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29.6.2013 Official
Journal
of
the
European
Union L
181/35
REGULATION (EU) No 609/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 12 June 2013
on food intended for infants and young children, food for special medical purposes, and total diet
replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives
96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European
Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
(3) Union
law
applicable
to
food
is
intended,
inter
alia,
to
EUROPEAN UNION,
ensure that no food is placed on the market if it is
unsafe. Therefore, any substances that are considered to
be injurious to the health of the population groups
concerned or unfit for human consumption should be
Having regard to the Treaty on the Functioning of the European
excluded from the composition of the categories of food
Union, and in particular Article 114 thereof,
covered by this Regulation.
Having regard to the proposal from the European Commission,
(4) Directive
2009/39/EC
of
the
European
Parliament
and
of
the Council of 6 May 2009 on foodstuffs intended for
particular nutritional uses ( 3 ) lays down general rules on
the composition and preparation of foods that are
After transmission of the draft legislative act to the national
specially designed to meet the particular nutritional
parliaments,
requirements of the persons for whom they are
intended. The majority of the provisions laid down in
that Directive date back to 1977 and need to be
reviewed.
Having regard to the opinion of the European Economic and
Social Committee ( 1 ),
(5) Directive
2009/39/EC
establishes
a
common
definition
for ‘foodstuffs for particular nutritional uses’, and
general labelling requirements, including that such
Acting in accordance with the ordinary legislative procedure ( 2 ),
foods should bear an indication of their suitability for
the nutritional purposes being claimed.
Whereas:
(6) The
general
compositional
and
labelling
requirements
laid down in Directive 2009/39/EC are complemented
by a number of non-legislative Union acts, which are
(1)
Article 114 of the Treaty on the Functioning of the
applicable to specific categories of food. In that respect,
European Union (TFEU) provides that, for measures
harmonised rules are laid down in Commission
having as their object the establishment and functioning
Directives 96/8/EC of 26 February 1996 on foods
of the internal market, and which concern, inter alia,
intended for use in energy-restricted diets for weight
health, safety and consumer protection, the Commission
reduction ( 4 ) and 1999/21/EC of 25 March 1999 on
is to take as a base a high level of protection taking
dietary foods for special medical purposes ( 5 ). Similarly,
account in particular of any new development based
Commission Directive 2006/125/EC ( 6 ) lays down certain
on scientific facts.
harmonised rules with respect to processed cereal-based
foods and baby foods for infants and young children.
Commission Directive 2006/141/EC
( 7 ) lays down
harmonised rules with respect to infant formulae and
(2) The
free
movement
of
safe
and
wholesome
food
is
an
follow-on formulae and Commission Regulation (EC)
essential aspect of the internal market and contributes
No 41/2009 ( 8 ) lays down harmonised rules concerning
significantly to the health and well-being of citizens,
the composition and labelling of foodstuffs suitable for
and to their social and economic interests.
people intolerant to gluten.
( 1 ) OJ C 24, 28.1.2012, p. 119.
( 3 ) OJ L 124, 20.5.2009, p. 21.
( 2 ) Position of the European Parliament of 14 June 2012 (not yet
( 4 ) OJ L 55, 6.3.1996, p. 22.
published in the Official Journal) and position of the Council at
( 5 ) OJ L 91, 7.4.1999, p. 29.
first reading of 22 April 2013 (not yet published in the Official
( 6 ) OJ L 339, 6.12.2006, p. 16.
Journal). Position of the European Parliament of 11 June 2013
( 7 ) OJ L 401, 30.12.2006, p. 1.
(not yet published in the Official Journal).
( 8 ) OJ L 16, 21.1.2009, p. 3.

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L 181/36
EN
Official Journal of the European Union
29.6.2013
(7) In
addition,
harmonised
rules
are
laid
down
in
Council (11) It appears that other, recently adopted, Union legal acts
Directive 92/52/EEC of 18 June 1992 on infant formulae
are more adapted to an evolving and innovative food
and follow-on formulae intended for export to third
market than Directive 2009/39/EC. Of particular
countries ( 1 ) and in Commission Regulation (EC) No
relevance and importance in that respect are: Directive
953/2009 of 13 October 2009 on substances that may
2002/46/EC of the European Parliament and of the
be added for specific nutritional purposes in foods for
Council of 10 June 2002 on the approximation of the
particular nutritional uses ( 2 ).
laws of the Member States relating to food supple
ments ( 3 ), 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 ( 4 )
and Regulation (EC) No 1925/2006 of the European
Parliament and of the Council of 20 December 2006
(8) Directive
2009/39/EC
requires
a
general
notification
procedure at national level for food presented by food
on the addition of vitamins and minerals and of
business operators as coming within the definition of
certain other substances to foods ( 5 ). Furthermore, the
‘foodstuffs for particular nutritional uses’ for which no
provisions of those Union legal acts would adequately
specific provisions have been laid down in Union law,
regulate a number of the categories of food covered by
prior to its being placed on the Union market, in order
Directive 2009/39/EC with less of an administrative
to facilitate the efficient monitoring of such food by the
burden and more clarity as to scope and objectives.
Member States.
(12) Moreover,
experience
shows
that
certain
rules
included
in, or adopted under, Directive 2009/39/EC are no
(9) A
report
from
the
Commission
of
27
June
2008
to
the
longer effective in ensuring the functioning of the
European Parliament and to the Council on the imple
internal market.
mentation of that notification procedure showed that
difficulties can arise from the definition of ‘foodstuffs
for particular nutritional uses’ which appeared to be
open to differing interpretations by the national auth
(13) Therefore,
the
concept
of
‘foodstuffs
for
particular
nutri
orities. It therefore concluded that a revision of
tional uses’ should be abolished and Directive
Directive 2009/39/EC would be required to ensure a
2009/39/EC should be replaced by this act. To simplify
more effective and harmonised implementation of
the application of this act and to ensure consistency of
Union legal acts.
application throughout the Member States, this act
should take the form of a Regulation.
(10) A study report of 29 April 2009 by Agra CEAS
Consulting, concerning the revision of Directive
(14) Regulation (EC) No 178/2002 of the European
2009/39/EC, confirmed the findings of the Commission
Parliament and of the Council of 28 January 2002
report of 27 June 2008 on the implementation of the
laying down the general principles and requirements of
notification procedure and indicated that an increasing
food law, establishing the European Food Safety
number of foodstuffs are currently marketed and
Authority and laying down procedures in matters of
labelled as foodstuffs suitable for particular nutritional
food safety ( 6 ) establishes common principles and defi
uses, due to the broad definition laid down in that
nitions for Union food law. Certain definitions laid
Directive. The study report also pointed out that food
down in that Regulation should also apply in the
regulated under that Directive differs significantly
context of this Regulation.
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, including food supplements, addressed to
(15) A
limited
number
of
categories
of
food
constitute
a
the population in general or to certain subgroups thereof
partial or the sole source of nourishment for certain
such as pregnant women, postmenopausal women, older
population groups. Such categories of food are vital for
adults, growing children, adolescents, variably active indi
the management of certain conditions and/or are
viduals and others. This state of affairs undermines the
essential to satisfy the nutritional requirements of
functioning of the internal market, creates legal uncer
certain clearly identified vulnerable population groups.
tainty for competent authorities, food business operators,
Those categories of food include infant formula and
in particular small and medium-sized enterprises (SMEs),
follow-on formula, processed cereal-based food and
and consumers, while the risks of marketing abuse and
baby food, and food for special medical purposes.
distortion of competition cannot be ruled out. There is
Experience has shown that the provisions laid down in
therefore a need to eliminate differences in interpretation
by simplifying the regulatory environment.
( 3 ) OJ L 183, 12.7.2002, p. 51.
( 4 ) OJ L 404, 30.12.2006, p. 9.
( 1 ) OJ L 179, 1.7.1992, p. 129.
( 5 ) OJ L 404, 30.12.2006, p. 26.
( 2 ) OJ L 269, 14.10.2009, p. 9.
( 6 ) OJ L 31, 1.2.2002, p. 1.

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EN
29.6.2013 Official
Journal
of
the
European
Union L
181/37
Directives 1999/21/EC, 2006/125/EC and 2006/141/EC
for, the persons for whom such food is intended and that
ensure the free movement of those categories of food in
their nutritional adequacy has been established by
a satisfactory manner, while ensuring a high level of
generally accepted scientific data. Such adequacy should
protection of public health. It is therefore appropriate
be demonstrated through a systematic review of the
that this Regulation focuses on the general compositional
available scientific data.
and information requirements for those categories of
food, taking into account Directives 1999/21/EC,
2006/125/EC and 2006/141/EC.
(20) Maximum
residue
levels
of
pesticides
set
out
in
relevant
Union law, in particular Regulation (EC) No 396/2005 of
(16) In
addition,
in
view
of
the
growing
rates
of
people
with
the European Parliament and of the Council of
problems related to being overweight or obese, an
23 February 2005 on maximum residue levels of
increasing number of foods are placed on the market
pesticides in or on food and feed of plant and animal
as total diet replacement for weight control. Currently,
origin ( 1 ), should apply without prejudice to specific
for such foods present in the market a distinction can be
provisions set out in this Regulation and delegated acts
made between products intended for low calorie diets,
adopted pursuant to this Regulation.
which contain between 3 360 kJ (800 kcal) and 5 040 kJ
(1 200 kcal), and products intended for very low calorie
diets, which normally contain fewer than 3 360 kJ
(800 kcal). Given the nature of the foods in question it
is appropriate to lay down certain specific provisions for
them. Experience has shown that the relevant provisions
laid down in Directive 96/8/EC ensure the free
(21) The
use
of
pesticides
can
lead
to
pesticide
residues
in
movement of foods presented as total diet replacement
food that is covered by this Regulation. Such use
for weight control in a satisfactory manner while
should, therefore, be restricted as much as possible,
ensuring a high level of protection of public health. It
taking into account the requirements of Regulation (EC)
is therefore appropriate that this Regulation focuses on
No 1107/2009 of the European Parliament and of the
the general compositional and information requirements
Council of 21 October 2009 concerning the placing of
for foods intended to replace the whole of the daily diet
plant protection products on the market ( 2 ). However, a
including foods of which the energy content is very low,
restriction on, or a prohibition of, use would not
taking into account the relevant provisions of Directive
necessarily guarantee that food covered by this Regu
96/8/EC.
lation, including food for infants and young children, is
free from pesticides, since some pesticides contaminate
the environment and their residues can be found in such
food. Therefore, the maximum residue levels in such food
should be set at the lowest achievable level to protect
vulnerable population groups, taking into account good
agricultural practices as well as other sources of exposure,
(17) This
Regulation
should
establish,
inter
alia,
definitions
of
infant formula and follow-on formula, processed cereal-
such as environmental contamination.
based food and baby food, food for special medical
purposes, and total diet replacement for weight control,
taking into account relevant provisions in Directives
96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC.
(22) Restrictions
on
and
prohibitions
of
certain
pesticides
equivalent to those currently established in the Annexes
to Directives 2006/125/EC and 2006/141/EC should be
taken into account in delegated acts adopted pursuant to
(18) Regulation
(EC)
No
178/2002
establishes
the
principles
this Regulation. Those restrictions and prohibitions
of risk analysis in relation to food and establishes the
should be updated regularly, with particular attention
structures and mechanisms for the scientific and
to be paid to pesticides containing active substances,
technical evaluations which are undertaken by the
safeners or synergists classified in accordance with Regu
European Food Safety Authority (‘the Authority’). For
lation (EC) No 1272/2008 of the European Parliament
the purpose of this Regulation, the Authority should be
and of the Council of 16 December 2008 on classifi
consulted on all matters likely to affect public health.
cation, labelling and packaging of substances and
mixtures ( 3 ) as mutagen category 1A or 1B, carcinogen
category 1A or 1B, toxic for reproduction category 1A or
1B, or considered to have endocrine-disrupting properties
that can cause adverse effects in humans.
(19) It is important that ingredients used in the manufacture
( 1 ) OJ L 70, 16.3.2005, p. 1.
of food covered by this Regulation are appropriate for
( 2 ) OJ L 309, 24.11.2009, p. 1.
satisfying the nutritional requirements of, and are suitable
( 3 ) OJ L 353, 31.12.2008, p. 1.

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L 181/38
EN
Official Journal of the European Union
29.6.2013
(23) Substances
falling
within
the
scope
of
Regulation
(EC)
No
formula and follow-on formula, all written and pictorial
258/97 of the European Parliament and of the Council of
information should enable a clear distinction to be made
27 January 1997 concerning novel foods and novel food
between different formulae. Difficulty in identifying the
ingredients ( 1 ) should not be added to food covered by
precise age of an infant pictured on labelling could
this Regulation unless such substances fulfil the
confuse consumers and impede product identification.
conditions for being placed on the market under Regu
That risk should be avoided by appropriate restrictions
lation (EC) No 258/97 in addition to the conditions set
on labelling. Furthermore, taking into account that infant
out in this Regulation and delegated acts adopted
formula constitutes food that satisfies by itself the nutri
pursuant to this Regulation. When there is a significant
tional requirements of infants from birth until intro
change in the production method of a substance that has
duction of appropriate complementary feeding, proper
been used in accordance with this Regulation or a change
product identification is crucial for the protection of
in particle size of such a substance, for example through
consumers. Appropriate restrictions should, therefore,
nanotechnology, that substance should be considered
be introduced concerning the presentation and adver
different from the one that has been used in accordance
tising of infant formula.
with this Regulation and should be re-evaluated under
Regulation (EC) No 258/97 and subsequently under
this Regulation.
(27) This
Regulation
should
provide
the
criteria
for
the
estab
lishment of the specific compositional and information
(24) Regulation (EU) No 1169/2011 of the European
requirements for infant formula, follow-on formula,
Parliament and of the Council of 25 October 2011 on
processed cereal-based food and baby food, food for
the provision of food information to consumers (
special medical purposes, and total diet replacement for

2 ) lays
down general labelling requirements. Those labelling
weight control, taking into account Directives 96/8/EC,
requirements should, as a general rule, apply to the
1999/21/EC, 2006/125/EC and 2006/141/EC.
categories of food covered by this Regulation. However,
this Regulation should also provide for additional
requirements to, or derogations from, Regulation (EU)
No 1169/2011, where necessary, in order to meet the
specific objectives of this Regulation.
(28) Regulation
(EC)
No
1924/2006
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 delegated acts
(25) The
labelling,
presentation
or
advertising
of
food
covered
adopted pursuant to this Regulation.
by this Regulation should not attribute to such food the
property of preventing, treating or curing a human
disease nor should they imply such properties. Food for
special medical purposes, however, is intended for the
dietary management of patients with a limited,
impaired or disturbed capacity, for example, to take
ordinary food because of a specific disease, disorder or
medical condition. Reference to the dietary management
of diseases, disorders or medical conditions for which the
(29) According
to
the
recommendations
of
the
World
Health
food is intended should not be considered as attribution
Organisation (WHO), low birth weight infants should be
of the property of preventing, treating or curing a human
fed mother’s milk. Nonetheless, low birth weight infants
disease.
and pre-term infants may have special nutritional
requirements which cannot be met by mother’s milk or
standard infant formula. In fact, the nutritional
requirements of a low birth weight infant and a pre-
term infant can depend on the medical condition of
that infant, in particular on that infant’s weight in
comparison with that of an infant in good health, and
on the number of weeks the infant is premature. It is to
(26) In the interest of protecting vulnerable consumers,
be decided on a case-by-case basis whether the infant’s
labelling requirements should ensure accurate product
condition requires the consumption, under medical
identification for consumers. In the case of infant
supervision, of a food for special medical purposes
developed to satisfy the nutritional requirements of
( 1 ) OJ L 43, 14.2.1997, p. 1.
infants (formula) and adapted for the dietary
( 2 ) OJ L 304, 22.11.2011, p. 18.
management of that infant’s specific condition.

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29.6.2013 Official
Journal
of
the
European
Union L
181/39
(30) Directive
1999/21/EC
requires
that
certain
compositional
disorders (diabetes), a Commission report to the
requirements for infant formula and for follow-on
European Parliament and to the Council of 26 June
formula as set out in Directive 2006/141/EC apply to
2008 on foods for persons suffering from carbohydrate
food for special medical purposes intended for infants,
metabolism disorders (diabetes) concluded that the
depending on their age. However, certain provisions,
scientific basis for setting specific compositional
including those relating to labelling, presentation, adver
requirements is lacking. With regard to food intended
tising, and promotional and commercial practices, set out
to meet the expenditure of intense muscular effort,
in Directive 2006/141/EC currently do not apply to such
especially for sportsmen, no successful conclusion could
food. Developments in the market accompanied by a
be reached as regards the development of specific
significant increase of such food make it necessary to
provisions due to widely diverging views among the
review requirements for formulae intended for infants
Member States and stakeholders concerning the scope
such as requirements on the use of pesticides in
of specific legislation, the number of subcategories of
products intended for production of such formulae,
food to be included, the criteria for establishing composi
pesticide residues, labelling, presentation, advertising,
tional requirements and the potential impact on inno
and promotional and commercial practices that should
vation in product development. Therefore, specific
also apply, as appropriate, to food for special medical
provisions should not be developed at this stage. Mean
purposes developed to satisfy the nutritional
while, on the basis of requests submitted by food
requirements of infants.
business operators, relevant claims have been considered
for authorisation in accordance with Regulation (EC) No
1924/2006.
(31) There
is
an
increasing
number
of
milk-based
drinks
and
similar products on the Union market which are
promoted as being particularly suitable for young
(33) However,
different
views
exist
as
to
whether
additional
children. Such products, which can be derived from
rules are needed to ensure an adequate protection of
protein of animal or vegetable origin such as cows’
consumers of food intended for sportsmen, also called
milk, goats’ milk, soy or rice, are often marketed as
food intended to meet the expenditure of intense
‘growing up milks’ or ‘toddlers’ milks’ or with similar
muscular effort. The Commission should, therefore, be
terminology. While these products are currently
invited, after consulting the Authority, to submit to the
regulated by different legal acts of the Union, such as
European Parliament and to the Council a report on the
Regulations (EC) No 178/2002, (EC) No 1924/2006
necessity, if any, of provisions concerning food intended
and (EC) No 1925/2006, and Directive 2009/39/EC,
for sportsmen. The consultation of the Authority should
they are not covered by the existing specific measures
take into account the report of 28 February 2001 of the
applying to food intended for infants and young
Scientific Committee on Food on composition and spec
children. Different views exist as to whether such
ification of food intended to meet the expenditure of
products satisfy the specific nutritional requirements of
intense muscular effort, especially for sportsmen. In its
the population group they target. The Commission
report, the Commission should, in particular, evaluate
should therefore, after consulting the Authority, present
whether provisions are necessary to ensure the protection
to the European Parliament and to the Council a report
of consumers.
on the necessity, if any, of special provisions regarding
the composition, labelling and other types of require
ments, if appropriate, of those products. This report
should consider, inter alia, the nutritional requirements
of young children and the role of those products in their
(34) The
Commission should be able to adopt technical
diet, taking into account the pattern of consumption, the
guidelines aimed at facilitating compliance by food
nutritional intake and the levels of exposure of young
business operators, in particular SMEs, with this Regu
children to contaminants and pesticides. The report
lation.
should also consider the composition of such products
and whether they have any nutritional benefits when
compared to a normal diet for a child who is being
weaned. The Commission could accompany this report
with a legislative proposal.
(35) Taking into account the existing situation on the market
and Directives 2006/125/EC and 2006/141/EC, and
Regulation (EC) No 953/2009, it is appropriate to
establish and include in the Annex to this Regulation a
Union list of substances belonging to the following
(32) Directive
2009/39/EC
provides
that
specific
provisions
categories of substances: vitamins, minerals, amino
can be adopted regarding the following two specific
acids, carnitine and taurine, nucleotides, choline and
categories of food falling within the definition of food
inositol. Among the substances belonging to those
stuffs for particular nutritional uses: ‘food intended to
categories, it should only be permissible for those
meet the expenditure of intense muscular effort,
included in the Union list to be added to the categories
especially for sportsmen’ and ‘food for persons
of food covered by this Regulation. When substances are
suffering from carbohydrate metabolism disorders (dia
included in the Union list, it should be specified to which
betes)’. As regards special provisions for food for
category of food covered by this Regulation such
persons suffering from carbohydrate metabolism
substances may be added.

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L 181/40
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Official Journal of the European Union
29.6.2013
(36) The inclusion of substances in the Union list should not
respect of the regular updating of those specific require
mean that their addition to one or more categories of
ments, taking into account all relevant data, including
food covered by this Regulation is necessary or desirable.
data provided by interested parties. In addition, in
The Union list is intended only to reflect which
order to take into account technical progress, scientific
substances belonging to certain categories of substances
developments or consumers’ health, the power to adopt
are authorised to be added to one or more categories of
acts in accordance with Article 290 TFEU should be
food covered by this Regulation, whereas the specific
delegated to the Commission in respect of the addition
compositional requirements are intended to establish
of categories of substances that have a nutritional or
the composition of each category of food covered by
physiological effect to be covered by the Union list, or
this Regulation.
in respect of the removal of such categories from the
categories of substances covered by the Union list. For
the same purposes and subject to additional requirements
laid down in this Regulation, the power to adopt
delegated acts in accordance with Article 290 TFEU
should also be delegated to the Commission in respect
of amending the Union list by adding a new substance,
removing a substance or adding, removing or amending
(37) A
number
of
the
substances
that
may
be
added
to
food
covered by this Regulation could be added for tech
the elements in the Union list related to a substance. It is
nological purposes as food additives, colourings or
of particular importance that the Commission carry out
flavourings, or for other such purposes, including auth
appropriate consultations during its preparatory work,
orised oenological practices and processes, provided for
including at expert level. The Commission, when
by relevant Union legal acts applicable to food. In this
preparing and drawing up delegated acts, should ensure
context specifications are adopted for those substances at
a simultaneous, timely and appropriate transmission of
Union level. It is appropriate that those specifications
relevant documents to the European Parliament and to
should be applicable to the substances whatever the
the Council.
purpose of their use in food unless otherwise provided
for by this Regulation.
(40) In
order
to
ensure
uniform
conditions
for
the
implemen
tation of this Regulation, implementing powers should be
(38) For the substances included in the Union list for which
conferred on the Commission to decide whether a given
purity criteria have not yet been adopted at Union level,
food falls within the scope of this Regulation and to
and in order to ensure a high level of protection of
which category of food it belongs. Those powers
public health, generally acceptable purity criteria recom
should be exercised in accordance with Regulation (EU)
mended by international organisations or agencies
No 182/2011 of the European Parliament and of the
including but not limited to the Joint FAO/WHO
Council of 16 February 2011 laying down the rules
Expert Committee on Food Additives (JECFA) and
and general principles concerning mechanisms for
European Pharmacopoeia should apply. Member States
control by Member States of the Commission’s exercise
should be permitted to maintain national rules setting
of implementing powers ( 1 ).
stricter purity criteria, without prejudice to the rules set
out in the TFEU.
(41) Currently,
the
rules
on
the
use
of
the
statements
‘gluten-
(39) In
order
to
specify
requirements
for
the
categories
of
free’ and ‘very low gluten’ are specified in Regulation (EC)
food covered by this Regulation, the power to adopt
No 41/2009. That Regulation harmonises the
acts in accordance with Article 290 TFEU should be
information that is provided to consumers on the
delegated to the Commission in respect of the laying
absence or reduced presence of gluten in food and sets
down of specific compositional and information
specific rules for food that is specially produced, prepared
requirements with regard to the categories of food
and/or processed in order to reduce the gluten content of
covered by this Regulation, including additional
one or more gluten-containing ingredients or to
labelling requirements to, or derogations from, Regu
substitute such gluten-containing ingredients and other
lation (EU) No 1169/2011 and with regard to the auth
food that is made exclusively from ingredients that are
orisation of nutrition and health claims. Furthermore, in
naturally free of gluten. Regulation (EU) No 1169/2011
order to enable consumers to benefit rapidly from
sets out rules on information to be provided for all food,
technical and scientific progress, especially in relation
including non-prepacked food, on the presence of
to innovative products, and thus to stimulate innovation
ingredients, such as gluten-containing ingredients, with
the power to adopt acts in accordance with Article 290
TFEU should also be delegated to the Commission in
( 1 ) OJ L 55, 28.2.2011, p. 13.

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EN
29.6.2013 Official
Journal
of
the
European
Union L
181/41
a scientifically proven allergenic or intolerance effect in
of food presented as ‘meal replacement for weight
order to enable consumers, particularly those suffering
control’, and to the conditions of use of such claims,
from a food allergy or intolerance such as gluten-
as regulated by Directive 96/8/EC, be completed prior
intolerant people, to make informed choices which are
to the application of this Regulation.
safe for them. For the sake of clarity and consistency, the
rules on the use of the statements ‘gluten-free’ and ‘very
low gluten’ should also be regulated under Regulation
(EU) No 1169/2011. The legal acts to be adopted
pursuant to Regulation (EU) No 1169/2011, which are
to transfer the rules on the use of the statements ‘gluten-
free’ and ‘very low gluten’, as contained in Regulation
(44) This
Regulation
does
not
affect
the
obligation
to
respect
(EC) No 41/2009, should ensure at least the same level
fundamental rights and fundamental legal principles,
of protection for people who are intolerant to gluten as
including the freedom of expression, as enshrined in
currently provided for under Regulation (EC) No
Article 11, in conjunction with Article 52, of the
41/2009. That transfer of rules should be completed
Charter of Fundamental Rights of the European Union,
before this Regulation applies. Furthermore, the
and in other relevant provisions.
Commission should consider how to ensure that
people who are intolerant to gluten are adequately
informed of the difference between a food that is
specially produced, prepared and/or processed in order
to reduce the gluten content of one or more gluten-
containing ingredients and other food that is made
(45) Since the objectives of this Regulation, namely, the estab
exclusively from ingredients naturally free of gluten.
lishment of compositional and information requirements
for certain categories of food, the establishment of a
Union list of substances that may be added to certain
categories of food and the establishment of the rules for
the update of the Union list, cannot be sufficiently
achieved by the Member States and can therefore, by
(42) Labelling
and
compositional
rules
indicating
the
absence
reason of the scale of the proposed action, be better
or reduced presence of lactose in food are currently not
achieved at Union level, the Union may adopt
harmonised at Union level. Those indications are,
measures, in accordance with the principle of subsidiarity
however, important for people who are intolerant to
as set out in Article 5 of the Treaty on European Union.
lactose. Regulation (EU) No 1169/2011 sets out rules
In accordance with the principle of proportionality, as set
on information to be provided concerning substances
out in that Article, this Regulation does not go beyond
with a scientifically proven allergenic or intolerant
what is necessary in order to achieve those objectives.
effect, to enable consumers, such as lactose-intolerant
people, to make informed choices which are safe for
them. For the sake of clarity and consistency, the estab
lishment of rules on the use of statements indicating the
absence or reduced presence of lactose in food should be
regulated under Regulation (EU) No 1169/2011, taking
(46) Directive
92/52/EEC
provides
that
infant
formulae
and
into account the Scientific Opinion of the Authority of
follow-on formulae exported or re-exported from the
10 September 2010 on lactose thresholds in lactose
Union are to comply with Union law unless otherwise
intolerance and galactosaemia.
requested or stipulated by provisions established by the
importing country. That principle has already been estab
lished for food in Regulation (EC) No 178/2002. For the
sake of simplification and legal certainty, Directive
92/52/EEC should therefore be repealed.
(43) ‘Meal
replacement
for
weight
control’
intended
to
replace
part of the daily diet is considered as food for particular
nutritional uses and is currently governed by specific
rules under Directive 96/8/EC. However, more and
more foods intended for the general population have
(47) Directives 96/8/EC, 1999/21/EC, 2006/125/EC,
appeared on the market carrying similar statements
2006/141/EC, 2009/39/EC and Regulations (EC) No
which are presented as health claims for weight
41/2009 and (EC) No 953/2009 should also be repealed.
control. In order to eliminate any potential confusion
within this group of foods marketed for weight control
and in the interests of legal certainty and coherence of
Union legal acts, such statements should be regulated
solely under Regulation (EC) No 1924/2006 and
comply with requirements set out in that Regulation. It
is necessary that technical adaptations made pursuant to
(48) Adequate
transitional
measures
are
necessary
to
enable
Regulation (EC) No 1924/2006, relating to health claims
food business operators to adapt to the requirements of
referring to control of body weight and made in respect
this Regulation,

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29.6.2013
HAVE ADOPTED THIS REGULATION:
(b) ‘young child’ means a child aged between one and three
years;
CHAPTER I
(c) ‘infant formula’ means food intended for use by infants
GENERAL PROVISIONS
during the first months of life and satisfying by itself the
nutritional requirements of such infants until the intro
Article 1
duction of appropriate complementary feeding;
Subject matter
1. This
Regulation
establishes
compositional
and
information (d) ‘follow-on formula’ means food intended for use by infants
requirements for the following categories of food:
when appropriate complementary feeding is introduced and
which constitutes the principal liquid element in a
progressively diversified diet of such infants;
(a) infant formula and follow-on formula;
(e) ‘processed cereal-based food’ means food:
(b) processed cereal-based food and baby food;
(i) intended to fulfil the particular requirements of infants
in good health while they are being weaned, and of
(c) food for special medical purposes;
young children in good health as a supplement to
their diet and/or for their progressive adaptation, to
ordinary food; and
(d) total diet replacement for weight control.
(ii) pertaining to one of the following categories:
2. This
Regulation
establishes
a
Union
list
of
substances
that
may be added to one or more of the categories of food referred
— simple cereals which are or have to be reconstituted
to in paragraph 1 and lays down the rules applicable to the
with milk or other appropriate nutritious liquids,
updating of that list.
— cereals with an added high protein food which are
or have to be reconstituted with water or other
Article 2
protein-free liquid,
Definitions
1. For the purposes of this Regulation, the following defi
— pastas which are to be used after cooking in boiling
nitions shall apply:
water or other appropriate liquids,
(a) the definitions of ‘food’, ‘food business operator’, ‘retail’ and
— rusks and biscuits which are to be used either
‘placing on the market’ set out respectively in Article 2 and
directly or, after pulverisation, with the addition of
points (3), (7) and (8) of Article 3 of Regulation (EC) No
water, milk or other suitable liquids;
178/2002;
(f) ‘baby food’ means food intended to fulfil the particular
requirements of infants in good health while they are
(b) the definitions of ‘prepacked food’, ‘labelling’ and
being weaned, and of young children in good health as a
‘engineered nanomaterial’ set out respectively in points (e),
supplement to their diet and/or for their progressive adap
(j) and (t) of Article 2(2) of Regulation (EU) No 1169/2011;
tation to ordinary food, excluding:
(c) the definitions of ‘nutrition claim’ and ‘health claim’ set out
(i) processed cereal-based food; and
respectively in points (4) and (5) of Article 2(2) of Regu
lation (EC) No 1924/2006.
(ii) milk-based drinks and similar products intended for
young children;
2. The following definitions shall also apply:
(g) ‘food for special medical purposes’ means food specially
processed or formulated and intended for the dietary
(a) ‘infant’ means a child under the age of 12 months;
management of patients, including infants, to be used

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29.6.2013 Official
Journal
of
the
European
Union L
181/43
under medical supervision; it is intended for the exclusive or
this Regulation is intended, the precautionary principle as set
partial feeding of patients with a limited, impaired or
out in Article 7 of Regulation (EC) No 178/2002 shall apply.
disturbed capacity to take, digest, absorb, metabolise or
excrete ordinary food or certain nutrients contained
therein, or metabolites, or with other medically-determined
nutrient requirements, whose dietary management cannot
CHAPTER II
be achieved by modification of the normal diet alone;
COMPOSITIONAL AND INFORMATION REQUIREMENTS
SECTION 1
(h) ‘total diet replacement for weight control’ means food
General requirements
specially formulated for use in energy restricted diets for
weight reduction which, when used as instructed by the
Article 6
food business operator, replaces the whole daily diet.
General provisions
1. Food
referred
to
in
Article
1(1)
shall
comply
with
any
requirement of Union law applicable to food.
Article 3
Interpretation decisions
In order to ensure the uniform implementation of this Regu
2. The
requirements
laid
down
in
this
Regulation
shall
lation, the Commission may decide, by means of implementing
prevail over any conflicting requirement of Union law
acts:
applicable to food.
(a) whether a given food falls within the scope of this Regu
Article 7
lation;
Opinions of the Authority
The Authority shall provide scientific opinions in accordance
with Articles 22 and 23 of Regulation (EC) No 178/2002 for
(b) to which specific category of food referred to in Article 1(1)
the purpose of the application of this Regulation. Those
a given food belongs.
opinions shall serve as the scientific basis for any Union
measure adopted pursuant to this Regulation which is likely
to have an effect on public health.
Those implementing acts shall be adopted in accordance with
the examination procedure referred to in Article 17(2).
Article 8
Access to documents
Article 4
The Commission shall apply Regulation (EC) No 1049/2001 of
Placing on the market
the European Parliament and of the Council of 30 May 2001
regarding public access to European Parliament, Council and
1. Food
referred
to
in
Article
1(1)
may
only
be
placed
on
the Commission documents (
market if it complies with this Regulation.

1 ) to applications for access to any
document covered by this Regulation.
2. Food
referred
to
in
Article
1(1)
shall
only
be
allowed
on
the retail market in the form of prepacked food.
Article 9
General compositional and information requirements
1. The
composition
of
food
referred
to
in
Article
1(1)
shall
3. Member
States
may
not
restrict
or
forbid
the
placing
on be such that it is appropriate for satisfying the nutritional
the market of food which complies with this Regulation, for
requirements of, and is suitable for, the persons for whom it
reasons related to its composition, manufacture, presentation or
is intended, in accordance with generally accepted scientific
labelling.
data.
Article 5
2. Food
referred
to
in
Article
1(1)
shall
not
contain
any
substance in such quantity as to endanger the health of the
Precautionary principle
persons for whom it is intended.
In order to ensure a high level of health protection in relation
to the persons for whom the food referred to in Article 1(1) of
( 1 ) OJ L 145, 31.5.2001, p. 43.

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29.6.2013
For substances which are engineered nanomaterials, compliance
SECTION 2
with the requirement referred to in the first subparagraph shall
be demonstrated on the basis of adequate test methods, where
Specific requirements
appropriate.
Article 11
Specific compositional and information requirements
1. Subject
to
the
general
requirements
set
out
in
Articles
6
3. On
the
basis
of
generally
accepted
scientific
data, and 9, to the additional requirements of Article 10, and taking
substances added to food referred to in Article 1(1) for the
into account relevant technical and scientific progress, the
purposes of the requirements under paragraph 1 of this
Commission shall be empowered to adopt delegated acts in
Article shall be bio-available for use by the human body,
accordance with Article 18, with respect to the following:
have a nutritional or physiological effect and be suitable for
the persons for whom the food is intended.
(a) the specific compositional requirements applicable to food
referred to in Article 1(1), with the exception of
4. Without
prejudice
to
Article
4(1)
of
this
Regulation,
food
requirements as set out in the Annex;
referred to in Article 1(1) of this Regulation may contain
substances covered by Article 1 of Regulation (EC) No
258/97, provided that those substances fulfil the conditions
under that Regulation for being placed on the market.
(b) the specific requirements on the use of pesticides in
products intended for the production of food referred to
in Article 1(1) and on pesticide residues in such food. The
specific requirements for the categories of food referred to
in points (a) and (b) of Article 1(1) and food for special
5. The
labelling,
presentation
and
advertising
of
food
referred
medical purposes developed to satisfy the nutritional
to in Article 1(1) shall provide information for the appropriate
requirements of infants and young children shall be
use of such food, and shall not mislead, or attribute to such
updated regularly and include, inter alia, provisions to
food the property of preventing, treating or curing a human
restrict the use of pesticides as much as possible;
disease, or imply such properties.
(c) the specific requirements on labelling, presentation and
6. Paragraph
5
shall
not
prevent
the
dissemination
of
any
advertising of food referred to in Article 1(1), including
useful information or recommendations exclusively intended for
the authorisation of nutrition and health claims in relation
persons having qualifications in medicine, nutrition, pharmacy,
thereto;
or for other healthcare professionals responsible for maternal
care and childcare.
(d) the notification requirements for the placing on the market
of food referred to in Article 1(1), in order to facilitate the
Article 10
efficient official monitoring of such food, and on the basis
of which food business operators shall notify the competent
Additional requirements for infant formula and follow-on
authorities of Member States where that food is being
formula
marketed;
1. The
labelling,
presentation
and
advertising
of
infant
formula and follow-on formula shall be designed so as not to
discourage breast-feeding.
(e) the requirements concerning promotional and commercial
practices relating to infant formula;
2. The
labelling,
presentation
and
advertising
of
infant
formula, and the labelling of follow-on formula shall not
include pictures of infants, or other pictures or text which
(f) the requirements concerning information to be provided in
may idealise the use of such formulae.
relation to infant and young child feeding in order to ensure
adequate information on appropriate feeding practices;
Without prejudice to the first subparagraph, graphic represen
tations for easy identification of infant formula and follow-on
(g) the specific requirements for food for special medical
formula and for illustrating methods of preparation shall be
purposes developed to satisfy the nutritional requirements
permitted.
of infants, including compositional requirements and

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European
Union L
181/45
requirements on the use of pesticides in products intended
CHAPTER III
for the production of such food, pesticide residues, labelling,
presentation, advertising, and promotional and commercial
UNION LIST
practices, as appropriate.
Article 15
Union list
1. Substances
belonging
to
the
following
categories
of
These delegated acts shall be adopted by 20 July 2015.
substances may be added to one or more of the categories of
food referred to in Article 1(1), provided that these substances
are included in the Union list set out in the Annex and comply
with the elements contained in the Union list in accordance
2. Subject to the general requirements set out in Articles 6
with paragraph 3 of this Article:
and 9, to the additional requirements of Article 10, and taking
into account relevant technical and scientific progress, including
data provided by interested parties in relation to innovative
(a) vitamins;
products, the Commission shall be empowered to adopt
delegated acts in accordance with Article 18 in order to
update the acts referred to in paragraph 1 of this Article.
(b) minerals;
(c) amino acids;
Where in the case of emerging health risks, imperative grounds
of urgency so require, the procedure provided for in Article 19
shall apply to delegated acts adopted pursuant to this paragraph.
(d) carnitine and taurine;
(e) nucleotides;
Article 12
Milk-based drinks and similar products intended for young
children
(f) choline and inositol.
By 20 July 2015, the Commission shall, after consulting the
Authority, present to the European Parliament and to the
Council a report on the necessity, if any, of special provisions
2. Substances
that
are
included
in
the
Union
list
shall
meet
for milk-based drinks and similar products intended for young
the general requirements set out in Articles 6 and 9 and, where
children regarding compositional and labelling requirements
applicable, the specific requirements established in accordance
and, if appropriate, other types of requirements. The
with Article 11.
Commission shall consider in the report, inter alia, the nutri
tional requirements of young children, the role of those
products in the diet of young children and whether those
3. The
Union
list
shall
contain
the
following
elements:
products have any nutritional benefits when compared to a
normal diet for a child who is being weaned. Such a report
may, if necessary, be accompanied by an appropriate legislative
(a) the category of food referred to in Article 1(1) to which
proposal.
substances belonging to the categories of substances listed
in paragraph 1 of this Article may be added;
Article 13
(b) the name, the description of the substance and, where
appropriate, the specification of its form;
Food intended for sportspeople
By 20 July 2015, the Commission shall, after consulting the
Authority, present to the European Parliament and to the
(c) where appropriate, the conditions of use of the substance;
Council a report on the necessity, if any, of provisions for
food intended for sportspeople. Such a report may, if necessary,
be accompanied by an appropriate legislative proposal.
(d) where appropriate, the purity criteria applicable to the
substance.
Article 14
4. Purity
criteria
established
by
Union
law
applicable
to
food,
Technical guidelines
which apply to the substances included in the Union list when
they are used in the manufacture of food for purposes other
The Commission may adopt technical guidelines to facilitate
than those covered by this Regulation, shall also apply to those
compliance by food business operators, in particular SMEs,
substances when they are used for purposes covered by this
with this Chapter and Chapter III.
Regulation unless otherwise specified in this Regulation.

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L 181/46
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Official Journal of the European Union
29.6.2013
5. For
substances
included
in
the
Union
list
for
which
purity by Regulation (EC) No 178/2002. That committee shall be a
criteria are not established by Union law applicable to food,
committee within the meaning of Regulation (EU) No
generally acceptable purity criteria recommended by inter
182/2011.
national bodies shall apply until the establishment of such
criteria.
2. Where
reference
is
made
to
this
paragraph,
Article
5
of
Member States may maintain national rules setting stricter
Regulation (EU) No 182/2011 shall apply.
purity criteria.
6. In
order
to
take
into
account
technical
progress,
scientific
developments or the protection of consumers’ health, the
Where the opinion of the committee is to be obtained by
Commission shall be empowered to adopt, in relation to the
written procedure, that procedure shall be terminated without
categories of substances listed in paragraph 1 of this Article,
result when, within the time-limit for delivery of the opinion,
delegated acts in accordance with Article 18 with respect to the
the chair of the committee so decides or a simple majority of
following:
committee members so request.
(a) the removal of a category of substances;
Article 18
(b) the addition of a category of substances that have a nutri
Exercise of the delegation
tional or physiological effect.
1. The
power
to
adopt
delegated
acts
is
conferred
on
the
Commission subject to the conditions laid down in this Article.
7. Substances
belonging
to
categories
not
listed
in
paragraph
1 of this Article may be added to food referred to in Article 1(1),
provided that they satisfy the general requirements set out in
Articles 6 and 9 and, where applicable, the specific requirements
2. The power to adopt delegated acts referred to in
established in accordance with Article 11.
Article 11, Article 15(6) and Article 16(1) shall be conferred
on the Commission for a period of five years from 19 July
2013. The Commission shall draw up a report in respect of
Article 16
the delegation of power not later than nine months before the
end of the five-year period. The delegation of power shall be
Updating the Union list
tacitly extended for periods of an identical duration, unless the
1. Subject to the general requirements set out in Articles 6
European Parliament or the Council opposes such extension not
and 9 and, where applicable, the specific requirements estab
later than three months before the end of each period.
lished in accordance with Article 11, and in order to take into
account technical progress, scientific developments or the
protection of consumers’ health, the Commission shall be
empowered to adopt delegated acts in accordance with
3. The
delegation
of
power
referred
to
in
Article
11,
Article 18, to amend the Annex, with respect to the following:
Article 15(6) and Article 16(1) may be revoked at any time
by the European Parliament or by the Council. A decision to
revoke shall put an end to the delegation of the power specified
(a) the addition of a substance to the Union list;
in that decision. It shall take effect the day following the
publication of the decision in the Official Journal of the
(b) the removal of a substance from the Union list;
European Union or at a later date specified therein. It shall not
affect the validity of any delegated acts already in force.
(c) the addition, removal or amendment of the elements
referred to in Article 15(3).
4. As
soon
as
it
adopts
a
delegated
act,
the
Commission
shall
notify it simultaneously to the European Parliament and to the
2. Where,
in
the
case
of
emerging
health
risks,
imperative Council.
grounds of urgency so require, the procedure provided for in
Article 19 shall apply to delegated acts adopted pursuant to this
Article.
5. A delegated act adopted pursuant to Article 11,
Article 15(6) and Article 16(1) shall enter into force only if
CHAPTER IV
no objection has been expressed either by the European
PROCEDURAL PROVISIONS
Parliament or the Council within a period of two months of
notification of that act to the European Parliament and the
Article 17
Council or if, before the expiry of that period, the European
Committee procedure
Parliament and the Council have both informed the
Commission that they will not object. That period shall be
1. The
Commission
shall
be
assisted
by
the
Standing extended by two months at the initiative of the European
Committee on the Food Chain and Animal Health established
Parliament or of the Council.

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Union L
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Article 19
Article 21
Urgency procedure
Transitional measures
1. Delegated
acts
adopted
under
this
Article
shall
enter
into
1. Food
referred
to
in
Article
1(1)
of
this
Regulation
which
force without delay and shall apply as long as no objection is
does not comply with this Regulation but complies with
expressed in accordance with paragraph 2. The notification of a
Directive 2009/39/EC, and, as applicable, with Regulation (EC)
delegated act to the European Parliament and to the Council
No 953/2009 and Directives 96/8/EC, 1999/21/EC,
shall state the reasons for the use of the urgency procedure.
2006/125/EC and 2006/141/EC, and which is placed on the
market or labelled before 20 July 2016 may continue to be
marketed after that date until stocks of such food are exhausted.
2. Either the European Parliament or the Council may object
to a delegated act in accordance with the procedure referred to
Where the date of application of the delegated acts referred to
in Article 18(5). In such a case, the Commission shall repeal the
in Article 11(1) of this Regulation is after 20 July 2016, food
act without delay following the notification of the decision to
referred to in Article 1(1) which complies with this Regulation
object by the European Parliament or by the Council.
and, as applicable, with Regulation (EC) No 953/2009 and
Directives 96/8/EC, 1999/21/EC, 2006/125/EC and
2006/141/EC but does not comply with those delegated acts,
CHAPTER V
and which is placed on the market or labelled before the date of
FINAL PROVISIONS
application of those delegated acts, may continue to be
marketed after that date until stocks of such food are exhausted.
Article 20
Repeal
2. Food
which
is
not
referred
to
in
Article
1(1)
of
this
Regulation but which is placed on the market or labelled in
1. Directive
2009/39/EC
is
repealed
with
effect
from
20
July accordance with Directive 2009/39/EC and Regulation (EC) No
2016. References to the repealed act shall be construed as
953/2009, and, as applicable, with Directive 96/8/EC and Regu
references to this Regulation.
lation (EC) No 41/2009 before 20 July 2016 may continue to
be marketed after that date until stocks of such food are
exhausted.
2. Directive
92/52/EEC
and
Regulation
(EC)
No
41/2009
are
repealed with effect from 20 July 2016.
Article 22
Entry into force
3. Without
prejudice
to
the
first
subparagraph
of
paragraph
4, Directive 96/8/EC shall not apply from 20 July 2016 to
This Regulation shall enter into force on the twentieth day
foods presented as a replacement for one or more meals of
following that of its publication in the Official Journal of the
the daily diet.
European Union.
It shall apply from 20 July 2016, with the exception of the
4. Regulation
(EC)
No
953/2009
and
Directives
96/8/EC, following:
1999/21/EC, 2006/125/EC and 2006/141/EC are repealed
from the date of application of the delegated acts referred to
in Article 11(1).
— Articles 11, 16, 18 and 19 which shall apply from 19 July
2013.
In the case of conflict between Regulation (EC) No 953/2009,
— Article 15 and the Annex to this Regulation which shall
Directives 96/8/EC, 1999/21/EC, 2006/125/EC, 2006/141/EC
apply from the date of application of the delegated acts
and this Regulation, this Regulation shall prevail.
referred to in Article 11(1).
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 12 June 2013.
For the European Parliament
For the Council
The President
The President
M. SCHULZ
L. CREIGHTON

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L 181/48
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Official Journal of the European Union
29.6.2013
ANNEX
Union list as referred to in Article 15(1)
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
Vitamins
Vitamin A
retinol
X
X
X
X
retinyl acetate
X
X
X
X
retinyl palmitate
X
X
X
X
beta-carotene
X
X
X
Vitamin D
ergocalciferol
X
X
X
X
cholecalciferol
X
X
X
X
Vitamin E
D-alpha tocop
X
X
X
X
herol
DL-alpha tocop
X
X
X
X
herol
D-alpha
X
X
X
X
tocopheryl
acetate
DL-alpha
X
X
X
X
tocopheryl
acetate
D-alpha-
X
X
tocopheryl acid
succinate
D-alpha-
X
tocopheryl poly
ethylene glycol-
1000 succinate
(TPGS)
Vitamin K
phylloquinone
X
X
X
X
(phytomena
dione)
Menaquinone ( 1 )
X
X
Vitamin C
L-ascorbic acid
X
X
X
X
sodium-L-
X
X
X
X
ascorbate
calcium-L-
X
X
X
X
ascorbate
potassium-L-
X
X
X
X
ascorbate
L-ascorbyl 6-
X
X
X
X
palmitate

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European
Union L
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Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
Thiamin
thiamin hydro
X
X
X
X
chloride
thiamin mononi
X
X
X
X
trate
Riboflavin
riboflavin
X
X
X
X
riboflavin 5’-
X
X
X
X
phosphate,
sodium
Niacin
nicotinic acid
X
X
X
X
nicotinamide
X
X
X
X
Vitamin B 6
pyridoxine
X
X
X
X
hydrochloride
pyridoxine 5’-
X
X
X
X
phosphate
pyridoxine
X
X
X
dipalmitate
Folate
folic acid (pte
X
X
X
X
roylmono
glutamic acid)
calcium-L-methyl
X
X
folate
Vitamin B 12
cyanocobalamin
X
X
X
X
hydroxoco
X
X
X
X
balamin
Biotin
D-biotin
X
X
X
X
Pantothenic
Acid
D-pantothenate,
X
X
X
X
calcium
D-pantothenate,
X
X
X
X
sodium
dexpanthenol
X
X
X
X
Minerals
Potassium
potassium bicar
X
X
X
bonate
potassium
X
X
X
carbonate

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L 181/50
EN
Official Journal of the European Union
29.6.2013
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
potassium
X
X
X
X
chloride
potassium citrate
X
X
X
X
potassium
X
X
X
X
gluconate
potassium glyce
X
X
X
rophosphate
potassium lactate
X
X
X
X
potassium
X
X
X
hydroxide
potassium salts of
X
X
X
orthophosphoric
acid
magnesium
X
X
potassium citrate
Calcium
calcium
X
X
X
X
carbonate
calcium chloride
X
X
X
X
calcium salts of
X
X
X
X
citric acid
calcium gluconate
X
X
X
X
calcium glycerop
X
X
X
X
hosphate
calcium lactate
X
X
X
X
calcium salts of
X
X
X
X
orthophosphoric
acid
calcium
X
X
X
X
hydroxide
calcium oxide
X
X
X
calcium sulphate
X
X
calcium
X
X
bisglycinate
calcium citrate
X
X
malate
calcium malate
X
X
calcium L-
X
X
pidolate

---

EN
29.6.2013 Official
Journal
of
the
European
Union L
181/51
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
Magnesium
magnesium
X
X
acetate
magnesium
X
X
X
X
carbonate
magnesium
X
X
X
X
chloride
magnesium salts
X
X
X
X
of citric acid
magnesium
X
X
X
X
gluconate
magnesium
X
X
X
glycerophosphate
magnesium salts
X
X
X
X
of orthophos
phoric acid
magnesium
X
X
X
lactate
magnesium
X
X
X
X
hydroxide
magnesium oxide
X
X
X
X
magnesium
X
X
X
X
sulphate
magnesium L-
X
aspartate
magnesium
X
X
bisglycinate
magnesium L-
X
X
pidolate
magnesium
X
X
potassium citrate
Iron
ferrous carbonate
X
X
X
ferrous citrate
X
X
X
X
ferric ammonium
X
X
X
X
citrate
ferrous gluconate
X
X
X
X
ferrous fumarate
X
X
X
X
ferric sodium
X
X
X
diphosphate
ferrous lactate
X
X
X
X

---

L 181/52
EN
Official Journal of the European Union
29.6.2013
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
ferrous sulphate
X
X
X
X
ferrous
X
X
ammonium
phosphate
ferric sodium
X
X
EDTA
ferric diphosphate
X
X
X
X
(ferric pyrophos
phate)
ferric saccharate
X
X
X
elemental iron
X
X
X
(carbonyl + elec
trolytic +
hydrogen
reduced)
ferrous
X
X
X
bisglycinate
ferrous L-pidolate
X
X
Zinc
zinc acetate
X
X
X
X
zinc chloride
X
X
X
X
zinc citrate
X
X
X
X
zinc gluconate
X
X
X
X
zinc lactate
X
X
X
X
zinc oxide
X
X
X
X
zinc carbonate
X
X
zinc sulphate
X
X
X
X
zinc bisglycinate
X
X
Copper
cupric carbonate
X
X
X
X
cupric citrate
X
X
X
X
cupric gluconate
X
X
X
X
cupric sulphate
X
X
X
X
copper lysine
X
X
X
X
complex
Manganese
manganese
X
X
X
X
carbonate
manganese
X
X
X
X
chloride

---

EN
29.6.2013 Official
Journal
of
the
European
Union L
181/53
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
manganese citrate
X
X
X
X
manganese
X
X
X
X
gluconate
manganese glyce
X
X
X
rophosphate
manganese
X
X
X
X
sulphate
Fluoride
potassium
X
X
fluoride
sodium fluoride
X
X
Selenium
sodium selenate
X
X
X
sodium hydrogen
X
X
selenite
sodium selenite
X
X
X
selenium enriched
X
X
yeast ( 2 )
Chromium
chromium (III)
X
X
chloride and its
hexahydrate
chromium (III)
X
X
sulphate and its
hexahydrate
chromium
X
X
picolinate
Molybdenum
ammonium
X
X
molybdate
sodium
X
X
molybdate
Iodine
potassium iodide
X
X
X
X
potassium iodate
X
X
X
X
sodium iodide
X
X
X
X
sodium iodate
X
X
X
Sodium
sodium bicar
X
X
X
bonate
sodium carbonate
X
X
X

---

L 181/54
EN
Official Journal of the European Union
29.6.2013
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
sodium chloride
X
X
X
sodium citrate
X
X
X
sodium gluconate
X
X
X
sodium lactate
X
X
X
sodium
X
X
X
hydroxide
sodium salts of
X
X
X
orthophosphoric
acid
Boron
sodium borate
X
X
boric acid
X
X
Amino
acids ( 3 )
L-alanine
—
X
X
L-arginine X X
X
X
and its hydro
and its hydro
chloride
chloride
L-aspartic acid
X
L-citrulline
X
L-cysteine X X
X
X
and its hydro
and its hydro
chloride
chloride
Cystine ( 4 ) X X
X
X
and its hydro
and its hydro
chloride
chloride
L-histidine X X
X
X
and its hydro
and its hydro
chloride
chloride
L-glutamic acid
X
X
L-glutamine
X
X
glycine
X
L-isoleucine X X
X
X
and its hydro
and its hydro
chloride
chloride
L-leucine X
X
X
X
and its hydro
and its hydro
chloride
chloride
L-lysine X
X
X
X
and its hydro
and its hydro
chloride
chloride
L-lysine acetate
X
X
L-methionine
X
X
X
X
L-ornithine
X
X
L-phenylalanine
X
X
X
X
L-proline
X

---

EN
29.6.2013 Official
Journal
of
the
European
Union L
181/55
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
L-threonine
X
X
X
X
L-tryptophan
X
X
X
X
L-tyrosine
X
X
X
X
L-valine
X
X
X
X
L-serine
X
L-arginine-L-
X
aspartate
L-lysine-L-
X
aspartate
L-lysine-L-
X
glutamate
N-acetyl-L-
X
cysteine
N-acetyl-L-
X
methionine
(in products
intended for
persons over 1
year of age)
Carnitine
and taurine
L-carnitine
X
X
X
X
L-carnitine
X
X
X
X
hydrochloride
taurine
X
X
X
L-carnitine-L-
X
X
X
tartrate
Nucleotides
adenosine 5’-
X
X
X
phosphoric acid
(AMP)
sodium salts of
X
X
X
AMP
cytidine 5’-mono
X
X
X
phosphoric acid
(CMP)
sodium salts of
X
X
X
CMP
guanosine 5’-
X
X
X
phosphoric acid
(GMP)
sodium salts of
X
X
X
GMP
inosine 5’-phos
X
X
X
phoric acid (IMP)
sodium salts of
X
X
X
IMP

---

L 181/56
EN
Official Journal of the European Union
29.6.2013
Category of food
Substance
Infant formula
Processed
Total diet
and follow on
cereal-based food Food for special
replacement for
formula
and baby food
medical purposes
weight control
uridine 5’-phos
X
X
X
phoric acid
(UMP)
sodium salts of
X
X
X
UMP
Choline and
inositol
choline
X
X
X
X
choline chloride
X
X
X
X
choline bitartrate
X
X
X
X
choline citrate
X
X
X
X
inositol
X
X
X
X
( 1 ) Menaquinone occurring principally as menaquinone-7 and, to a minor extent, menaquinone-6.
( 2 ) Selenium-enriched yeasts produced by culture in the presence of sodium selenite as selenium source and containing, in the dried form
as marketed, not more than 2,5 mg Se/g. The predominant organic selenium species present in the yeast is selenomethionine (between
60 and 85 % of total extracted selenium in the product). The content of other organic selenium compounds including selenocysteine
must not exceed 10 % of total extracted selenium. Levels of inorganic selenium normally must not exceed 1 % of total extracted
selenium.
( 3 ) For amino acids used in infant formula, follow-on formula, processed cereal-based food and baby food only the hydrochloride
specifically mentioned may be used. For amino acids used in food for special medical purposes and in total diet replacement for
weight control, as far as applicable, also the sodium, potassium, calcium and magnesium salts as well as their hydrochlorides may be
used.
( 4 ) In the case of use in infant formula, follow-on formula, processed cereal-based food and baby food, only the form L-cystine may be
used.

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Document Outline

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