EUROPEAN COMMISSION 
Brussels, 20.6.2011 
COM(2011) 353 final 
2011/0156 (COD)   
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on food intended for infants and young children and on food for special medical 
purposes  
(presented by the Comm ission pursuant to Article 114 of the Treaty on the Functioning 
of the European Union) 
(Text with EEA relevance) 
{SEC(2011) 762 final} 
{SEC(2011) 763 final} 
  
EN 1   EN EXPLANATORY MEMORANDUM  
1. C ONTEXT OF THE PROPOSAL  
• Grounds for and objectives of the proposal 
 The proposal revises the legislation on foodstuffs intended for particular 
nutritional uses covered by Directive 2009/39/EC the so-called "Framework 
Directive on dietetic foods". The pr ovisions of Direc tive 2009/39/EC were 
originally adopted in 1977. After seve ral amendments, a recast version was 
adopted in 2009 to include the rules of the new Comitology procedure.  
 Foodstuffs for particular nutritional uses are foods that are different from foods 
for normal consumption and are, as currently regulated, specially manufactured products intended to satisfy the particular  nutritional requirements of specific 
categories of the population. The designa tion under which a dietetic food is 
sold is accompanied by a suit ability statement for the pa rticular nutritional use 
and the specific group of the populati on to whom the f ood is intended, e .g.: 
gluten-free food for celia c people, processed cer eal-based food for young 
children, infant formulae for infants from birth etc. 
 After more than 30 years of applicati on, the evolution of both the food market 
and food legislation makes an overa ll revision necessary. Indeed, the 
application of the broad c oncept of "foodstuffs for pa rticular nutritional uses" 
on which the Framework Directive is ba sed in the evolved market and legal 
context has led to considerable problems for stakeholders and controlling authorities. The classification of many f oods as 'dietetic' foods and the need for 
such a category of foods has been  seriously questio ned, although the 
desirability of maintaining rules on certain specific cate gories of foods actually 
addressing nutritional benefits for cert ain sub-groups of the population is being 
recognised. 
 Consequently, in pursuing the obj ectives of better regulation and 
simplification, the proposal aims to rectify this situation by simplifying and clarifying the rules that appl y to products hitherto regulated as 'dietetic' foods, 
taking into account the evol ution of the regulatory measures in relevant areas. 
 Given the above, the proposal abolishe s the concept of di etetic foods and 
provides for a new framework establishing general provisions only for a limited number of well-estab lished and defined categories of food that are 
considered as essential for certain vulner able groups of the population, i.e. food 
intended for infants and young children and food for patients under medical supervision.  
 Further to these objectives, the propos al also aims at creating a single legal 
measure that regulates lists of substances such as vitamins, minerals and other substances that may be added to th e categories of food covered by this 
proposal. The currently existing three differe nt lists of substances included in 
three different legal measures would be combined into a single one. Clarity for  
EN 2   EN stakeholders and Member States and be tter Union administration would be the 
outcome of the establishment of such a merged measure. 
 The revision of the legislation is acc ompanied by an impact assessment giving 
an overview of the applica tion of Directive 2009/39/EC.  
• General context  
 The main objective of the Framework Di rective was to remove the differences 
between national laws relating to foodstu ffs for particular nutritional uses, thus 
allowing their free movement and creating fair conditions of competitions. 
 Discussions with Member States and st akeholders have highlighted increasing 
difficulties for implementing the Framework Directive, in particular in relation 
to more recent pieces of Union legisl ation such as the legislation on food 
supplements (Directive 2002/46/EC), on the addition of vitamins and minerals and other substances to foods  (Regulation (EC) No 1925/2006) and nutrition 
and health claims (Regulation (EC) No 1924/2006). In effect, as the food 
market evolved, so did the Union legislatio n governing it in order to ensure the 
functioning of the internal market and gua rantee the same level of protection to 
citizens across Europe. 
 This unclear situation has led also to di stortions of trade in the internal market 
due to different interpretation and enfo rcement of Directive 2009/39/EC across 
Member States and in particular regarding its scope of application. 
Furthermore, it appears that these more  recently adopted Union legislations 
mentioned above would adequately cove r all products addressing nutritional 
benefits for the general population and certain sub-groups thereof with less 
administrative burden and more clarity as to their scope. 
 As foreseen in the Framework Directiv e, Member States were asked for their 
views and experience on the implementa tion of certain pr ovisions of that 
Directive in order to prepare Commissi on reports on 1) the implementation of 
the notification procedure of the Framew ork Directive on diet etic foods and 2) 
the desirability of special provisions for foods for persons suffering from carbohydrate-metabolism disord ers (diabetic foods).  
 As regards foods for diabetic people, the Commission's report concludes that 
there is no scientific basis on whic h to develop specific compositional 
requirements for this category of food a nd that diabetic people should eat as 
healthily as possible choosing a diet  from a variety of food for normal 
consumption. Also, the report on the implementation of the notification 
procedure points out that the category of food regulated under that provision 
differs significantly between Member States creating as a result market 
distortions. On top, a company is re quested to notify to the competent 
authorities each product they want to ma rket as a 'dietetic' product and has to 
repeat that procedure in all the Member  States where they wish to place the 
product on the national market. The re sulting administra tive burden is 
significant for both the Member States and the company while the added value 
in terms of public health and cons umer information is questionable.  
EN 3   EN  All abovementioned issues led to the n eed to consider an in depth and global 
revision of the legisla tion on dietetic foods.  
• Existing provisions in the area of the proposal  
 The following pieces of legislation cover the area of foods for particular 
nutritional uses:  
– Directive 2009/39/EC on foodstuffs in tended for particular nutritional 
uses, "the Framework Dir ective on dietetic foods" . The Directive lays 
down a common definition on foods for pa rticular nutritional uses as well 
as general provisions (e.g. a general notification proce dure for categories 
for foods not covered by specific Commission legislation) and common labelling rules.  
 According to the definition, foods for particular nutritiona l uses are foods 
that are different from foods for no rmal consumption and are specially 
manufactured products intended to satisfy the particular nutritional 
requirements of specific cat egories of the population. 
 Specific measures adopted for certain categories of foods under that framework 
legislation are: 
– Commission Directive 2006/141/EC on in fant formulae and follow-on 
formulae . 
 This Directive was adopted originally in 1991 and revised globally in 
2006. It establishes detailed and comp lete compositional and labelling 
rules for products intended to infant s from birth up to 12 months of age. 
Infant formulae are suitable as the so le source of nourishment during first 
months of life if infants are not breastfed while follow-on formulae may 
constitute the principal liquid element in a progressively diversified diet. 
* Council Directive 92/52/EEC on infant  formulae and follow-on formulae 
intended for export to third countries  established the rules for infant 
formulae and follow-on formulae e xported or re-exported from the 
European Union to third countries. 
– Commission Directive 2006/125/EC on processed cereal-based foods 
and baby foods for infants and young children. 
 Directive 2006/125/EC was adopted or iginally in 1996 and was codified 
in 2006. This Directive covers foods th at are intended to be part of a 
diversified diet of infants and yo ung children. It lays down general 
compositional and labelling rules for a large diversity of products. No 
major changes have been introduced since its first date of adoption. 
– Commission Directive 1999/21/EC on di etary foods for special medical 
purposes. 
 Dietary foods for special medical pur poses are intended for the exclusive 
or partial feeding of pa tients with disturbed cap acity to take ordinary  
EN 4   EN food and whose dietary management cannot be achieved by modification 
of the normal diet or by other dietetic foods. It establishes general compositional criteria and quite detaile d labelling rules. These foods are 
to be used under medical supervisio n. No updates have been made since 
1999. 
– Commission Directive 96/8/EC on foods  intended for use in energy-
restricted diets for weight reduction.  
 This Directive covers two categor ies of products intended for weight 
control: products presented as a replacement for the whole daily diet and products presented as a replacement fo r one or more meals of the daily 
diet. 
 It sets general compositional and co mpulsory labelling rules for these 
products. 
– Commission Regulation (EC) No 41 /2009 concerning the composition 
and labelling of foodstuffs suitable for people intolerant to gluten. 
 This Regulation was adopted in 2009. A transitional peri od applies until 
1 January 2012. It fixes gluten thres holds and associated  labelling rules 
for the voluntary indication of the ab sence of gluten in products for 
people suffering from a permanent into lerance to gluten (coeliac people). 
The Regulation foresees that the statement 'gluten-free' can be used on foods for normal consumption as well. 
– Commission Regulation (EC) No 953/ 2009 on substances that may be 
added for specific nutritional purposes in foods for particular nutritional 
uses. 
 This Regulation adopted in 2009 updates and replaces Directive 
2001/15/EC and established a consolidated list of substances such as vitamins, minerals, and other substanc es that may be used in dietetic 
foods except those that can be used in infant formulae and follow-on 
formulae and in cereal-based foods  and other baby foods which are 
included in the relevant specific  Directives. The addition of new 
substances to that list is subjected to the scientific assessment of the European Food Safety Authority (EFSA). 
• Consistency with the other policies and objectives of the Union 
 The proposal is in line with the Commission's Better Regulation Policy, the 
Lisbon Strategy and the EU's Sustainable Development strategy. The emphasis is on simplifying the regulatory process,  thus reducing the administrative 
burden and improving the competitiven ess of the European food industry, 
while ensuring the safety of food, main taining high level of public health 
protection and taking global as pects into consideration.   
EN 5   EN 2. C ONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT  
• Consultation of interested parties 
 Consultation methods, main secto rs targeted and general profile of 
respondents  
 There was a broad consultation of all in terested parties seek ing their views on 
the provisions and application of existin g legislation and the need for change. 
The respondents were the competent aut horities of the Member States, industry 
association representatives and consumer organisations. 
 Summary of responses and how th ey have been taken into account  
– Consumer organisations main concer n is that certain foods are unduly 
covered by special designation/st atus under the current Framework 
Directive which could put them out of the scope of other important 
provisions – e.g. Regulation on Nutr ition and Health Claims. These 
stakeholders have highlighted that where there are no compositional or labelling requirements justified by specific nutritional needs and 
consumer protection there is no need to grant a special status to foods. This is especially the case when th is status allows the food to bear a 
suitability statement that could be c onfused with a nutrition or health 
claim or make the food appear more  appropriate than a similar normal 
food. 
– The specialised 'dietetic food' industr y believes that clear and transparent 
legislation governing the composition of products for the dietetic food 
sector is essential to maintain the protection of vulnera ble groups of the 
population and those with special nutr itional needs from a public health 
and food safety perspectiv e. In that context, th ey suggest to strengthen 
the current legislation and to incl ude in a positive list at least the 
following groups of products: 'Foods for infants and young children up to the age of three - including Low Bi rth Weight Formula'; 'Hospital 
Discharge Formula'; 'Breast Milk Fortifier and Growing Up Milks'; 
'Foods for pregnant and lactating wo men'; 'Foods for the elderly in good 
health'; ‘Foods for weight management’; ‘Foods for special medical purposes’; ‘Foods for sportspeople’;  ‘Dietary foods for people with 
gluten intolerance’; ‘Lactose-free foods’. 
 In addition, the dietetic food in dustry emphasises the need for a 
transparent, efficient and effective procedure for the expansion of the Union list. They argue that science still emerges in this area and therefore a flexible procedure must be offered to promote innovation. 
 Nevertheless, this position is not sh ared by all parts of the industry; 
certain others believe that the same rules should apply to all foods and 
that there is no reason to foresee di fferent rules except in very limited 
cases, where nutritional food safety issues are concerned. For certain categories of foods, additional rules may result in unnecessary burden on  
EN 6   EN the industry. In addition, they fear th at a legal straight jacket may hamper 
innovation. 
– Member States have reported that th e legislation on dietetic foods is 
being used by some operators to circum vent the rules of subsequent food 
legislation such as the Regulation on claims, distorting the notion of a 
food for particular nutritional uses, and resulting, in certain cases, in confusion over its application that creates unfair competition between 
businesses and difficulties for enforcement.  
 Member States underline that the mo st important aspect to maintain 
would be consumer safety.  
 The Commission identified in it s impact assessment supporting the 
proposal four options taking into account the aforementioned issues and compared them in light of the objec tives of the revision (coherence, 
simplification, harmonisation and small businesses and innovation). 
• Collection and use of expertise 
 There was no need for external expertise. 
• Impact assessment  
 The Commission carried out an impact assessment which is presented in 
parallel to this proposal as a Commission Staff Wo rking Paper.  
 Four different options have been considered ranging from repealing the 
legislation to establishing a reinforced  legislation for dietetic foods. These 
options were assessed taking into account their economic, social and 
environmental impacts on the various stakeholders and authorities. In addition, a no-change scenario was considered as a reference against which to assess the possible impacts of th e different options.  
 Two different approaches have been considered:  
(1) the notion of dietetic food is no l onger needed to help the food market 
today and should be abolished; 
(2) the notion of dietetic food needs to be strengthened to bring it more into 
line with today's food market and consumers' needs.  
 The four options (two following approach (1) and two following approach (2)) 
considered within the Impact Assessment have been developed to ensure that 
none of them would result in the removal of products from the market but they 
may necessitate potential label changes and/or reformulation of products or 
have an impact on their market value. In other words, the options considered 
for the revision of the dietetic food legislation do not foresee any ban per se  of 
foods currently sold as f oods for particular nutriti onal uses. In addition, the 
proposed rules within each option woul d allow for market adaptation and 
therefore a sufficient transitional period is foreseen to help have a smooth 
transition to the new legislati on and minimise economic burden.  
EN 7   EN  Summary of the options and the key impacts under each of them: 
• Option 1 – Repeal all the le gislation on dietetic foods  (Framework Directive 
and all the specific Directives adopted under that Framework) 
 Repealing the concept of dietetic food will prevent further distortions between 
'dietetic' foods with suitability statemen ts and 'normal' foods with nutrition and 
health claims. However, whilst such an option appears to be a good one in 
terms of simplification and reducing ad ministrative burden, the trade off in 
terms of the introduction of national legi slation to compensate the repeal of 
certain Union legislation (e.g. on foods intended for infants and young 
children) may be significant.  
• Option 2 – Repeal the Framework Direct ive on dietetic foods but maintain 
certain of the specific rules adopted under that Framework  
 This option provides the same simplif ication and administrative burden 
reduction benefits as option 1 but also gives the Union the possibility to maintain for certain cate gories of foods, rules the harmonisation of which has 
provided added value at EU level. Ha ving no general rules on dietetic foods 
anymore and clearer rules for certain specific produc ts should ensure better 
coordination between the requirements of  different pieces of legislation.  
• Option 3 – Revision of the Framework Directive establishing  a positive list 
of dietetic foods with specific co mpositional and/or labelling rules  
 The main advantage of setting a positiv e list for dietetic foods with specific 
compositional and labelling rules is that standardised rules would apply to the 
dietetic food sector ensuring harmoni sation across the European Union. 
However, the burden that would fall on the industry and Member States for having to comply with additional specific di etetic food legislation to be able to 
target food to certain groups of the population may be considered 
disproportionate particularly taking in to account the minimal additional public 
health and consumer information benefits.  
• Option 4 – Amending the Framework Directive replacing the notification 
procedure with a centralised Union prior-authorisation procedure based 
on a scientific assessment  
 The application of a standard prior-aut horisation procedure would ensure more 
harmonisation across the European Un ion than the general notification 
procedure currently in place. However, th e burden of prior authorisation before 
using a 'dietetic' suitability statement on a product seems to be disproportionate in terms of consumers' protection and in formation and would be highly costly 
for the industry and especially for SMEs. 
 The Commission proposal follows option 2 - Repeal the Framework Directive 
on dietetic foods but maintain certain of  the specific rule s adopted under that 
Framework.  
EN 8   EN 3. L EGAL ELEMENTS OF THE PROPOSAL  
• Summary of the proposed action 
 Adoption of a Regulation of the Eur opean Parliament and of the Council 
establishing rules applicable to f oods intended for infants and young children 
and to foods for special medical pur poses and concerning a Union list of 
substances which can be added to the foods covered by this proposal.  
 The proposal simplifies a nd clarifies legal requireme nts applying to certain 
categories of foods and establishes a single list of substances that may be added 
to the foods ('Union list') covered by this proposal. In particular, it: 
– provides a new general Framework le gislation applying to well-defined 
categories of foods that have been id entified as essential for certain well-
established groups of consumers w ith specific nutritional needs; 
– establishes a clear and defi ned scope of application; 
– maintains specific measures for categories of foods that are essential for 
certain groups of the population; 
– lays down general rules as regards the composition and labelling 
applying to these categories of foods; 
– removes differences in interpretation and difficulties for Member States 
and operators in applying different  pieces of food legislation by 
simplifying the regulatory environment;  
– removes the burdens associated w ith the notification procedure; 
– ensures that similar products are treated in the same way across the 
Union;  
– removes rules that have become  unnecessary, contradictory and 
potentially conflicting; 
– establishes a single legal measure for s ubstances that can be added to the 
foods covered by this proposal; 
 The new proposal will repeal Dir ective 92/52/EC, Di rective 2009/39/EC, 
Directive 96/8/EC and Regulation (EC) No 41/2009.  
 The specific compositional and informati on requirements will be laid down in 
delegated Regulations, adopted by th e Commission, in accordance with 
Article 290 of the Treaty on the Functioning of the European Union (TFEU) 
taking into account the gene ral requirements laid down in this proposal as well 
as Commission Directives 2006/141 /EC, 2006/125/EC, and 1999/21/EC.  
 The adoption of the Union list implies the application of criteri a set out in this 
proposal therefore implementing powers shall be conferred on the Commission  
EN 9   EN in that respect. Those powers shall be exercised in accordance with Regulation 
(EU) No 182/2011. 
 Emergency procedures are foreseen in situations where food covered by this 
proposal constitutes a serious risk to  human health. For this purpose, 
implementing powers shall be conferred on the Commission in that respect. 
Those powers shall be exercised in accordance with Regulation (EU) No 
182/2011 of the TFEU. 
• Legal basis 
 This proposal is based on Article 114 TFEU. This lega l basis is justified both 
by the objective and the content of th e proposal. Measures adopted under 
Article 114 TFEU should have as their object the establishment and 
functioning of the internal market. The proposal establishes a harmonised legal 
framework concerning the composition a nd information requirements for infant 
formulae and follow-on formulae, proce ssed cereal-based foods and baby foods 
for infants and young children and foods for special medical purposes as well as a Union list of substances that can  be added to such foods since it is 
necessary to keep a harmonized framewor k for products addressed to particular 
vulnerable parts of the population for wh ich categories of food constitute the 
sole source of nourishment. The object ive of the proposal is to avoid any 
differences between national laws relati ng to the categories of food at issue 
impeding their free movement and t hus having a direct impact on the 
establishment and functioning of the internal market.  
• Subsidiarity principle 
 The subsidiarity principle applies inso far as the proposal does not fall under the 
exclusive competence of the Union. 
 The objectives of the proposal cannot be  sufficiently achieved by the Member 
States for the following reason(s): 
 Prior to the adoption of the Framework Di rective, the national measures in the 
Member States differed from one Member State to another. The differences between these laws obliged the dietetic  food industry to vary their production 
according to the Member State for which the products were intended. To respond to this, general rules and a numb er of specific measures have been 
adopted at Union level. 
 In order to harmonise intra-union trade and trade with third countries the Union 
does have the right to act. However, this should be balanced against the 
proportionality of the measure and the added value Union rules will have for 
citizens across all Member States.  
 Individual action by Member States could lead to differi ng levels of food safety 
and protection of human health and conf use consumers. In addition, it would 
endanger the free movement of  these foods in the Union.  
EN 10   EN  The core of the Union action would main tain existing rules for certain products 
that are traded widely within the Un ion and where there is agreement amongst 
Member States for the continuing need for specific composition and labelling 
rules to ensure the free movement of th ese goods. It also ai ms to simplify the 
regulatory environment as regards the addition of substan ces to the foods 
covered by this proposal. 
 The proposal therefore complies wi th the subsidiarity principle. 
• Proportionality principle 
 The proposal complies with the propor tionality principle for the following 
reason(s): 
 The proposal harmonises the regulat ory framework establishing general 
provisions applying to certain categories of foods where the need for additional 
compositional and labelling provisions to the general rules applying to all 
foods is demonstrated. Such additiona l provisions contribute to consumer 
protection by ensuring that consumers re ceive nutritionally adequate foods and 
appropriate information.  
 The proposed measures are sufficient in  terms of reaching the objectives of 
ensuring that consumers make informed  and safe choices and securing the 
smooth functioning of the inte rnal market. At the same time they do not impose 
an excessive or unjustified burden. 
 The absence of harmonisation for these ca tegories of foods would result in a 
proliferation of national rules resulti ng in different levels of consumer 
protection between the Member States and increased burden for the industry.  
 The financial burden is minimised as the current specific  provisions exist 
already, the general provisions are only simplified and clarified as to their 
scope of application. 
• Choice of instruments  
 Proposed instruments: Regulation. 
 Other type of measure would not be adequate for the following reason(s). 
 The existing framework is, in general, prescriptive with little flexibility for 
Member States in how it should be app lied. A Directive would have lead to an 
inconsistent approach in the Union l eading to uncertainty for both consumers 
and the industry. A Regulati on provides a consistent ap proach for industry to 
follow and reduces the administrative burden as operators do not need to 
familiarise themselves with the indivi dual national legislation in the Member 
States. 
 Soft law instruments such as guidelin es would be a flexible approach to 
addressing certain changes needed in the current legislation bu t not all of them. 
In addition, due to the non-binding status such instruments are considered not  
EN 11   EN sufficient to tackle differences in the interpretation and implementation of the 
legislation.  
4. B UDGETARY IMPLICATION  
None. 
5. A DDITIONAL INFORMATION  
• Simulation, pilot phase and transitory period 
 There will be a transitory period for the application of the proposal.  
• Simplification 
 The proposal provides for simplification of  legislation. This is one of the main 
objectives of the revision of the legisl ation on foods for particular nutritional 
uses.  
 The use of a Regulation as the legal instrument supports the objective of 
simplification because it guarantees that all actors have to follow the same rules at the same time. 
 National administrative procedures following the implementation of the 
general notification procedure will be abolished reducing the administrative 
burden associated with the impl ementation of the legislation. 
 The provisions adopted in and under Directive 2009/39/EC that have become 
unnecessary, contradictory and potentia lly conflicting will be removed.  
 The proposal is included in the Co mmission Working Pr ogramme for 2011 – 
Annex III – Simplification Rolling Pr ogramme and Administrative Burden 
Reduction initiatives under the reference 2009/SANCO/004. 
• Repeal of existing legislation 
 The adoption of the proposal will lead to the repeal of existing legislation. 
• Recasting 
 The proposal involves recasting. 
• European Economic Area 
 The proposed act concerns an EEA matter and should therefore extend to the 
European Economic Area. 
• Detailed explanation of the proposal 
 The Regulation provides the basis for the assurance of a high level of consumer 
protection in relation to foods intended  for infants and you ng children and to  
EN 12   EN foods for special medical purposes. It establishes also a single legal measure 
that regulates the list of substances th at can be added to the foods covered by 
the proposal (Chapter I). 
 Chapters II and III provide for general principles and specific provisions that 
shall apply to infant formulae and follow-on formulae, processed cereal-based foods and baby foods for infants and young children and foods for special medical purposes. 
 Chapter IV relates to the establishment of  a Union list of substances that can be 
added to the foods covered by the propos al and provides for a procedure for 
updating the Union list. 
 Chapter V provides for a general confidentiality clause.  Chapter VI and VII concerns all the procedural provisions related to the 
implementation of the new proposal, the delegation of powers, the procedures, 
the necessary amendments and the measures that are to be repealed. It specifies 
also the transitional measures that w ould apply to the categories of foods 
currently regulated under Di rective 2009/39/EC and the da te of entry into force 
and application.  
EN 13   EN 2011/0156 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on food intended for infants and young ch ildren and on food for special medical 
purposes  
(presented by the Commission pursuant to Arti cle 114 of the Treaty on the Functioning 
of the European Union) 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114  thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee, 
Acting in accordance with the or dinary legislative procedure
1, 
Whereas: (1) Article 114 of the Treaty on the Functioning of the European Union (TFEU) provides 
that measures having as their object the es tablishment and functioning of the internal 
market and which concern inter alia  health, safety and consumer protection must 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 internal 
market and contributes signifi cantly to the health and well -being of citizens, and to 
their social and economic interests. 
(3) Directive 2009/39/EC of the European Par liament and of the Council of 6 May 2009 
on foodstuffs intended for particular nutritional uses
2 lays down general rules on the 
composition and preparation of such foods that are specially designed to meet the 
particular nutritional requirements of th e persons to whom they are intended. The 
                                                 
1 Position of the European Parliament  of … and position of the Council at first reading of ... Position of 
the European Parliament of ... an d decision of the Council of .... 
2 OJ L 124, 20.5.2009, p. 21.  
EN 14   EN majority of the provisions laid down in that  Directive date back  to 1977 and should 
therefore be reviewed. 
(4) Directive 2009/39/EC establishes a common definition for 'foodstuffs for particular 
nutritional uses' and general labelling requir ements, including that  such foods should 
bear an indication of their suitability  for the claimed nutritional purposes.  
(5) The general composition and labelling re quirements laid down in Directive 
2009/39/EC are complemented by a number of  non-legislative Union acts, which are 
applicable to specific categories of food. In that respect, Commission Directive 
2006/141/EC of 22 December 2006 lays down harm onised rules with re spect to infant 
formulae and follow-on formulae3, whereas Commission Directive 2006/125/EC of 
5 December 2006 lays down certain harmonised rules with respect to  processed cereal-
based foods and baby foods for infants and young children4. Similarly, harmonised 
rules are also laid down by Commission Directive 96/8/EC of 26 February 1996 on 
foods intended for use in energy-re stricted diets fo r weight reduction5, Commission 
Directive 1999/21/EC of 25 March 1999 on  dietary foods for special medical 
purposes6 and Commission Regulation (EC)  No 41/2009 of 20 January 2009 
concerning the composition and labelling of  foodstuffs suitable people intolerant to 
gluten7. 
(6) In addition, Council Directiv e 92/52/EEC of 18 June 1992 lays down harmonised rules 
with respect to infant formulae and follow-on formulae intended for export to third countries
8. 
(7) Directive 2009/39/EC foresees that specific provisions could be adopted regarding the 
two following specific categories of food falli ng within the definition of foodstuffs for 
particular nutritional uses: 'food intended to meet the expenditure of intense muscular 
effort, especially for sportsmen' and 'f ood for persons suffering from carbohydrate 
metabolism disorders (diabetes)'. With regard  to food intended to meet the expenditure 
of intense muscular effort, no successful conclusion could be re ached as regard the 
development of specific provisions due to  widely diverging views among Member 
States and stakeholders concerning the scope of the specific legislation, the number of 
sub-categories of the food to be included, the criteria for establishing composition 
requirements and the potential impact on innovation in product development. As 
regards special provisions for food for persons suffering from carbohydrate 
metabolism disorders (diabe tes), a Commission report9 concludes that the scientific 
basis for setting specific compositional requirements is lacking.  
(8) Directive 2009/39/EC also requ ires a general notification procedure at national level 
for food presented by food business operato rs as falling under the definition of 
'foodstuffs for particular nutri tional uses' and for which no specific provisions are laid 
                                                 
3 OJ L 401, 30.12.2006. p. 1.  
4 OJ L 339, 6.12.2006, p. 16. 
5 OJ L 55, 6.3.1996, p. 22. 
6 OJ L 91,7.4.1999, p. 29.  
7 OJ L 16, 21.1.2009, p. 3. 
8 OJ L 179, 1.7.1992, p. 129. 
9 COM (2008) 392 Report from the Commission to the European Parliament and the Council on foods 
for persons suffering from carbohydrate metabolism disorders (diabetes), Brussels, 26.6.2008.  
EN 15   EN down in Union law, prior to their placing on the Union market, in order to facilitate the 
efficient monitoring of such food by the Member States.  
(9) A report from the Commission to the Eur opean Parliament and the Council on the 
implementation of that notification procedure10 showed that difficulties may arise from 
different interpretations of the definition of  foodstuffs for particul ar nutritional uses 
which appeared to be open to different in terpretations by the na tional authorities. It 
therefore concluded that a revision of the scope of Di rective 2009/39/EC would be 
required to ensure a more effective a nd harmonised implementation of the Union 
legislation.  
(10) A study report11concerning the revision of the legisl ation on foodstuffs  for particular 
nutritional uses confirms the findings of the Commission report on the implementation 
of the notification procedure and indicates that an increa sing number of foodstuffs are 
today marketed and labelled as foodstuffs su itable for particular nutritional uses, due 
to the broad definition laid down in Directive 2009/39/EC. The study report also points out that the type of food regulated under that le gislation differs  significantly 
between Member States; similar food could at the same time be marketed in different 
Member States as food for particular nut ritional uses and/or as food for normal 
consumption addressed to the population in general or to certain sub-groups thereof 
such as pregnant women, postmenopausal women, older adults, growing children, 
adolescents, variably active individuals and others. This st ate of affairs undermines the 
functioning of the intern al market, creates legal uncertain ty for competent authorities, 
food business operators and consumers, wh ile the risks of ma rketing abuse and 
distortion of competition cannot be ruled out.  
(11) It appears that other Union acts recently a dopted are more adapted to an evolving and 
innovative food market than Directive 2009/39/EC. Of particul ar relevance and 
importance in that respect are: Directive 2002/46/EC of the European Parliament and 
the Council of 10 June on the approximation of  the laws of the Member States relating 
to food supplements
12, Regulation (EC) No 1924/2006 of the European Parliament and 
the Council of 20 Decembe r 2006 on nutrition and health claims made on foods13 and 
Regulation (EC) No 1925/2006 of the Europe an Parliament and the Council of 20 
December 2006 on the addition of vitamins and minerals and other substances to 
foods14. Furthermore, the provisions of these Union acts would adequately regulate a 
number of the categories of food c overed by Directive 2009/39/EC with less 
administrative burden and more clarity as to the scope and objectives.  
(12) Moreover, experience sh ows that certain rules included in or adopted under Directive 
2009/39/EC are no longer effective to ensure the functioning of the internal market.  
                                                 
10 Report from the Commission to the European Parliament and the Council on the implementation of 
Article 9 of Council Directive 89/398/EEC on the approximation of the laws of the member States 
relating to foodstuffs intended for particular  nutritional uses, COM (2008)393, dated 27.6.2008. 
11 An analysis of the European, soci al and environmental impact of the policy options for the revision of 
the Framework Directive on dietetic foods – Study  report Agra CEAS Consulting, dated 29.4.2009.. 
12 OJ L 183, 12.7.2002, p. 51. 
13 OJ L 404, 30.12.2006, p. 9. 
14 OJ L 404, 30.12.2006, p. 26.  
EN 16   EN (13) Therefore, the concept of “foodstuffs fo r particular nutritional uses” should be 
abolished and Directive 2009/39/EC should be replaced by the present act. To simplify 
its application and to ensure  consistency throughout the Me mber States, the present act 
should take the form of a Regulation. 
(14) Regulation (EC) No 178/2002 of the Europe an Parliament and of the Council of 
28 January 2002 laying down th e general principles and requirements of food law, 
establishing the European Food Safety Authority and laying down procedures in 
matters of food safety15 establishes common principles and definitions for Union food 
law in order to ensure a high level of heal th protection and the effective functioning of 
the internal market.  It establishes the principles of risk analysis in relation to food and 
establishes the structures and mechanisms fo r the scientific and technical evaluations 
which are undertaken by the European Food Sa fety Authority (herei nafter referred to 
as 'the Authority'). Therefore, certain defi nitions laid down in that Regulation must 
also apply in the context of the present Re gulation. Moreover, for the purpose of this 
Regulation, the Authority should be consulte d on all matters likely to affect public 
health.  
(15) A limited number of categories of food cons titutes the sole sour ce of nourishment of 
certain groups of the population or repr esent a partial source of nourishment; such 
categories of food are vital for the manage ment of certain conditions and/or are 
essential to maintain the intended nutriti onal adequacy for certa in well-established 
vulnerable groups of the population. Those ca tegories of food include infant formulae 
and follow-on formulae, processed cerea l-based food and baby food and food for 
special medical purposes. Experience has shown that the provisions laid down in 
Commission Directive 2006/ 141/EC, Commission Directive 2006/125/EC, as well as 
Commission Directive 1999/21/EC ensure th e free movement of such food in a 
satisfactory manner, while ensuring a high le vel of protection of public health. It is 
therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formul a and follow-on formulae, processed cereal-
based food and baby food for infants and young children and to  food for special 
medical purposes, taking into acc ount Commission Directive 2006/141/EC, 
Commission Directive 2006/125/EC a nd Commission Directive 1999/21/EC. 
(16) To ensure legal certainty, definitions  laid down in Commission Directive 
2006/141/EC, Commission Directive 2006/ 125/EC and Commission Directive 
1999/21/EC should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes should be regularly adapted taking into account 
technical and scientific progress and relevant  developments at international level, as 
appropriate. 
(17) It is important that ingredients used in the manufacture of the categories of food 
covered by this Regulation ar e appropriate to satisfy the nutritional requirements of, 
and are suitable for the persons to whom th ey are intended and that their nutritional 
adequacy has been established by generally accepted scientific data. Such adequacy 
should be demonstrated through a systematic re view of the availabl e scientific data.  
                                                
 
15 OJ L 31, 1.2.2002, p. 1.   
EN 17   EN (18) General labelling requirements are laid down in Directive 2000/13/EC of the European 
Parliament and of the Council of 20 Marc h 2000 on the approximation of the law of 
the Member States relating to labelling, presentation a nd advertising of foodstuffs16. 
Those general labelling requirements should, as  a general rule, apply to the categories 
of food covered by this Regulation. However,  this Regulation should also provide for 
additional requirements to, or derogations from, the provisions of Directive 
2000/13/EC, where necessary, in order to m eet the specific obj ectives of this 
Regulation.  
(19) This Regulation should provide the criteria for the establishment of the specific 
compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby f ood, and food for special medical purposes, 
taking into account Commission Direct ive 2006/141/EC, Commission Directive 
2006/125/EC and Commission Directive 1999/21/EC . In order to adapt the definitions 
of infant formula, follow-on formula, pr ocessed cereal-based food and baby food, and 
food for special medical purposes  laid down in this Regulation taking into account 
technical and scientific  progress and relevant developmen ts at international level, to 
lay down the specific compositional and inform ation requirements with respect to the 
categories of food covered by this Regulat ion, including for additional labelling 
requirements to, or derogations from, the provisions of Directive 2000/13/EC and for 
the authorisation of nutr ition and health claims,  the power to adopt acts in accordance 
with Article 290 of the Treaty on the Func tioning of the European Union should be 
delegated to the Commission. It is of particular impor tance that the Commission 
carries out appropriate consu ltations during its preparatory work, including at expert 
level. The Commission, when preparing and drawing-up delegated acts, should ensure 
a simultaneous, timely and appropriate tran smission of relevant documents to the 
European Parliament and Council.  
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids 
and other substances that may be added to infant formula, follow-on formula, 
processed cereal-based food and baby f ood, and food for special medical purposes, 
subject to certain criteria laid down in this  Regulation. Given the fact that the adoption 
of the list implies the applica tion of criteria set out in this Regulation, implementing 
powers should be conferred on the Commission in that re spect. Those powers should 
be exercised in accordance with Regula tion (EU) No 182/2011 of the European 
Parliament and of the Council of 16 Februa ry 2011 laying down the rules and general 
principles concerning mechanisms for cont rol by Member States of the Commission's 
exercise of implementing powers
17. The Commission should adopt immediately 
applicable implementing acts updating the Uni on list, where, in duly justified cases 
relating to public health, imperativ e grounds of urgency so require.  
(21) At present, pursuant to the Opinion of  the Scientific Committee on Emerging and 
Newly Identified Health Risks (SCENIHR)18 on the risk assessment of products of 
nanotechnologies, dated 19 January 2009 , there is inadequate information on the risks 
associated with engineered nanomaterials  and existing test methods may not be 
                                                 
16 OJ L 184, 17.7.1999, p. 23. 
17 OJ L 55, 28.2.2011, p. 13. 
18 Scientific Committee established by Commission D ecision of 5 August 2008 setting up an advisory 
structure of Scientific Committees and experts in th e field of consumer safety, public health and the 
environment and repealing Decision 2004/210/EC (2008/721/EC), OJ L 241, 10.9.2008, p. 21.  
EN 18   EN sufficient to address all of the issues arising in relation to engineered nanomaterials. 
Therefore, engineered nanomaterials should not be included in the Union list for the 
categories of food covered by this Regulati on, until an evaluation by the Authority is 
carried out.  
(22) In the interests of efficiency and legislat ive simplification, there should be a medium-
term examination of the question whether to extend the scope of th e Union list to other 
categories of food governed by other specific Union legislation .  
(23) It is necessary to establish procedures for the adoption of emergency measures in 
situations where food covered by this Regulat ion constitutes a seri ous risk to human 
health. In order to ensure uniform condi tions for the implementation of emergency 
measures, implementing powers should be  conferred on th e Commission. Those 
powers should be exercised in accord ance with Regulation (EU) No 182/2011. The 
Commission should adopt immediately app licable implementing acts relating to 
emergency measures, where, in duly jus tified cases relating to public health, 
imperative grounds of urgency so require. 
(24) Council Directive 92/52/EEC states that  infant formulae and follow-on formulae 
exported or re-exported from the European Union have to comp ly with Union law 
unless otherwise required by the importing co untry. This principl e has already been 
established for food in Regul ation (EC) No 178/2002. For th e sake of simplification 
and legal certainty, Dire ctive 92/52/EEC should th erefore be repealed.  
(25) Regulation (EC) No 1924/2006 of the Europe an Parliament and of the Council of 
20 December 2006 on nutrition and h ealth claims made on foods19 establishes the 
rules and conditions for the use of nutriti on and health claims on food. Those rules 
should apply as a general rule  to the categories of food c overed by this Regulation, 
unless otherwise specified in this Regulati on or non-legislative acts adopted pursuant 
to this Regulation. 
(26) Currently, the statements 'gluten-free' a nd 'very low gluten' may be used for food 
intended for particular nutritional uses and for food for normal consumption under the 
rules specified in Commission Regula tion (EC) No 41/2009 concerning the 
composition and labelling of foodstuffs suitable for people intolerant to gluten20. Such 
statements could be construed as nutrition claims, as defined in Regulation (EC) No 
1924/2006. For the sake of simplification, those statements should be regulated solely 
by Regulation (EC) No 1924/2006 and comply  with requirements therein. It is 
necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, 
incorporating the nutrition claims 'glute n-free' and 'very low gluten' and their 
associated conditions of use as regul ated under Regulation (EC) No 41/2009 be 
completed prior to the entry into application of this Regulation.  
(27) 'Meal replacement for weight control' and 't otal diet replacement for weight control' 
are considered as food for par ticular nutritional uses and ar e governed by specific rules 
adopted under Directive 96/8/EC. However,  more and more food intended for the 
general population has appeared on the market  carrying similar declarations which are 
                                                 
19 OJ L 404, 30.12.2006, p. 9. 
20 OJ L 14, 20.1.2009, p. 5.  
EN 19   EN presented as health claims for weight cont rol. In order to eliminate any potential 
confusion between food marketed for weight  control and in the interests of legal 
certainty and coherence of Union legisla tion, such statements should be regulated 
solely by Regulation (EC) No 1924/2006 and co mply with requirements therein. It is 
necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, 
incorporating the health  claims referring to the body we ight control for food presented 
as 'total diet replacement for weight cont rol' and as 'meal replacement for weight 
control' and associated conditions of us e as regulated under Directive 96/8/EC be 
completed prior to the entry into application of this Regulation.  
(28) Since the objectives of the actions to be  taken cannot be sufficiently achieved by the 
Member States and can therefore be bette r achieved at Union level, the Union may 
adopt measures, in accordance with the principl e of subsidiarity as set out in Article 5 
of the Treaty on European Union. In accordan ce with the principl e of proportionality, 
as set out in that Ar ticle, this Regulation does not go beyond what is  necessary in order 
to achieve those objectives. 
(29) Adequate transitional measures are necessa ry to enable food bus iness operators to 
adapt to the requirements of this Regulation.  
HAVE ADOPTED THIS REGULATION: 
CHAPTER I 
SUBJECT MATTER AND DEFINITIONS 
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 for infants and young children; 
(c) food for special medical purposes. 
2. This Regulation provides the rules for th e establishment and update of a Union list 
of. vitamins, minerals and other substances that can be added to the categories of 
food referred to in paragraph 1. 
Article 2 
Definitions 
1. For the purposes of this Regulation, th e following definitions shall apply:  
(a) the definitions of 'food ' and 'placing on the market' set out in Articles 2 and 
3(8) of Regulation (EC) No 178/2002;  
EN 20   EN (b) the definitions of 'labelling' and 'pre-p ackaged foodstuff' in points (a) and (b) of 
Article 1(3) of Directive 2000/13/EC; 
(c) the definitions of 'nutrition claim' and 'health claim' set out in points (4) and (5) 
of Article 2(2) of Regulation (EC) No 1924/2006; and,  
(d) the definition of 'other substance' set out in Article 2(2) of Regulation (EC) No 
1925/2006. 
2. The following definitions shall also apply: 
(a) ‘Authority’ means the European Food Safety Authority established by 
Regulation (EC) No 178/2002; 
(b) ‘infants’ means children  under the age of 12 months; 
(c) ‘young children' means children between one and three years; 
(d) 'infant formula' means food used by in fants during the first months of life and 
satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding; 
(e) 'follow-on formula' means food used by infants when appropriate 
complementary feeding is introduced and constituting the principal liquid 
element in a progressively diversified diet of such infants; 
(f) 'processed cereal-based food' means food  
(i) intended to fulfil the particular re quirements 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 fo r their progressive adaptation to 
ordinary food and 
(ii) pertaining to the fo llowing four categories: 
– simple cereals which are or have to be reconstituted with milk or 
other appropriate nutritious liquids; 
– cereals with an added high protei n food which are or have to be 
reconstituted with water or other protein-free liquid; 
– 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; 
(g) '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 thei r progressive adaptation to 
ordinary food, excluding:  
EN 21   EN (i) processed cereal-based food and 
(ii) milk intended for young children; 
(h) 'food for special medical purposes'  means food intended for the dietary 
management of patients 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, metabolis e or excrete ordinary food or certain 
nutrients contained ther ein, or with other medi cally-determined nutrient 
requirements, whose dietary management cannot be achieved only by modification of the normal diet. 
3. The Commission shall be empowered to a dopt delegated acts in  accordance with 
Article 15 to adapt the definitions of 'inf ant formula', 'follow-on formula', 'processed 
cereal-based food' and 'baby food' and 'food for special me dical purposes' taking into 
account technical and scientific  progress and relevant deve lopments at international 
level, as appropriate.  
CHAPTER II 
PLACING ON THE MARKET  
Article 3 
Placing on the market   
Food referred to in Article 1(1) may be placed  on the market only if it complies with the 
provisions of this Regulation.  
Article 4  
Pre-packaged food  
Food referred to in Article 1(1) shall only be al lowed on the retail market in the form of pre-
packaged food. 
Article 5 
Free movement of goods 
Member States may not, for reasons related to their composition, manufacturing, presentation 
or labelling, restrict or forbid the placing on the market  of food which complies with this 
Regulation. 
Article 6 
Emergency measures  
1. Where it is evident that a food referred to in Article 1(1) is likely to constitute a 
serious risk to human health and that such  risk cannot be contained satisfactorily by 
means of measures taken by the Member St ate(s) concerned, the Commission on its 
own initiative or at the request of a Memb er State, shall without delay take any 
appropriate interim emergency measures , including measures restricting or 
prohibiting the placing on the market of the food concerned, depending on the 
gravity of the situation. T hose measures shall be adopt ed by means of implementing 
acts in accordance with the examination pro cedure referred to in Article 14(2).   
EN 22   EN 2. On duly justified imperative grounds of extr eme urgency to contain and/or address a 
serious risk to human health, the Commi ssion shall adopt immediately applicable 
implementing acts in accordance with the pr ocedure referred to  in Article 14(3).  
3. Where a Member State officially inform s the Commission of the need to take 
emergency measures and the Commission has not acted in accordance with paragraph 1, the Member State concerne d may adopt any appropriate interim 
emergency measures, restricti ng or prohibiting the placing on  the market of the food 
concerned, depending on the gravity of the situation, within its territory. It shall 
immediately inform the other Member Stat es and the Commission thereof, giving the 
grounds for its decision. The Commission sh all adopt implementing acts aiming at 
extending, amending or abrogating the nati onal interim emergency measures. Those 
implementing acts shall be adopted in acc ordance with the ex amination procedure 
referred to in Article 14(2). The Member State may maintain its national interim emergency measures until the implementing acts mentioned in this paragraph have been adopted.  
CHAPTER III 
REQUIREMENTS  
 
SECTION 1 
INTRODUCTORY PROVISIONS  
Article 7 
Introductory provisions   
1. Food referred to in Article 1(1) shall comply with any requirement of Union law 
applicable to food. 
2. The requirements laid down in this Regulation shall prev ail over any other 
conflicting requirement of Union law applicable to food.  
Article 8 
Opinions of the Authority  
The European Food Safety Authority shall provid e scientific opinions in accordance with 
Articles 22 and 23 of Regulation (EC) No 178/ 2002 for the purpose of application of the 
present Regulation. 
SECTION 2 
GENERAL REQUIREMENTS  
Article 9 
General composition and information requirements  
1. The composition of food referred to in Article 1(1) shall be such that it is appropriate 
to satisfy the nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with genera lly accepted scientific data.   
EN 23   EN 2. Food referred to in Article 1( 1) shall not contain any substance in such quantity as to 
endanger the health of the persons  to whom they are intended. 
3. The labelling, presentation a nd advertising of food referred to in Article 1(1) shall 
provide adequate consumer informa tion and must not be misleading.  
4. The dissemination of any useful informati on or recommendations with reference to 
the categories of food referred to in Ar ticle 1 (1) may be made exclusively by 
persons having qualifications in medicine, nutrition, pharmacy or other professionals 
responsible for maternal and child health care.  
SECTION 3 
SPECIFIC REQUIREMENTS  
Article 10 
Specific composition and information requirements  
1. Food referred to in Article 1(1) must comp ly with the requirements of Article 7 and 
composition and information requirements provided in Article 9. 
2. Subject to the general requirements of Articles 7 and 9 and taking into account 
Directive 2006/141/EC, Directive 2006/125/EC  and Directive 1999/21/EC as well as 
any technical and scientific progress, th e Commission shall be empowered to adopt 
delegated Regulati ons, no later than [2 years after the date of the entry into force of 
this Regulation],  in accordance with Article 15, w ith respect to the following: 
(a) the specific compositional requirements  of food referred to  in Article 1(1); 
(b) the specific requirements on the use of  pesticides in agricultural products 
intended for the production of such food and on pesticides residues in such 
food;  
(c) the specific requirements on labelling, presentation and advertising of food 
referred to in Article 1(1), including th e authorisation of nutrition and health 
claims thereof; 
(d) the notification procedure for the placi ng on the market of a food referred to in 
Article 1(1) in order to facilitate the e fficient official monitoring of such food 
on the basis of which food operators sha ll notify the competent authority of the 
Member State(s) where the product is being marketed; 
(e) the requirements on promotional and commercial practices relating to infant 
formulae; and,  
(f) the requirements on information to be provided on infant and young child 
feeding in order to ensure adequate  information on appropriate feeding 
practices. 
3. Subject to the requirements of Articles 7 and 9 and taking in to account relevant 
technical and scientific progress, the Commission sh all update the delegated 
Regulations mentioned in paragra ph 2 in accordance with Article 15.   
EN 24   EN Where in the case of emerging health ri sks, imperative grounds of urgency so 
require, the procedure provided in Article 16 shall apply to delegated acts adopted 
pursuant to this paragraph.  
CHAPTER IV 
UNION LIST OF PERMITTED SUBSTANCES 
Article 11 
Union list of permitted substances  
1. Vitamins, minerals, amino acids and other substances may be added to food referred 
to in Article 1(1), provided that such substances meet the following conditions:  
(a) they do not, on the basis of the scie ntific evidence available, pose a safety 
concern to the health of the consumer; and, 
(b) they are available for use by the human body. 
2. No later than [2 years after the date of the entry into force of this Regulation], the 
Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulations. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the 
applicable purity criteria. Those impleme nting Regulations shall be adopted in 
accordance with the examination procedure referred to in Article 14(2). On duly 
justified grounds of extreme urgency relating to emerging health risks , the 
Commission shall adopt immediately appl icable implementing acts updating the 
Union list in accordance with Article 14(3). 
3. The entry of a substance in the Un ion list referred to in paragraph 2  may be initiated 
either on the initiative of the Commission or  following an application. Applications 
may be made by a Member State or by an interested party, who may also represent 
several interested parties (hereinafter referred to as the applicant). Applications shall be sent to the Commission, in  accordance with paragraph 4.  
4. The application shall include:  
(a) the name and the address of the applicant; (b) the name and a clear description of the substance  (c) the composition of the substance; (d) the proposed use of the substance and conditions thereof; (e) a systematic review of the scientific  data and appropriate studies performed 
following generally accepted expert guidance on the design and conduct of 
such studies;  
EN 25   EN (f) scientific evidence demonstrating the quantity of the substance which does not 
endanger the health of the persons to wh om it isintended and its suitability for 
the intended uses; 
(g) scientific evidence demonstrating that the substance is available for use by the 
human body;  
(h) a summary of the cont ent of the application. 
5. When a substance is already included in  the Union list and there is a significant 
change in the production met hods, or there is a change in  particle size, for example 
through nanotechnology, the substance prep ared by those new methods shall be 
considered as different substance and th e Union list shall be modified accordingly 
before it can be placed on the Union market. 
Article 12 
Confidential information relating to applications 
1. Among the information provided in the ap plication referred to in Article 11, 
confidential treatment may be given to in formation the disclosure of which might 
significantly harm the competitive position of the applicant.  
2. Information relating to the following shall not, in any circumstances, be regarded as 
confidential: 
(i) the name and address of the applicant; 
(ii) the name and description of the substance; 
(iii) the justification for the use of the substance in or on specific food; 
(iv) information that is relevant to the assessment of the safety of the substance; 
(v) where applicable, the analysis method(s) used by the applicant.  
3. Applicants shall indicate which of the info rmation provided they wish to be treated 
as confidential. Verifiable justifi cation must be given in such cases. 
4. The Commission shall decide after consulting with the a pplicants which information 
can remain confidential and shall notif y applicants and the Member States 
accordingly. 
5. After being made aware of the Commissi on’s position, applicants  shall have three 
weeks in which to withdraw their applicati on so as to preserve the confidentiality of 
the information provided. Confidentiality shal l be preserved until this period expires.  
EN 26   EN CHAPTER V 
CONFIDENTIALITY  
Article 13 
General confidentiality clause 
The Commission, the Authority and the Member St ates shall, in accordance with Regulation 
(EC) No 1049/2001, take the necessary measures to  ensure appropriate c onfidentiality of the 
information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the 
environment.  
CHAPTER VI 
PROCEDURAL PROVISIONS 
Article 14 
Committee 
1. The Commission shall be assisted by the Standing Committee on the Food Chain and 
Animal Health. That committee shall be  a committee within the meaning of 
Regulation (EU) No 182/2011. 
2. Where reference is made to this pa ragraph, Article 5 of Regulation (EU) 
No 182/2011 shall apply. 
Where the opinion of the committee is to be  obtained by writte n procedure, that 
procedure shall be terminated without re sult 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.  
3. Where reference is made to this pa ragraph, Article 8 of Regulation (EU) 
No 182/2011, in conjunction with Ar ticle 5 thereof, shall apply.  
Article 15 
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 delegation of power referred to in Ar ticles 2(3) and 10 of this Regulation shall 
be conferred  for an indeterminate period of time fro m the (*) [(*) Date of entry into 
force of the basic legislative act or fro m any other date set by the legislator.] 
3. The delegation of powers referred to in Articles 2(3) and 10 of this Regulation may 
be revoked at any time by the European Par liament or by the Council. A decision of 
revocation 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  
EN 27   EN Journal  of the European Union or at a later date specified therein. It shall not affect 
the validity of any delegate d acts already in force.  
4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  
5. A delegated act adopted pursuant to Artic les 2(3) and 10 of this Regulation shall 
enter into force only if no objection has been expressed either by the European 
Parliament or the Council within a period of 2 months of notifica tion of that act to 
the European Parliament and the Council or if, before the expiry of that period, the 
European Parliament and the Council have both informed the Commission that they 
will not object.  That period shall be extended by 2 months at the initiative of the 
European Parliament or the Council. 
Article 16 
Urgency procedure  
1. Delegated acts adopted under this Article shall enter into force without delay and 
shall apply as long as no objection is expr essed in accordance with paragraph 2. The 
notification of a  delegated act to the Eu ropean Parliament a nd to the Council shall 
state the reasons for the use of the urgency procedure. 
2. Either the European Parliament or the Council may object to a delegated act in 
accordance with the procedure referred to in Article 15. In such a case, the 
Commission shall repeal th e act without delay followi ng the notification of the 
decision to object by the Europ ean Parliament or the Council. 
CHAPTER VII 
FINAL PROVISIONS 
Article 17 
Repeal 
1. Directive 92/52/EEC and Direct ive 2009/39/EC are repealed from [the first day of 
the month 2 years after the date of the entry into force of this Regulation] . 
References to the repealed acts shall be c onstrued as references to this Regulation. 
2. Directive 96/8/EC and Regulation (EC) No 41/2009 are repealed from [the first day 
of the month 2 years after the date of the entry into force of this Regulation].   
Article 18 
Transitional measures 
Food not complying with this Regulation but  complying with Directives 2009/39/EC and 
96/8/EC, Regulations (EC) No 41/2009 a nd (EC) No 953/2009, and labelled prior to [2 years 
after the date of the entry in to force of this Regulation]  may continue to be marketed after that 
date until stocks are exhausted.   
EN 28   EN Article 19 
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 [ the first day of the month 2 years after the entry into force ], 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
For the European Parliament For the Council 
The President The President