 18 with respect to the following:  
(a) the removal of a category of substances;  
(b) the addition of a category of substances that have a nutritional or 
physiological effect.  
 
5394/1/13 REV 1  DPA/NC/vm 43 
 DG B 4  EMglyphffvm  7. Substances belonging to categories not listed in paragraph 1 of this A rticle may be added 
to food referred to in Article 1(1), provided that they satisfy the general re quirements set 
out in Articles 6 and 9 and, where applicable, the specific requirements estab lished in 
accordance with Article 11. 
Article 16 
Updating the Union list 
1. Subject to the general requirements set out in Articles 6 and 9 and, where ap plicable, the 
specific requirements established in accordance with Article 11, and in order  to take into 
account technical progress, scientific developments  or the protection of consumers' health, 
the Commission shall be empowered to adopt delegated acts in accordance with Article 18, 
to amend the Annex, with respect to the following: 
(a) the addition of a substance to the Union list; 
(b) the removal of a substance from the Union list; 
(c) the addition, removal or amendment of the elements referred to in Article 15 (3). 
2. Where, in the case of emerging health risks, imperative grounds of urgency so requir e, the 
procedure provided for in Article 19 shall apply to delegated acts adopted pur suant to 
this Article.  
 
5394/1/13 REV 1  DPA/NC/vm 44 
 DG B 4  EMglyphffvm  CHAPTER IV 
PROCEDURAL PROVISIOMglyphffvmS 
Article 17 
Committee procedure 
1. The Commission shall be assisted by the Standing Committee on the Food Chain a nd 
Animal Health established by Regulation (EC) No 178/2002. That committee shal l be a 
committee within the meaning of Regulation (EU) No 182/2011. 
2. Where reference is made to this paragraph, Article 5 of Regulation (EU)  No 182/2011 
shall apply. 
Where the opinion of the committee is to be obtained by written procedure, t hat procedure 
shall be terminated without result when, within the time-limit for delivery  of the opinion, 
the chair of the committee so decides or a simple majority of committee  members 
so request.  
 
5394/1/13 REV 1  DPA/NC/vm 45 
 DG B 4  EMglyphffvm  Article 18 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the  
conditions laid down in this Article. 
2. The power to adopt delegated acts referred to in Article 11, Article 15(6) a nd Article 16(1) 
shall be conferred on the Commission for a period of five years from …*. The Commission 
shall draw up a report in respect of the delegation of power not later than nine  months 
before the end of the five-year period. The delegation of power shall be ta citly extended for 
periods of an identical duration, unless the European Parliament or the Council oppose s 
such extension not later than three months before the end of each period. 
3. The delegation of power referred to in Article 11, Article 15(6) and Artic le 16(1) may be 
revoked at any time by the European Parliament or by the Council. A decision to revoke 
shall put an end to the delegation of the power specified in that decision. It shall  take effect 
the day following the publication of the decision in the Official Journal of the 
European Union  or at a later date specified therein. It shall not affect the validity of a ny 
delegated acts already in force. 
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneousl y to the 
European Parliament and to the Council. 
                                                 
* OJ: please insert the date of entry into force of this Regulation  
 
5394/1/13 REV 1  DPA/NC/vm 46 
 DG B 4  EMglyphffvm  5. A delegated act adopted pursuant to Article 11, Article 15(6) and Article 1 6(1) shall enter 
into force only if no objection has been expressed either by the European Parl iament or the 
Council within a period of two months of notification of that act to the 
European Parliament and the Council or if, before the expiry of that period, t he 
European Parliament and the Council have both informed the Commission that they wi ll 
not object. That period shall be extended by two months at the initiative of the  
European Parliament or of the Council. 
Article 19 
Urgency procedure 
1. Delegated acts adopted under this Article shall enter into force without de lay and shall 
apply as long as no objection is expressed in accordance with paragraph 2. The  notification 
of a  delegated act to the European Parliament and to the Council shall state the reas ons for 
the use of the urgency procedure. 
2. Either the European Parliament or the Council may object to a delegated act i n accordance 
with the procedure referred to in Article 18(5). In such a case, the Commission sha ll repeal 
the act without delay following the notification of the decision to object by the 
European Parliament or by the Council.  
 
5394/1/13 REV 1  DPA/NC/vm 47 
 DG B 4  EMglyphffvm  CHAPTER V 
FIMglyphffvmAL PROVISIOMglyphffvmS 
Article 20 
Repeal 
1. Directive 2009/39/EC is repealed with effect from …*. References to the repealed act shall 
be construed as references to this Regulation. 
2. Directive 92/52/EEC and Regulation (EC) No 41/2009 are repealed with effect fr om …*. 
3. Without prejudice to the first subparagraph of paragraph 4, Directive 96/8/E C shall not 
apply from ... * to foods presented as a replacement for one or more meals of the daily diet. 
4. Regulation (EC) No 953/2009 and Directives 96/8/EC, 1999/21/EC, 2006/125/EC 
and 2006/141/EC are repealed from the date of application of the delegated acts re ferred to 
in Article 11(1). 
In the case of conflict between Regulation (EC) No 953/2009, Directives 96/8/EC , 
1999/21/EC, 2006/125/EC, 2006/141/EC and this Regulation, this Regulation shall prevail. 
                                                 
* OJ: please insert the date: 3 years after the date of entry into forc e of this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 48 
 DG B 4  EMglyphffvm  Article 21 
Transitional measures 
1. Food referred to in Article 1(1) of this Regulation which does not comply with this 
Regulation but complies with Directive 2009/39/EC, and, as applicable, with Re gulation 
(EC) No 953/2009 and Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, 
and which is placed on the market or labelled before … * may continue to be marketed 
after that date until stocks of such food are exhausted.  
Where the date of application of the delegated acts referred to in Article 11( 1) of this 
Regulation is after …*, food referred to in Article 1(1) which complies with this 
Regulation and, as applicable, with Regulation (EC) No 953/2009 and Directives 96/8/EC , 
1999/21/EC, 2006/125/EC and 2006/141/EC but does not comply with those delegated 
acts, and which is placed on the market or labelled before the date of appli cation of those 
delegated acts, may continue to be marketed after that date until stocks of suc h food 
are exhausted. 
                                                 
* OJ: please insert the date: 3 years after the date of entry into forc e of this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 49 
 DG B 4  EMglyphffvm  2. Food which is not referred to in Article 1(1) of this Regulation but which is place d on the 
market or labelled in accordance with Directive 2009/39/EC and Regulation (EC)  
No 953/2009, and, as applicable, with Directive 96/8/EC and Regulation (EC) No 41/2009 
before…* may continue to be marketed after that date until stocks of such food are 
exhausted. 
Article 22 
Entry into force 
This Regulation shall enter into force on the twentieth day following that of its publication in the 
Official Journal of the European Union . 
It shall apply from …*, with the exception of the following: 
– Articles 11, 16, 18 and 19 which shall apply from …** ; 
– Article 15 and the Annex to this Regulation which shall apply from the date of applic ation 
of the delegated acts referred to in Article 11(1).  
                                                 
* OJ: please insert the date: 3 years after the date of entry into forc e of this Regulation. 
**  OJ: please insert the date of entry into force of this Regulation.  
 
5394/1/13 REV 1  DPA/NC/vm 50 
 DG B 4  EMglyphffvm  This Regulation shall be binding in its entirety and directly applicab le in all Member States. 
Done at ..., 
For the European Parliament For the Council 
The President The President 
  
 
5394/1/13 REV 1  DPA/NC/vm 1 
ANNEX DG B 4  EMglyphffvm  AMglyphffvmMglyphffvmEX  
Union list as referred to in Article 15(1) 
Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Vitamins       
Vitamin A      
retinol X X X X 
retinyl acetate X X X X 
retinyl palmitate X X X X  
beta-carotene  X X X 
Vitamin D      
ergocalciferol X X X X  
 
cholecalciferol X X X X  
 
5394/1/13 REV 1  DPA/NC/vm 2 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Vitamin E      
D-alpha tocopherol X X X X 
DL-alpha tocopherol X X X X 
D-alpha tocopheryl 
acetate X X X X 
DL-alpha tocopheryl 
acetate X X X X 
D-alpha-tocopheryl 
acid succinate   X X  
D-alpha-tocopheryl 
polyethylene glycol-
1000 succinate 
(TPGS)   X  
Vitamin K      
phylloquinone 
(phytomenadione) X X X X  
 
menaquinone (1)   X X  
 
5394/1/13 REV 1  DPA/NC/vm 3 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Vitamin C      
L-ascorbic acid X X X X 
sodium-L-ascorbate X X X X 
calcium-L-ascorbate X X X X 
potassium-L-
ascorbate X X X X  
L-ascorbyl 6-
palmitate X X X X 
Thiamin      
thiamin hydrochloride X X X X 
 
thiamin mononitrate X X X X 
Riboflavin      
riboflavin X X X X  
 
riboflavin 5'-
phosphate, sodium X X X X  
 
5394/1/13 REV 1  DPA/NC/vm 4 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Niacin      
nicotinic acid X X X X 
 
nicotinamide X X X X 
Vitamin B 6      
pyridoxine 
hydrochloride X X X X 
pyridoxine 5'-
phosphate X X X X  
pyridoxine 
dipalmitate  X X X 
Folate      
folic acid 
(pteroylmonoglutamic 
acid) X X X X  
 
calcium-L-
methylfolate   X X  
 
5394/1/13 REV 1  DPA/NC/vm 5 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Vitamin B 12       
cyanocobalamin X X X X 
 
hydroxocobalamin X X X X 
Biotin      
 D-biotin X X X X 
Pantothenic 
Acid      
D-pantothenate, 
calcium X X X X 
D-pantothenate, 
sodium X X X X  
 
dexpanthenol X X X X  
 
5394/1/13 REV 1  DPA/NC/vm 6 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Minerals       
 Potassium      
potassium 
bicarbonate X  X X 
potassium carbonate X  X X 
potassium chloride X X X X 
potassium citrate X X X X 
potassium gluconate X X X X 
potassium 
glycerophosphate  X X X 
potassium lactate X X X X 
potassium hydroxide X  X X 
potassium salts of 
orthophosphoric acid X  X X   
magnesium potassium 
citrate   X X  
 
5394/1/13 REV 1  DPA/NC/vm 7 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Calcium      
calcium carbonate X X X X 
calcium chloride X X X X 
calcium salts of citric 
acid X X X X 
calcium gluconate X X X X 
calcium 
glycerophosphate X X X X 
calcium lactate X X X X 
calcium salts of 
orthophosphoric acid X X X X 
calcium hydroxide X X X X 
calcium oxide  X X X 
calcium sulphate   X X 
calcium bisglycinate   X X 
calcium citrate malate   X X 
calcium malate   X X  
 
calcium L-pidolate   X X  
 
5394/1/13 REV 1  DPA/NC/vm 8 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Magnesium      
magnesium acetate   X X 
magnesium carbonate X X X X 
magnesium chloride X X X X 
magnesium salts of 
citric acid X X X X 
magnesium gluconate X X X X 
magnesium 
glycerophosphate  X X X 
magnesium salts of 
orthophosphoric acid X X X X 
magnesium lactate  X X X 
magnesium hydroxide X X X X 
magnesium oxide X X X X  
 
magnesium sulphate X X X X  
 
5394/1/13 REV 1  DPA/NC/vm 9 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
magnesium L-
aspartate   X  
magnesium 
bisglycinate   X X 
magnesium L-
pidolate   X X   
magnesium potassium 
citrate   X X  
 
5394/1/13 REV 1  DPA/NC/vm 10 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Iron      
ferrous carbonate  X X X 
ferrous citrate X X X X 
ferric ammonium 
citrate X X X X 
ferrous gluconate X X X X 
ferrous fumarate X X X X 
ferric sodium 
diphosphate  X X X 
ferrous lactate X X X X 
ferrous sulphate X X X X 
ferrous ammonium 
phosphate   X X 
ferric sodium EDTA   X X 
ferric diphosphate 
(ferric 
pyrophosphate) X X X X  
 
ferric saccharate  X X X  
 
5394/1/13 REV 1  DPA/NC/vm 11 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
elemental iron 
(carbonyl + 
electrolytic + 
hydrogen reduced)  X X X 
 
ferrous bisglycinate X  X X 
 ferrous L-pidolate   X X 
Zinc      
zinc acetate X X X X 
zinc chloride X X X X 
zinc citrate X X X X 
zinc gluconate X X X X 
zinc lactate X X X X 
zinc oxide X X X X 
zinc carbonate   X X 
zinc sulphate X X X X  
 
zinc bisglycinate   X X  
 
5394/1/13 REV 1  DPA/NC/vm 12 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Copper      
cupric carbonate X X X X 
cupric citrate X X X X 
cupric gluconate X X X X 
cupric sulphate X X X X  
copper lysine 
complex X X X X 
Manganese      
manganese carbonate X X X X 
manganese chloride X X X X 
manganese citrate X X X X 
manganese gluconate X X X X 
manganese 
glycerophosphate  X X X  
 
manganese sulphate X X X X  
 
5394/1/13 REV 1  DPA/NC/vm 13 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Fluoride      
potassium fluoride   X X 
 
sodium fluoride   X X 
Selenium      
sodium selenate X  X X 
sodium hydrogen 
selenite   X X 
sodium selenite X  X X  
selenium enriched 
yeast (2)   X X 
Chromium      
chromium (III) 
chloride and its 
hexahydrate   X X 
chromium (III) 
sulphate and its 
hexahydrate   X X  
 
chromium picolinate   X X  
 
5394/1/13 REV 1  DPA/NC/vm 14 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Molybdenum      
ammonium 
molybdate   X X 
 
sodium molybdate   X X 
Iodine      
potassium iodide X X X X 
potassium iodate X X X X 
sodium iodide X X X X  
 
sodium iodate  X X X  
 
5394/1/13 REV 1  DPA/NC/vm 15 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Sodium      
sodium bicarbonate X  X X 
sodium carbonate X  X X 
sodium chloride X  X X 
sodium citrate X  X X 
sodium gluconate X  X X 
sodium lactate X  X X 
sodium hydroxide X  X X  
sodium salts of 
orthophosphoric acid X  X X 
Boron      
sodium borate   X X  
 
boric acid   X X  
 
5394/1/13 REV 1  DPA/NC/vm 16 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Amino acids (3)       
  L-alanine  - X X 
 L-arginine X 
and its 
hydrochloride X 
and its 
hydrochloride X X 
 L-aspartic acid   X  
 L-citrulline   X  
 L-cysteine X 
and its 
hydrochloride X 
and its 
hydrochloride X X 
 Cystine (4) X 
and its 
hydrochloride X 
and its 
hydrochloride X X  
 L-histidine X 
and its 
hydrochloride X 
and its 
hydrochloride X X  
 
5394/1/13 REV 1  DPA/NC/vm 17 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
 L-glutamic acid   X X 
 L-glutamine   X X 
 glycine   X  
 L-isoleucine X 
and its 
hydrochloride X 
and its 
hydrochloride X X 
 L-leucine X 
and its 
hydrochloride X 
and its 
hydrochloride X X 
 L-lysine X 
and its 
hydrochloride X 
and its 
hydrochloride X X 
 L-lysine acetate   X X 
 L-methionine X X X X 
 L-ornithine   X X 
 L-phenylalanine X X X X  
 L-proline   X   
 
5394/1/13 REV 1  DPA/NC/vm 18 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
 L-threonine X X X X 
 L-tryptophan X X X X  
 L-tyrosine X X X X 
 L-valine X X X X 
 L-serine   X  
 L-arginine-L-
aspartate   X  
 L-lysine-L-aspartate   X  
 L-lysine-L-glutamate   X  
 N-acetyl-L-cysteine   X   
 N-acetyl-L-
methionine   X (in 
products 
intended 
for 
persons 
over 1 
year of 
age)   
 
5394/1/13 REV 1  DPA/NC/vm 19 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Carnitine and 
taurine       
 L-carnitine X X X X 
 L-carnitine 
hydrochloride X X X X 
 taurine X  X X  
 L-carnitine-L-tartrate X  X X  
 
5394/1/13 REV 1  DPA/NC/vm 20 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Nucleotides       
 adenosine 5'-
phosphoric acid 
(AMP) X  X X 
 sodium salts of AMP X  X X 
 cytidine 5'-
monophosphoric acid 
(CMP) X  X X 
 sodium salts of CMP X  X X 
 guanosine 5'-
phosphoric acid 
(GMP) X  X X 
 sodium salts of GMP X  X X 
 inosine 5'-phosphoric 
acid (IMP) X  X X 
 sodium salts of IMP X  X X 
 uridine 5'-phosphoric 
acid (UMP) X  X X  
 sodium salts of UMP X  X X  
 
5394/1/13 REV 1  DPA/NC/vm 21 
ANNEX DG B 4  EMglyphffvm  Category of food 
Substance Infant 
formula and 
follow on 
formula Processed 
cereal-based 
food and baby 
food  Food for 
special 
medical 
purposes Total diet 
replacement 
for weight 
control 
Choline and 
inositol       
 choline X X X X 
 choline chloride X X X X 
 choline bitartrate X X X X 
 choline citrate X X X X  
 inositol X X X X 
  
 
5394/1/13 REV 1  DPA/NC/vm 22 
ANNEX DG B 4  EMglyphffvm  (1) Menaquinone occurring principally as menaquinone-7 and, to a minor extent, 
menaquinone-6. 
(2) Selenium-enriched yeasts produced by culture in the presence of sodium s elenite as 
selenium source and containing, in the dried form as marketed, not more than 2,5 mg Se/g. 
The predominant organic selenium species present in the yeast is selenome thionine 
(between 60 and 85 % of total extracted selenium in the product). The content of other 
organic selenium compounds including selenocysteine must not exceed 10 % of total 
extracted selenium. Levels of inorganic selenium normally must not exceed 1 % of t otal 
extracted selenium. 
(3) For amino acids used in infant formula, follow-on formula, processed cereal-ba sed food 
and baby food only the hydrochloride specifically mentioned may be used. For a mino acids 
used in food for special medical purposes and in total diet replacement for we ight control, 
as far as applicable, also the sodium, potassium, calcium and magnesium sal ts as well as 
their hydrochlorides may be used. 
(4) In the case of use in infant formula, follow-on formula, processed cereal-ba sed food and 
baby food, only the form L-cystine may be used.