CELEX: 52011PC0353
Language: en
Date: 2011-06-20
Title: 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

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		52011PC0353
		
			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 /* COM/2011/0353 final - 2011/0156 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           Context 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
provisions of Directive 2009/39/EC were originally adopted in 1977. After
several 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 designation under which a dietetic food is sold is accompanied by a
suitability statement for the particular nutritional use and the specific group
of the population to whom the food is intended, e.g.: gluten-free
food for celiac people, processed cereal-based food for young children, infant
formulae for infants from birth etc.
         After more than 30 years of
application, the evolution of both the food market and food legislation makes
an overall revision necessary. Indeed, the application of the broad concept of
"foodstuffs for particular nutritional uses" on which the Framework
Directive is based in the evolved market and legal context has led to
considerable problems for stakeholders and controlling authorities. The
classification of many foods as 'dietetic' foods and the need for such a
category of foods has been seriously questioned, although the desirability of
maintaining rules on certain specific categories of foods actually addressing
nutritional benefits for certain sub-groups of the population is being
recognised.
         Consequently, in pursuing the
objectives of better regulation and simplification, the proposal aims to
rectify this situation by simplifying and clarifying the rules that apply to
products hitherto regulated as 'dietetic' foods, taking into account the
evolution of the regulatory measures in relevant areas.
         Given the above, the proposal abolishes
the concept of dietetic foods and provides for a new framework establishing
general provisions only for a limited number of well-established and defined
categories of food that are considered as essential for certain vulnerable 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
proposal 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
the categories of food covered by this proposal. The currently existing three
different lists of substances included in three different legal measures would
be combined into a single one. Clarity for stakeholders and Member States and
better Union administration would be the outcome of the establishment of such a
merged measure.
         The revision of the legislation is
accompanied by an impact assessment giving an overview of the application of
Directive 2009/39/EC. 
·       General context
         The main objective of the Framework
Directive was to remove the differences between national laws relating to
foodstuffs for particular nutritional uses, thus allowing their free movement
and creating fair conditions of competitions.
         Discussions with Member States and
stakeholders have highlighted increasing difficulties for implementing the
Framework Directive, in particular in relation to more recent pieces of Union
legislation 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 legislation
governing it in order to ensure the functioning of the internal market and
guarantee the same level of protection to citizens across Europe.
         This unclear situation has led also
to distortions of trade in the internal market due to different interpretation
and enforcement 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 cover 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
Directive, Member States were asked for their views and experience on the
implementation of certain provisions of that Directive in order to prepare
Commission reports on 1) the implementation of the notification procedure of
the Framework Directive on dietetic foods and 2) the desirability of special
provisions for foods for persons suffering from carbohydrate-metabolism
disorders (diabetic foods). 
         As regards foods for diabetic people,
the Commission's report concludes that there is no scientific basis on which to
develop specific compositional requirements for this category of food and 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 requested to notify to the
competent authorities each product they want to market 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 resulting administrative burden
is significant for both the Member States and the company while the added value
in terms of public health and consumer information is questionable.
         All abovementioned issues led to the
need to consider an in depth and global revision of the legislation 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 intended
for particular nutritional uses, "the Framework Directive on dietetic
foods". The Directive lays down a common definition
on foods for particular nutritional uses as well as general provisions (e.g. a
general notification procedure for categories for foods not covered by specific
Commission legislation) and common labelling rules. 
          According to the definition, foods
for particular nutritional uses are foods that are different from foods for
normal consumption and are specially manufactured products intended to satisfy
the particular nutritional requirements of specific categories of the
population.
         Specific measures adopted for certain
categories of foods under that framework legislation are:
–              
Commission Directive 2006/141/EC on infant
formulae and follow-on formulae.
          This Directive was adopted
originally in 1991 and revised globally in 2006. It establishes detailed and
complete compositional and labelling rules for products intended to infants
from birth up to 12 months of age. Infant formulae are suitable as the sole
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 exported 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
originally in 1996 and was codified in 2006. This Directive covers foods that
are intended to be part of a diversified diet of infants and young 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 dietary
foods for special medical purposes.
          Dietary foods for special medical
purposes are intended for the exclusive or partial feeding of patients with
disturbed capacity to take ordinary 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 detailed labelling rules.
These foods are to be used under medical supervision. 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 categories of products intended
for weight control: products presented as a replacement for the whole daily diet
and products presented as a replacement for one or more meals of the daily
diet.
          It sets general compositional and
compulsory 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 period applies until 1 January 2012. It fixes gluten
thresholds and associated labelling rules for the voluntary indication of the
absence of gluten in products for people suffering from a permanent intolerance
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 substances 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
competitiveness of the European food industry, while ensuring the safety of
food, maintaining high level of public health protection and taking global
aspects into consideration. 
2.           Consultation of
interested parties and impact assessment
·       Consultation of
interested parties
         Consultation
methods, main sectors targeted and general profile of respondents
         There was a broad consultation of all
interested parties seeking their views on the provisions and application of
existing legislation and the need for change. The respondents were the
competent authorities of the Member States, industry association representatives
and consumer organisations.
         Summary
of responses and how they have been taken into account
–              
Consumer organisations main concern is that
certain foods are unduly covered by special designation/status under the
current Framework Directive which could put them out of the scope of other
important provisions – e.g. Regulation on Nutrition 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 this status allows the food to bear a suitability
statement that could be confused with a nutrition or health claim or make the
food appear more appropriate than a similar normal food.
–              
The specialised 'dietetic food' industry
believes that clear and transparent legislation governing the composition of
products for the dietetic food sector is essential to maintain the protection
of vulnerable groups of the population and those with special nutritional needs
from a public health and food safety perspective. In that context, they suggest
to strengthen the current legislation and to include 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 Birth Weight Formula'; 'Hospital
Discharge Formula'; 'Breast Milk Fortifier and Growing Up Milks'; 'Foods for
pregnant and lactating women'; '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
industry 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
shared 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 different
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 the industry. In addition, they fear that a legal
straight jacket may hamper innovation.
–              
Member States have reported that the legislation
on dietetic foods is being used by some operators to circumvent 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
most important aspect to maintain would be consumer safety. 
          The Commission identified in its
impact assessment supporting the proposal four options taking into account the
aforementioned issues and compared them in light of the objectives 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 Working 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 the different
options. 
         Two different approaches have been
considered: 
(1)     the notion of dietetic food is no
longer 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 foods for particular nutritional uses. In addition, the proposed rules
within each option would allow for market adaptation and therefore a sufficient
transitional period is foreseen to help have a smooth transition to the new legislation
and minimise economic burden.
         Summary of the options and the key
impacts under each of them:
·       Option 1 – Repeal all the legislation 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
statements 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
administrative burden, the trade off in terms of the introduction of national
legislation 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 Directive on dietetic foods
but maintain certain of the specific rules adopted under that Framework
         This option provides the same
simplification and administrative burden reduction benefits as option 1 but
also gives the Union the possibility to maintain for certain categories of
foods, rules the harmonisation of which has provided added value at EU level.
Having no general rules on dietetic foods anymore and clearer rules for certain
specific products 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 compositional and/or labelling
rules
         The main advantage of setting a
positive list for dietetic foods with specific compositional and labelling
rules is that standardised rules would apply to the dietetic food sector
ensuring harmonisation across the European Union. However, the burden that
would fall on the industry and Member States for having to comply with
additional specific dietetic food legislation to be able to target food to
certain groups of the population may be considered disproportionate
particularly taking into 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-authorisation procedure would ensure more harmonisation
across the European Union than the general notification procedure currently in
place. However, the burden of prior authorisation before using a 'dietetic'
suitability statement on a product seems to be disproportionate in terms of
consumers' protection and information 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 rules adopted under that Framework.
3.           Legal elements of the
proposal
·       Summary of the proposed action
         Adoption of a Regulation of the
European Parliament and of the Council establishing rules applicable to foods
intended for infants and young children and to foods for special medical purposes
and concerning a Union list of substances which can be added to the foods
covered by this proposal. 
         The proposal simplifies and clarifies
legal requirements 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 legislation
applying to well-defined categories of foods that have been identified as
essential for certain well-established groups of consumers with specific
nutritional needs;
–              
establishes a clear and defined 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 with 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
substances that can be added to the foods covered by this proposal;
          The new
proposal will repeal Directive 92/52/EC, Directive 2009/39/EC, Directive
96/8/EC and Regulation (EC) No 41/2009. 
          The
specific compositional and information requirements will be laid down in
delegated Regulations, adopted by the Commission, in accordance with Article 290
of the Treaty on the Functioning of the European Union (TFEU) taking into
account the general 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 criteria set out in this proposal
therefore implementing powers shall be conferred on the Commission 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 legal basis is justified both by the objective and the content of
the 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 and
information requirements for infant formulae and follow-on formulae, processed
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 framework for
products addressed to particular vulnerable parts of the population for which
categories of food constitute the sole source of nourishment. The objective of
the proposal is to avoid any differences between national laws relating to the
categories of food at issue impeding their free movement and thus having a
direct impact on the establishment and functioning of the internal market.
·       Subsidiarity principle
         The subsidiarity principle applies
insofar 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 Directive, 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
number 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 differing levels of food safety and protection of human health
and confuse consumers. In addition, it would endanger the free movement of
these foods in the Union.
         The core of the Union action would
maintain existing rules for certain products that are traded widely within the
Union and where there is agreement amongst Member States for the continuing
need for specific composition and labelling rules to ensure the free movement
of these goods. It also aims to simplify the regulatory environment as regards
the addition of substances to the foods covered by this proposal.
         The proposal therefore complies with
the subsidiarity principle.
·       Proportionality principle
         The proposal complies with the
proportionality principle for the following reason(s):
          The
proposal harmonises the regulatory 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 additional provisions contribute to consumer
protection by ensuring that consumers receive 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 internal market. At the same time they do not impose an
excessive or unjustified burden.
         The absence of harmonisation for
these categories of foods would result in a proliferation of national rules
resulting 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 applied. A Directive would have lead to an inconsistent approach in
the Union leading to uncertainty for both consumers and the industry. A Regulation
provides a consistent approach for industry to follow and reduces the
administrative burden as operators do not need to familiarise themselves with
the individual national legislation in the Member States.
         Soft law instruments such as
guidelines would be a flexible approach to addressing certain changes needed in
the current legislation but not all of them. In addition, due to the
non-binding status such instruments are considered not sufficient to tackle
differences in the interpretation and implementation of the legislation. 
4.           Budgetary implication
None.
5.           Additional 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
legislation 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 implementation
of the legislation.
         The provisions adopted in and under
Directive 2009/39/EC that have become unnecessary, contradictory and
potentially conflicting will be removed.
         The proposal is included in the
Commission Working Programme for 2011 – Annex III – Simplification Rolling
Programme 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 young children and to foods for special medical
purposes. It establishes also a single legal measure that regulates the list of
substances that 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 proposal 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 would apply to the categories of foods currently
regulated under Directive 2009/39/EC and the date of entry into force and
application.
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 Commission pursuant
to Article 114 of the Treaty on the Functioning of the European Union)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL 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
European Economic and Social Committee,
Acting in accordance with the ordinary
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
establishment 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 significantly to the
health and well-being of citizens, and to their social and economic interests.
(3)              
Directive 2009/39/EC of the European Parliament
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 the persons to whom they are
intended. The 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 requirements, including that such foods should bear an indication of
their suitability for the claimed nutritional purposes. 
(5)              
The general composition and labelling
requirements 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 harmonised rules with respect to infant formulae and follow-on
formulae[3], 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 children[4]. Similarly, harmonised
rules are also laid down by Commission Directive 96/8/EC of 26 February 1996 on
foods intended for use in energy-restricted diets for weight reduction[5],
Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special
medical purposes[6] and Commission Regulation
(EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of
foodstuffs suitable people intolerant to gluten[7].
(6)              
In addition, Council Directive 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 falling within the definition of foodstuffs for particular nutritional
uses: 'food intended to meet the expenditure of intense muscular effort,
especially for sportsmen' and 'food 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
reached 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 (diabetes), a Commission
report[9] concludes that the
scientific basis for setting specific compositional requirements is lacking. 
(8)              
Directive 2009/39/EC also requires a general
notification procedure at national level for food presented by food business
operators as falling under the definition of 'foodstuffs for particular
nutritional uses' and for which no specific provisions are laid 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 European
Parliament and the Council on the implementation of that notification procedure[10]
showed that difficulties may arise from different interpretations of the
definition of foodstuffs for particular nutritional uses which appeared to be
open to different interpretations by the national authorities. It therefore
concluded that a revision of the scope of Directive 2009/39/EC would be
required to ensure a more effective and harmonised implementation of the Union
legislation. 
(10)          
A study report[11]concerning the
revision of the legislation on foodstuffs for particular nutritional uses confirms
the findings of the Commission report on the implementation of the notification
procedure and indicates that an increasing number of foodstuffs are today
marketed and labelled as foodstuffs suitable 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 legislation differs
significantly between Member States; similar food could at the same time be marketed
in different Member States as food for particular nutritional 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 state of affairs undermines the functioning of the internal market,
creates legal uncertainty for competent authorities, food business operators
and consumers, while the risks of marketing abuse and distortion of competition
cannot be ruled out. 
(11)          
It appears that other Union acts recently adopted
are more adapted 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 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 December 2006 on nutrition and health claims made on foods[13]
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 other substances
to foods[14]. Furthermore, the
provisions of these Union acts would adequately regulate a number of the categories
of food covered by Directive 2009/39/EC with less administrative burden and
more clarity as to the scope and objectives. 
(12)          
Moreover, experience shows that certain rules
included in or adopted under Directive 2009/39/EC are no longer effective to ensure
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 the present act. To simplify its application and to
ensure consistency throughout the Member States, the present act should take
the form of a Regulation.
(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 in matters of food safety[15]
establishes common principles and definitions for Union food law in order to
ensure a high level of health 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 for the scientific and technical
evaluations which are undertaken by the European Food Safety Authority
(hereinafter referred to as 'the Authority'). Therefore, certain definitions
laid down in that Regulation must also apply in the context of the present
Regulation. Moreover, for the purpose of this Regulation, the Authority should
be consulted on all matters likely to affect public health. 
(15)          
A limited number of categories of food
constitutes the sole source of nourishment of certain groups of the population
or represent a partial source of nourishment; such categories of food are vital
for the management of certain conditions and/or are essential to maintain the
intended nutritional adequacy for certain well-established vulnerable groups of
the population. Those categories of food include infant formulae and follow-on
formulae, processed cereal-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 the free movement of such food 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
compositional and information requirements for infant formula 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 account
Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and
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 are
appropriate to satisfy the nutritional requirements of, and are suitable for
the persons to whom they are intended and that their nutritional adequacy has
been established by generally accepted scientific data. Such adequacy should be
demonstrated through a systematic review of the available scientific data. 
(18)          
General labelling requirements are laid down in
Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000
on the approximation of the law of the Member States relating to labelling,
presentation and advertising of foodstuffs[16]. 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 meet the specific objectives
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
food, and food for special medical purposes, taking into account Commission
Directive 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, processed 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 developments at
international level, to lay down the specific compositional and information
requirements with respect to the categories of food covered by this Regulation,
including for additional labelling requirements to, or derogations from, the
provisions of Directive 2000/13/EC and for the authorisation of nutrition and
health claims, the power to adopt acts in accordance
with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. It is of
particular importance that the Commission carries out appropriate consultations
during its preparatory work, including at expert level. The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission 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 food, 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 application of criteria set out in this Regulation, implementing
powers should be conferred on the Commission in that respect. 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 States
of the Commission's exercise of implementing powers[17].
The Commission should adopt immediately applicable implementing acts updating
the Union list, where, in duly justified cases relating to public health,
imperative 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
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 Regulation, until an
evaluation by the Authority is carried out. 
(22)          
In the interests of efficiency and legislative
simplification, there should be a medium-term examination of the question
whether to extend the scope of the 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
Regulation constitutes a serious risk to human health. In order to ensure
uniform conditions for the implementation of emergency measures, implementing
powers should be conferred on the Commission. Those powers should be exercised in
accordance with Regulation (EU) No 182/2011. The Commission should adopt
immediately applicable implementing acts relating to emergency measures, where,
in duly justified 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 comply with Union law unless otherwise required by the importing
country. This principle has already been established for food in Regulation
(EC) No 178/2002. For the sake of simplification and legal certainty, Directive
92/52/EEC should therefore be repealed. 
(25)          
Regulation (EC) No 1924/2006 of the European
Parliament and of the Council of 20 December 2006 on nutrition and health
claims made on foods[19] establishes the rules
and conditions for the use of nutrition and health claims on food. Those rules
should apply as a general rule to the categories of food covered by this
Regulation, unless otherwise specified in this Regulation or non-legislative
acts adopted pursuant to this Regulation.
(26)          
Currently, the statements 'gluten-free' and
'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 Regulation
(EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable
for people intolerant to gluten[20]. 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 'gluten-free' and 'very low gluten' and
their associated conditions of use as regulated under Regulation (EC) No
41/2009 be completed prior to the entry into application of this Regulation. 
(27)          
'Meal replacement for weight control' and 'total
diet replacement for weight control' are considered as food for particular
nutritional uses and are 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 presented as health
claims for weight control. In order to eliminate any potential confusion
between food marketed for weight control and in the interests of legal
certainty and coherence of Union legislation, such 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 health claims referring to the body weight
control for food presented as 'total diet replacement for weight control' and
as 'meal replacement for weight control' and associated conditions of use 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
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 accordance 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.
(29)          
Adequate transitional measures are necessary to
enable food business 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 the 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, the 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;
(b)     the definitions of 'labelling' and
'pre-packaged 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
infants 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
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 the following four
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;
–              
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 their progressive adaptation to ordinary food, excluding:
(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, metabolise or excrete ordinary food or certain nutrients contained
therein, or with other medically-determined nutrient requirements, whose
dietary management cannot be achieved only by modification of the normal diet.
3.           The Commission shall be empowered
to adopt delegated acts in accordance with Article 15 to adapt the definitions
of 'infant formula', 'follow-on formula', 'processed cereal-based food' and
'baby food' and 'food for special medical purposes' taking into account technical
and scientific progress and relevant developments 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 allowed 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 State(s) concerned, the Commission on its own initiative or at the
request of a Member 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.
Those measures shall be adopted by means of implementing acts in accordance
with the examination procedure referred to in Article 14(2). 
2.           On duly justified imperative
grounds of extreme urgency to contain and/or address a serious risk to human
health, the Commission shall adopt immediately applicable implementing acts in
accordance with the procedure referred to in Article 14(3). 
3.           Where a Member State officially
informs the Commission of the need to take emergency measures and the
Commission has not acted in accordance with paragraph 1, the Member State
concerned may adopt any appropriate interim emergency measures, restricting 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 States and the Commission thereof, giving the grounds for its
decision. The Commission shall adopt implementing acts aiming at extending,
amending or abrogating the national interim emergency measures. Those
implementing acts shall be adopted in accordance with the examination 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 prevail over any other conflicting requirement of Union
law applicable to food.
Article 8
Opinions of the Authority 
The European Food Safety Authority shall
provide 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 generally accepted scientific data. 
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 and
advertising of food referred to in Article 1(1) shall provide adequate consumer
information and must not be misleading. 
4.           The dissemination of any useful
information or recommendations with reference to the categories of food
referred to in Article 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 comply 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, the Commission shall be empowered to adopt delegated
Regulations, no later than [2 years after the date of the entry into force
of this Regulation], in accordance with Article 15, with 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 the
authorisation of nutrition and health claims thereof;
(d)     the notification procedure for the
placing on the market of a food referred to in Article 1(1) in order to
facilitate the efficient official monitoring of such food on the basis of which
food operators shall 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 into account relevant technical and scientific
progress, the Commission shall update the delegated Regulations mentioned in
paragraph 2 in accordance with Article 15. 
Where in the case of emerging health risks, 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
scientific 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 implementing 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 applicable implementing acts updating the
Union list in accordance with Article 14(3).
3.           The entry of a substance in the Union
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;
(f)      scientific evidence demonstrating the
quantity of the substance which does not endanger the health of the persons to
whom 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 content of the
application.
5.           When a substance is already
included in the Union list and there is a significant change in the production
methods, or there is a change in particle size, for example through
nanotechnology, the substance prepared by those new methods shall be considered
as different substance and the 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 application referred to in Article 11, confidential treatment may be given
to information 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 information provided they wish to be treated as confidential. Verifiable
justification must be given in such cases.
4.           The Commission shall decide after
consulting with the applicants which information can remain confidential and
shall notify applicants and the Member States accordingly.
5.           After being made aware of the
Commission’s position, applicants shall have three weeks in which to withdraw
their application so as to preserve the confidentiality of the information provided.
Confidentiality shall be preserved until this period expires.
CHAPTER V
CONFIDENTIALITY 
Article 13
General confidentiality clause
The Commission, the Authority and the
Member States shall, in accordance with Regulation (EC) No 1049/2001, take the
necessary measures to ensure appropriate confidentiality 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
paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the opinion of the committee is to be
obtained by written procedure, that 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. 
3.           Where reference is made to this
paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article
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 Articles 2(3) and 10 of this Regulation shall be conferred for an
indeterminate period of time from the (*) [(*)  Date of entry into force of the
basic legislative act or from 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 Parliament 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
Journal of the European Union or at a later date specified therein.
It shall not affect the validity of any delegated 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 Articles 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 notification 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 expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and 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 the act
without delay following the notification of the
decision to object by the European Parliament or the Council.
CHAPTER VII
FINAL PROVISIONS
Article 17
Repeal
1.           Directive 92/52/EEC and
Directive 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 construed 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 and (EC) No 953/2009, and labelled prior to [2
years after the date of the entry into force of this Regulation] may
continue to be marketed after that date until stocks are exhausted. 
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
[1]               Position of the European Parliament of … and position
of the Council at first reading of ... Position of the European Parliament of
... and decision of the Council of ....
[2]               OJ L 124, 20.5.2009, p. 21.
[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.
[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, social 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.
[15]             OJ L 31, 1.2.2002, p. 1. 
[16]             OJ L 184, 17.7.1999, p. 23.
[17]             OJ L 55, 28.2.2011, p. 13.
[18]             Scientific Committee established by Commission Decision
of 5 August 2008 setting up an advisory structure of Scientific Committees and
experts in the 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.
[19]             OJ L 404, 30.12.2006, p. 9.
[20]             OJ L 14, 20.1.2009, p.
5.