Corrigendum to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods ( OJ L 404, 30.12.2006 )
Date: 2007-01-18
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, consumer information, consumer protection, foodstuff, health policy, labelling, nutrition

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CORRIGENDA

Corrigendum to 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

(Official Journal of the European Union L 404 of 30 December 2006)

Regulation (EC) No 1924/2006 should read as follows:

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

properties to food. This Regulation should complement
the general principles in Directive 2000/13/EC and lay
down specific provisions concerning the use of nutrition
and health claims concerning foods to be delivered as
such to the consumer.

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

(4)

Acting in accordance with the procedure laid down in Article
251 of the Treaty (2),

Whereas:

(1)

(2)

(3)

An increasing number of foods labelled and advertised in
In
the Community bear nutrition and health claims.
order to ensure a high level of protection for consumers
and to facilitate their choice, products put on the market,
including imported products,
and
adequately labelled. A varied and balanced diet is a prere-
quisite for good health and single products have a relative
importance in the context of the total diet.

should be

safe

Differences between national provisions relating to such
foods and
claims may impede the free movement of
create unequal conditions of competition. They thus have
a direct impact on the functioning of the internal market.
It is therefore necessary to adopt Community rules on
the use of nutrition and health claims on foods.

the European Parliament and of

labelling provisions are contained in Directive
General
2000/13/EC of
the
Council of 20 March 2000 on the approximation of the
laws of
the Member States relating to the labelling,
presentation and advertising of foodstuffs (3). Directive
2000/13/EC generally prohibits the use of information
that would mislead the purchaser or attribute medicinal

(5)

(6)

(1) OJ C 110, 30.4.2004, p. 18.
(2) Opinion of the European Parliament of 26 May 2005 (OJ C 117 E,
18.5.2006, p. 187), Council common position of 8 December 2005
(OJ C 80 E, 4.4.2006, p. 43) and Position of the European Parliament of
16 May 2006 (not yet published in the Official
Journal).
Council Decision of 12 October 2006.

(3) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive 2003/

89/EC (OJ L 308, 25.11.2003, p. 15).

This Regulation should apply to all nutrition and health
claims made in commercial communications,
including
inter alia generic advertising of food and promotional
campaigns, such as those supported in whole or in part
by public authorities. It should not apply to claims which
are made in non-commercial communications, such as
dietary guidelines or advice issued by public health autho-
rities and bodies, or non-commercial communications
and information in the press and in scientific publica-
tions. This Regulation should also apply to trade marks
and other brand names which may be construed as nutri-
tion or health claims.

Generic descriptors (denominations) which have tradi-
tionally been used to indicate a particularity of a class of
foods or beverages which could imply an effect on
human health, such as ‘digestive’ or ‘cough drops’, should
be exempted from the application of this Regulation.

Non-beneficial nutrition claims are not covered by the
scope of
this Regulation; Member States intending to
introduce national schemes relating to non-beneficial
nutrition claims should notify such schemes to the
Commission and to other Member States in accordance
with Directive 98/34/EC of the European Parliament and
of the Council of 22 June 1998 laying down a procedure
for the provision of information in the field of technical
standards and regulations and of rules on Information
Society services (4).

(4) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act

of Accession.

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(7)

(8)

(9)

(10)

level

international

the Codex Alimentarius has
At
adopted General Guidelines on Claims in 1991 and
Guidelines for the Use of Nutrition Claims in 1997. An
amendment to the latter has been adopted by the Codex
Alimentarius Commission in 2004. That amendment
concerns the inclusion of health claims in the 1997
Guidelines. Due consideration is given to the definitions
and conditions set in the Codex Guidelines.

The possibility of using the claim ‘low fat’ for spreadable
fats provided for in Council Regulation (EC) No 2991/94
of 5 December 1994 laying down standards for spread-
able fats (1) should be adapted to the provisions of this
Regulation as soon as possible. In the meantime, Regu-
the products it
lation (EC) No 2991/94 applies for
covers.

There is a wide range of nutrients and other substances
including, but not limited to, vitamins, minerals including
trace elements, amino-acids, essential fatty acids, fibre,
various plants and herbal extracts with a nutritional or
physiological effect that might be present in a food and
be the subject of a claim. Therefore, general principles
applicable to all claims made on foods should be estab-
lished in order to ensure a high level of consumer protec-
tion, give the consumer the necessary information to
make choices in full knowledge of the facts, as well as
creating equal conditions of competition for the food
industry.

Foods promoted with claims may be perceived by consu-
mers as having a nutritional, physiological or other
health advantage over similar or other products to which
such nutrients and other substances are not added. This
may encourage consumers
to make choices which
directly influence their total intake of individual nutrients
or other substances in a way which would run counter to
scientific advice. To address this potential undesirable
effect, it is appropriate to impose certain restrictions as
regards the products bearing claims.
In this context,
factors such as the presence of certain substances, or the
nutrient profile of a product, are appropriate criteria for
determining whether the product can bear claims. The
use of such criteria at national level, whilst justified for
the purpose of allowing consumers to make informed
nutritional choices, is likely to result in barriers to intra-
Community trade and should therefore be harmonised at
Community level. Health information and communica-
tion supporting national
authority or Community
messages about the dangers of misuse of alcohol should
not fall under the scope of this Regulation.

(11)

(12)

(13)

(14)

The application of nutrient profiles as a criterion would
aim to avoid a situation where nutrition or health claims
mask the overall nutritional status of a food product,
which could mislead consumers when trying to make
healthy choices in the context of a balanced diet. Nutrient
profiles as provided for in this Regulation should be
intended for the sole purpose of governing the circum-
stances in which claims may be made. They should be
based on generally accepted scientific evidence relative to
the relationship between diet and health. However,
profiles should also allow for product innovation and
should take into account the variability of dietary habits
and traditions, and the fact that individual products may
have an important role in the context of an overall diet.

The establishment of nutrient profiles should take into
account the content of different nutrients and substances
with a nutritional or physiological effect,
in particular
those such as fat, saturated fat, trans-fatty acids, salt/
sodium and sugars, excessive intakes of which in the
overall diet are not recommended, as well as poly- and
mono-unsaturated fats, available carbohydrates other
than sugars, vitamins, minerals, protein and fibre. When
setting the nutrient profiles, the different categories of
foods and the place and role of these foods in the overall
diet should be taken into account and due regard should
be given to the various dietary habits and consumption
patterns existing in the Member States. Exemptions from
the requirement to respect established nutrient profiles
may be necessary for certain foods or categories of foods
depending on their role and importance in the diet of the
population. These would be complex technical tasks and
the adoption of
should be
entrusted to the Commission, taking into account the
advice of the European Food Safety Authority.

relevant measures

the

Food supplements as defined in Directive 2002/46/EC of
the European Parliament and of the Council of 10 June
2002 on the approximation of the laws of the Member
States relating to food supplements (2) presented in a
liquid form and containing more than 1,2 % by volume
of alcohol are not considered as beverages under this
Regulation.

There is a wide variety of claims currently used in the
labelling and advertising of foods in some Member States
relating to substances that have not been shown to be
beneficial or for which at present there is not sufficient
scientific agreement. It is necessary to ensure that the
substances for which a claim is made have been shown
to have a beneficial nutritional or physiological effect.

(1) OJ L 316, 9.12.1994, p. 2.

(2) OJ L 183, 12.7.2002, p. 51. Directive as amended by Commission

Directive 2006/37/EC (OJ L 94, 1.4.2006, p. 32).

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(15)

(16)

In order to ensure that the claims made are truthful, it is
necessary that the substance that is the subject of the
claim is present in the final product in quantities that are
sufficient, or that the substance is absent or present in
suitably reduced quantities, to produce the nutritional or
physiological effect claimed. The substance should also be
available to be used by the body. In addition, and where
appropriate, a significant amount of the substance produ-
cing the claimed nutritional or physiological effect should
be provided by a quantity of the food that can reasonably
be expected to be consumed.

of

It is important that claims on foods can be understood
by the consumer and it is appropriate to protect all
consumers from misleading claims. However, since the
enactment
84/450/EEC of
Council Directive
10 September 1984 concerning misleading and compara-
tive advertising (1), the Court of Justice of the European
Communities has found it necessary in adjudicating on
advertising cases to examine the effect on a notional,
typical consumer. In line with the principle of propor-
tionality, and to enable the effective application of the
protective measures contained in it, this Regulation takes
as a benchmark the average consumer, who is reasonably
well-informed and reasonably observant and circumspect,
taking into account social, cultural and linguistic factors,
as interpreted by the Court of Justice, but makes provi-
sion to prevent the exploitation of consumers whose
characteristics make them particularly vulnerable to
misleading claims. Where a claim is specifically aimed at
a particular group of consumers, such as children, it is
desirable that the impact of the claim be assessed from
the perspective of the average member of that group. The
average consumer test is not a statistical test. National
courts and authorities will have to exercise their own
faculty of judgment, having regard to the case-law of the
Court of Justice, to determine the typical reaction of the
average consumer in a given case.

(17)

Scientific substantiation should be the main aspect to be
taken into account for the use of nutrition and health
claims and the food business operators using claims
should justify them. A claim should be scientifically
substantiated by taking into account the totality of the
available scientific data, and by weighing the evidence.

(18) A nutrition or health claim should not be made if it is
inconsistent with generally accepted nutrition and health
principles or
it encourages or condones excessive
consumption of any food or disparages good dietary
practice.

if

(19) Given the positive image conferred on foods bearing
impact
nutrition and health claims and the potential

(1) OJ L 250, 19.9.1984, p. 17. Directive as last amended by Directive
2005/29/EC of the European Parliament and of the Council (OJ L 149,
11.6.2005, p. 22).

these foods may have on dietary habits and overall
nutrient intakes, the consumer should be able to evaluate
their global nutritional quality. Therefore, nutrition label-
ling should be compulsory and should be extensive on
all foods bearing health claims.

(20) General nutritional labelling provisions are contained in
Council Directive 90/496/EEC of 24 September 1990 on
nutrition labelling for foodstuffs (2). According to that
Directive, where a nutrition claim appears on labelling, in
presentation or in advertising, with the exclusion of
generic advertising, nutrition labelling should be compul-
sory. Where a nutrition claim is made for sugars, satu-
rates, fibre or sodium, the information to be given should
be that of Group 2 as defined in Article 4(1) of Directive
90/496/EEC. In order to achieve a high level of consumer
protection, this obligation to provide the information of
Group 2 should apply mutatis mutandis where any
health claim is made, with the exception of generic adver-
tising.

(21) A list of permitted nutrition claims and their specific
conditions of use should also be created based on the
conditions for the use of such claims that have been
agreed at national or international level and laid down in
Community legislation. Any claim considered to have the
same meaning for consumers as a nutrition claim
included in the abovementioned list should be subject to
the same conditions of use indicated therein. For
example, claims related to the addition of vitamins and
minerals such as ‘with …’,
‘added …’, or
‘enriched …’ should be subject to the conditions set for
the claim ‘source of …’. The list should be regularly
updated in order to take into account scientific and tech-
for comparative
nological developments. Furthermore,
claims it is necessary that the products being compared
be clearly identified to the final consumer.

‘restored …’,

(22)

Conditions for claims such as ‘lactose-free’ or ‘gluten-free’,
addressed to a group of consumers with specific disor-
ders,
should be dealt with in Council Directive
89/398/EEC of 3 May 1989 on the approximation of the
laws of the Member States relating to foodstuffs intended
for particular nutritional uses (3). In addition, that Direc-
tive provides the possibility that foodstuffs for normal
consumption can indicate their suitability for use by
these groups of consumers if they fulfil the conditions
for such statement. Until the conditions for such state-
ments are set at Community level, Member States may
maintain or adopt relevant national measures.

(2) OJ L 276, 6.10.1990, p. 40. Directive as last amended by Commission

Directive 2003/120/EC (OJ L 333, 20.12.2003, p. 51).

(3) OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council (OJ
L 284, 31.10.2003, p. 1).

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(23) Health claims should only be authorised for use in the
Community after a scientific assessment of the highest
possible standard. In order to ensure harmonised scien-
tific assessment of
the European Food
these claims,
Safety Authority should carry out such assessments.
Upon request the applicant should be able to have access
to his file to check the state of the procedure.

(24)

(25)

behavioural

There are many factors, other than dietary ones, that can
influence psychological
functions.
and
Communication on these functions is thus very complex
and it is difficult to convey a comprehensive, truthful and
meaningful message in a short claim to be used in the
labelling and advertising of foods. Therefore, it is appro-
priate, when using psychological and behavioural claims,
to require scientific substantiation.

In the light of Commission Directive 96/8/EC of 26
February 1996 on foods intended for use in energy-
restricted diets for weight reduction (1) which prohibits,
in the labelling, presentation and advertising of products
covered by that Directive, any reference to the rate or
amount of weight loss which may result from their use,
it is considered appropriate to extend this restriction to
all foods.

(26) Health claims other than those referring to the reduction
of disease risk and to children's development and health,
based on generally accepted scientific evidence, should
undergo a different type of assessment and authorisation.
It is therefore necessary to adopt a Community list of
such permitted claims after consulting the European
Food Safety Authority. Furthermore, in order to stimulate
innovation,
those health claims which are based on
newly developed scientific evidence should undergo an
accelerated type of authorisation.

(27)

In order to keep up with scientific and technological
developments, the list referred to above should be revised
promptly whenever necessary. Such revisions are imple-
menting measures of a technical nature and their adop-
tion should be entrusted to the Commission in order to
simplify and expedite the procedure.

(28) Diet is one of the many factors influencing the onset of
certain human diseases. Other factors such as age, genetic
predisposition, the level of physical activity, the consump-
tion of tobacco and other drugs, environmental exposure
and stress may all influence the onset of human diseases.
Specific labelling requirements should therefore apply
in respect of claims relating to the reduction of a disease
risk.

(29)

In order to ensure that health claims are truthful, clear,
reliable and useful to the consumer in choosing a healthy

(1) OJ L 55, 6.3.1996, p. 22.

(30)

(31)

(32)

diet, the wording and the presentation of health claims
should be taken into account in the opinion of the Euro-
pean Food Safety Authority and in subsequent proce-
dures.

In some cases, scientific risk assessment alone cannot
provide all the information on which a risk management
decision should be based. Other legitimate factors rele-
vant to the matter under consideration should therefore
be taken into account.

For the sake of
transparency and in order to avoid
multiple applications in respect of claims which have
already been assessed, a public Register containing the
lists of such claims should be established and updated by
the Commission.

In order to stimulate research and development within
it is appropriate to protect the
the agri-food industry,
investment made by innovators in gathering the informa-
tion and data supporting an application under this Regu-
lation. This protection should however be limited in time
in order to avoid the unnecessary repetition of studies
and trials, and to facilitate access to claims by small and
medium-sized enterprises (SMEs), which rarely have the
financial capacity to carry out research activities.

(33)

SMEs represent an important added value to the Euro-
pean food industry in terms of quality and preservation
of different dietary habits. In order to facilitate the imple-
mentation of this Regulation, the European Food Safety
Authority should make available appropriate technical
guidance and tools, in due time, especially for SMEs.

(34) Given the particular nature of foods bearing claims, addi-
tional means to those usually available to monitoring
bodies should be available in order to facilitate efficient
monitoring of those products.

(35) Adequate transitional measures are necessary to enable
food business operators to adapt to the requirements of
this Regulation.

(36)

Since the objective of this Regulation, namely to ensure
the effective functioning of the internal market as regards
nutrition and health claims whilst providing a high level
of consumer protection, cannot be sufficiently achieved
by the Member States and can therefore be better
achieved at Community level, the Community may adopt
measures, in accordance with the principle of subsidiarity
as set out in Article 5 of the Treaty. 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 that objective.

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(37)

The measures necessary for the implementation of this
Regulation should be
adopted in accordance with
Council Decision 1999/468/EC of 28 June 1999 laying
down the procedures for the exercise of implementing
powers conferred on the Commission (1),

which will forward it to the Commission without delay. The
Commission shall adopt and make public the rules for food
business operators according to which such applications shall be
made, so as to ensure that the application is dealt with transpar-
ently and within a reasonable time.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

This Regulation shall apply without prejudice to the

5.
following Community provisions:

(a) Directive 89/398/EEC and Directives adopted relating to

foodstuffs for particular nutritional uses;

(b) Council Directive 80/777/EEC of 15 July 1980 on the
approximation of the laws of the Member States relating to
the exploitation and marketing of natural mineral waters (2);

Article 1

(c) Council Directive 98/83/EC of 3 November 1998 on the

quality of water intended for human consumption (3);

Subject matter and scope

(d) Directive 2002/46/EC.

This Regulation harmonises the provisions laid down by
1.
law, regulation or administrative action in Member States which
relate to nutrition and health claims in order to ensure the effec-
tive functioning of the internal market whilst providing a high
level of consumer protection.

2.
This Regulation shall apply to nutrition and health claims
made in commercial communications, whether in the labelling,
presentation or advertising of foods to be delivered as such to
the final consumer.

In the case of non-prepackaged foodstuffs (including fresh
products such as fruit, vegetables or bread) put up for sale to
the final consumer or to mass caterers and foodstuffs packed at
the point of sale at the request of the purchaser or pre-packaged
with a view to immediate sale, Article 7 and Article 10(2)(a)
and (b) shall not apply. National provisions may apply until the
eventual adoption of Community measures in accordance with
the procedure referred to in Article 25(2).

This Regulation shall also apply in respect of foods intended for
supply to restaurants, hospitals, schools, canteens and similar
mass caterers.

3.
A trade mark, brand name or fancy name appearing in the
labelling, presentation or advertising of a food which may be
construed as a nutrition or health claim may be used without
undergoing the authorisation procedures provided for in this
Regulation, provided that it is accompanied by a related nutri-
tion or health claim in that labelling, presentation or advertising
which complies with the provisions of this Regulation.

4.
For generic descriptors (denominations) which have tradi-
tionally been used to indicate a particularity of a class of foods
or beverages which could imply an effect on human health, a
derogation from paragraph 3 may be adopted in accordance
with the procedure referred to in Article 25(2), on application
by the food business operators concerned. The application shall
be sent to the national competent authority of a Member State

(1) OJ L 184, 17.7.1999, p. 23.

Article 2

Definitions

1.

For the purposes of this Regulation:

(a) the definitions of ‘food’, ‘food business operator’, ‘placing on
the market’, and ‘final consumer’ set out in Articles 2, 3(3),
3(8) and 3(18) of Regulation (EC) No 178/2002 of the
European
of
and
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 (4) shall apply;

Parliament

Council

the

of

(b) the definition of ‘food supplement’ set out in Directive 2002/

46/EC shall apply;

(c) the definitions of

‘sugars’,

drate’,
unsaturates’,
apply;

‘nutrition labelling’,

‘carbohy-
‘poly-
‘fibre’ set out in Directive 90/496/EEC shall

‘mono-unsaturates’,

‘saturates’,

‘protein’,

‘fat’,

(d) the definition of ‘labelling’ set out in Article 1(3)(a) of Direc-

tive 2000/13/EC shall apply.

2.

The following definitions shall also apply:

1) ‘claim’ means any message or representation, which is not
legislation,
mandatory under Community or national
including pictorial, graphic or symbolic representation,
in
any form, which states, suggests or implies that a food has
particular characteristics;

(2) OJ L 229, 30.8.1980, p. 1. Directive as last amended by Regulation (EC)

No 1882/2003.

(3) OJ L 330, 5.12.1998, p. 32. Directive as amended by Regulation (EC)

No 1882/2003.

(4) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

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2) ‘nutrient’ means protein, carbohydrate,

fibre, sodium,
vitamins and minerals listed in the Annex to Directive
90/496/EEC, and substances which belong to or are compo-
nents of one of those categories;

fat,

3) ‘other substance’ means a substance other than a nutrient

that has a nutritional or physiological effect;

4) ‘nutrition claim’ means any claim which states, suggests or
implies that a food has particular beneficial nutritional prop-
erties due to:

(a) the energy (calorific value) it

(i) provides;

(d) state, suggest or imply that a balanced and varied diet
cannot provide appropriate quantities of nutrients
in
general. Derogations in the case of nutrients for which suffi-
cient quantities cannot be provided by a balanced and
varied diet,
including the conditions for their application,
may be adopted in accordance with the procedure referred
to in Article 25(2), taking into account the special condi-
tions present in Member States;

(e) refer to changes in bodily functions which could give rise to
or exploit fear in the consumer, either textually or through
pictorial, graphic or symbolic representations.

(ii) provides at a reduced or increased rate; or

Article 4

(iii) does not provide; and/or

(b) the nutrients or other substances it

(i)

contains;

(ii) contains in reduced or increased proportions; or

(iii) does not contain;

5) ‘health claim’ means any claim that states, suggests or
implies that a relationship exists between a food category, a
food or one of its constituents and health;

6) ‘reduction of disease risk claim’ means any health claim that
states, suggests or implies that the consumption of a food
category, a food or one of
its constituents significantly
reduces a risk factor in the development of a human disease;

7) ‘Authority’ means the European Food Safety Authority estab-

lished by Regulation (EC) No 178/2002.

CHAPTER II

GENERAL PRINCIPLES

Article 3

General principles for all claims

Nutrition and health claims may be used in the labelling, presen-
tation and advertising of foods placed on the market in the
Community only if they comply with the provisions of this
Regulation.

Without prejudice to Directives 2000/13/EC and 84/450/EEC,
the use of nutrition and health claims shall not:

(a) be false, ambiguous or misleading;

Conditions for the use of nutrition and health claims

By 19 January 2009, the Commission shall, in accordance
1.
with the procedure referred to in Article 25(2), establish specific
nutrient profiles, including exemptions, which food or certain
categories of food must comply with in order to bear nutrition
or health claims and the conditions for the use of nutrition or
health claims for foods or categories of foods with respect to
the nutrient profiles.

The nutrient profiles for food and/or certain categories of food
shall be established taking into account in particular:

(a) the quantities of certain nutrients and other substances
contained in the food, such as fat, saturated fatty acids,
trans-fatty acids, sugars and salt/sodium;

(b) the role and importance of the food (or of categories of
food) and the contribution to the diet of the population in
general or, as appropriate, of certain risk groups including
children;

(c) the overall nutritional composition of

the food and the
presence of nutrients that have been scientifically recognised
as having an effect on health.

The nutrient profiles shall be based on scientific knowledge
about diet and nutrition, and their relation to health.

In setting the nutrient profiles, the Commission shall request the
Authority to provide within 12 months relevant scientific
advice, focusing in particular on:

(i) whether profiles should be set for food in general and/or

categories of food;

(b) give rise to doubt about the safety and/or the nutritional

adequacy of other foods;

(ii)

the choice and balance of nutrients to be taken into
account;

(c) encourage or condone excess consumption of a food;

(iii) the choice of reference quantity/basis for profiles;

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(iv) the approach to the calculation of the profiles; and

(v)

the feasibility and testing of a proposed system.

In setting the nutrient profiles, the Commission shall carry out
consultations with interested parties, in particular food business
operators and consumer groups.

(a) the presence, absence or reduced content in a food or cate-
gory of food of a nutrient or other substance in respect of
which the claim is made has been shown to have a benefi-
cial nutritional or physiological effect, as established by
generally accepted scientific evidence;

(b) the nutrient or other substance for which the claim is made:

Nutrient profiles and their conditions of use shall be updated to
take into account relevant scientific developments in accordance
with the procedure referred to in Article 25(2) and after consul-
tation of interested parties, in particular food business operators
and consumer groups.

2.

By way of derogation from paragraph 1, nutrition claims:

(a) referring to the reduction of fat, saturated fatty acids, trans-
fatty acids, sugars and salt/sodium shall be allowed without
reference to a profile for the specific nutrient/s for which
the claim is made, provided they comply with the conditions
laid down in this Regulation;

(b) shall be allowed, where a single nutrient exceeds the nutrient
profile provided that a statement about the specific nutrient
appears in close proximity to, on the same side and with the
same prominence as the claim. This statement shall read as
follows: ‘High [… (*)] content’.

Beverages containing more than 1,2 % by volume of

3.
alcohol shall not bear health claims.

As far as nutrition claims are concerned, only nutrition claims
referring to low alcohol levels, or the reduction of the alcohol
content, or the reduction of the energy content for beverages
containing more than 1,2 % by volume of alcohol, shall be
permitted.

In the absence of specific Community rules regarding
4.
nutrition claims referring to low alcohol levels, or the reduction
or absence of alcohol or energy in beverages which normally
contain alcohol, relevant national rules may apply in compliance
with the provisions of the Treaty.

(i)

is contained in the final product in a significant quantity
as defined in Community legislation or, where such
rules do not exist, in a quantity that will produce the
nutritional or physiological effect claimed as established
by generally accepted scientific evidence; or

(ii) is not present or is present in a reduced quantity that
will produce the nutritional or physiological effect
claimed as established by generally accepted scientific
evidence;

(c) where applicable, the nutrient or other substance for which
the claim is made is in a form that is available to be used by
the body;

(d) the quantity of the product that can reasonably be expected
to be consumed provides a significant quantity of
the
nutrient or other substance to which the claim relates, as
defined in Community legislation or, where such rules do
not exist, a significant quantity that will produce the nutri-
tional or physiological effect claimed as established by
generally accepted scientific evidence;

(e) compliance with the specific conditions set out in Chapter

III or Chapter IV as the case may be.

2.
The use of nutrition and health claims shall only be
permitted if the average consumer can be expected to under-
stand the beneficial effects as expressed in the claim.

Nutrition and health claims shall refer to the food ready
3.
for consumption in accordance with the manufacturer's instruc-
tions.

5.
Foods or categories of foods other than those referred to
in paragraph 3, for which nutrition or health claims are to be
restricted or prohibited, may be determined in accordance with
the procedure referred to in Article 25(2) and in the light of
scientific evidence.

Article 6

Scientific substantiation for claims

Article 5

General conditions

Nutrition and health claims shall be based on and substan-

1.
tiated by generally accepted scientific evidence.

A food business operator making a nutrition or health

2.
claim shall justify the use of the claim.

The use of nutrition and health claims shall only be

1.
permitted if the following conditions are fulfilled:

(*) The name of the nutrient exceeding the nutrient profile.

The competent authorities of

3.
the Member States may
request a food business operator or a person placing a product
on the market to produce all relevant elements and data estab-
lishing compliance with this Regulation.

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Article 7

Nutrition information

The obligation and the modalities for providing information
pursuant to Directive 90/496/EEC where a nutrition claim is
made shall apply mutatis mutandis where a health claim is
made, with the exception of generic advertising. However, the
information in
information to be provided shall consist of
Group 2 as defined in Article 4(1) of Directive 90/496/EEC.

In addition and as the case may be,
the
substance(s) to which a nutrition or health claim relates that
does not appear in the nutrition labelling shall also be stated in
the same field of vision as the nutrition information and be
expressed in accordance with Article 6 of Directive 90/496/EEC.

the amount(s) of

In the case of food supplements, the nutrition information shall
be provided in accordance with Article 8 of Directive
2002/46/EC.

CHAPTER III

NUTRITION CLAIMS

Article 8

Specific conditions

1.
Nutrition claims shall only be permitted if they are listed
in the Annex and are in conformity with the conditions set out
in this Regulation.

2.
Amendments to the Annex shall be adopted in accordance
with the procedure referred to in Article 25(2) and, where
appropriate, after consulting the Authority. Where appropriate,
the Commission shall
in particular
food business operators and consumer groups, in order to eval-
uate the perception and understanding of the claims in ques-
tion.

involve interested parties,

Article 9

Comparative claims

1. Without prejudice to Directive 84/450/EEC, a comparison
may only be made between foods of the same category, taking
into consideration a range of foods of that category. The differ-
ence in the quantity of a nutrient and/or the energy value shall
be stated and the comparison shall relate to the same quantity
of food.

2.
Comparative nutrition claims shall compare the composi-
tion of the food in question with a range of foods of the same
category, which do not have a composition which allows them
to bear a claim, including foods of other brands.

CHAPTER IV

HEALTH CLAIMS

Article 10

Specific conditions

1.
Health claims shall be prohibited unless they comply with
the general requirements in Chapter II and the specific require-
ments in this Chapter and are authorised in accordance with
this Regulation and included in the lists of authorised claims
provided for in Articles 13 and 14.

Health claims shall only be permitted if

the following
2.
information is included in the labelling, or if no such labelling
exists, in the presentation and advertising:

(a) a statement

indicating the importance of a varied and

balanced diet and a healthy lifestyle;

(b) the quantity of

the food and pattern of consumption

required to obtain the claimed beneficial effect;

(c) where appropriate, a statement addressed to persons who

should avoid using the food; and

(d) an appropriate warning for products that are likely to

present a health risk if consumed to excess.

3.
Reference to general, non-specific benefits of the nutrient
or food for overall good health or health-related well-being may
only be made if accompanied by a specific health claim included
in the lists provided for in Article 13 or 14.

4. Where appropriate, guidelines on the implementation of
this Article shall be adopted in accordance with the procedure
referred to in Article 25(2) and,
in consultation
with interested parties, in particular food business operators and
consumer groups.

if necessary,

Article 11

National associations of medical, nutrition or dietetic
professionals and health-related charities

In the absence of specific Community rules concerning recom-
mendations of or endorsements by national associations of
medical, nutrition or dietetic professionals and health-related
charities, relevant national rules may apply in compliance with
the provisions of the Treaty.

Article 12

Restrictions on the use of certain health claims

The following health claims shall not be allowed:

(a) claims which suggest that health could be affected by not

consuming the food;

(b) claims which make reference to the rate or amount of

weight loss;

(c) claims which make reference to recommendations of indivi-
dual doctors or health professionals and other associations
not referred to in Article 11.

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Article 13

Community list of such permitted claims together with all the
necessary conditions for the use of these claims.

Health claims other than those referring to the reduction
of disease risk and to children's development and health

1.

Health claims describing or referring to:

(a) the role of a nutrient or other substance in growth, develop-

ment and the functions of the body; or

(b) psychological and behavioural functions; or

(c) without prejudice to Directive 96/8/EC, slimming or weight-
control or a reduction in the sense of hunger or an increase
in the sense of satiety or to the reduction of the available
energy from the diet,

which are indicated in the list provided for in paragraph 3 may
be made without undergoing the procedures laid down in Arti-
cles 15 to 19, if they are:

(i) based on generally accepted scientific evidence; and

(ii) well understood by the average consumer.

2. Member States shall provide the Commission with lists of
claims as referred to in paragraph 1 by 31 January 2008 at the
latest accompanied by the conditions applying to them and by
references to the relevant scientific justification.

After consulting the Authority,

the Commission shall
3.
adopt, in accordance with the procedure referred to in Article
25(2), a Community list of permitted claims as referred to in
paragraph 1, and all necessary conditions for the use of these
claims by. 31 January 2010 at the latest.

4.
Any changes to the list referred to in paragraph 3, based
on generally accepted scientific evidence, shall be adopted in
accordance with the procedure referred to in Article 25(2), after
consulting the Authority, on the Commission's own initiative or
following a request by a Member State.

5.
Any additions of claims to the list referred to in paragraph
3 based on newly developed scientific evidence and/or which
include a request for the protection of proprietary data shall be
adopted following the procedure laid down in Article 18, except
claims referring to children's development and health, which
shall be authorised in accordance with the procedure laid down
in Articles 15, 16, 17 and 19.

Article 14

Reduction of disease risk claims and claims referring to
children's development and health

1.
Notwithstanding Article 2(1)(b) of Directive 2000/13/EC,
reduction of disease risk claims and claims referring to children's
development and health may be made where they have been
authorised in accordance with the procedure laid down in Arti-
cles 15, 16, 17 and 19 of this Regulation for inclusion in a

2.
In addition to the general requirements laid down in this
Regulation and the specific requirements of paragraph 1, for
reduction of disease risk claims the labelling or, if no such label-
ling exists, the presentation or advertising shall also bear a state-
ment indicating that the disease to which the claim is referring
has multiple risk factors and that altering one of these risk
factors may or may not have a beneficial effect.

Article 15

Application for authorisation

1. When reference is made to this Article, an application for
authorisation shall be submitted in accordance with the
following paragraphs.

The application shall be sent to the national competent

2.
authority of a Member State.

(a) The national competent authority shall:

(i)

acknowledge receipt of an application in writing within
14 days of its receipt. The acknowledgement shall state
the date of receipt of the application;

(ii)

inform without delay the Authority; and

(iii) make the application and any supplementary informa-
to the

applicant

available

tion supplied by the
Authority;

(b) The Authority shall:

(i)

inform without delay the other Member States and the
Commission of the application and shall make the appli-
cation and any supplementary information supplied by
the applicant available to them;

(ii) make the summary of

the application referred to in

paragraph 3(g) available to the public.

3.

The application shall include the following:

(a) the name and address of the applicant;

(b) the nutrient or other substance, or the food or the category
of food, in respect of which the health claim is to be made
and its particular characteristics;

(c) a copy of the studies, including, where available, indepen-
dent, peer-reviewed studies, which have been carried out
with regard to the health claim and any other material
the health claim
which is available to demonstrate that
complies with the criteria provided for in this Regulation;

(d) where appropriate, an indication of the information which
should be regarded as proprietary accompanied by verifiable
justification;

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(e) a copy of other scientific studies which are relevant to that

health claim;

reasons for
opinion was based.

its opinion and the information on which its

(f) a proposal for the wording of the health claim for which
including, as the case may be,

authorisation is sought
specific conditions for use;

The Authority, in accordance with Article 38(1) of Regu-

6.
lation (EC) No 178/2002, shall make its opinion public.

(g) a summary of the application.

4.
The Commission, having first consulted the Authority,
shall establish in accordance with the procedure referred to in
Article 25(2)
this
Article, including rules concerning the preparation and presenta-
tion of the application.

implementing rules for the application of

5.
The Commission, in close cooperation with the Authority,
shall make available appropriate technical guidance and tools to
assist
in the
preparation and presentation of the application for scientific
assessment.

food business operators,

in particular SMEs,

Article 16

Opinion of the Authority

In giving its opinion, the Authority shall respect a time
1.
limit of five months from the date of receipt of a valid applica-
tion. Whenever the Authority seeks supplementary information
from the applicant as provided for in paragraph 2, such time
limit shall be extended by up to two months following the date
of receipt of the requested information submitted by the appli-
cant.

2.
The Authority or a national competent authority through
the Authority may, where appropriate, request the applicant to
supplement the particulars accompanying the application within
a specified time limit.

3.

In order to prepare its opinion, the Authority shall verify:

(a) that the health claim is substantiated by scientific evidence;

(b) that the wording of the health claim complies with the

criteria laid down in this Regulation.

4.
In the event of an opinion in favour of authorising the
health claim, the opinion shall include the following particulars:

(a) the name and address of the applicant;

(b) the nutrient or other substance, or the food or the category
of food, in respect of which a claim is to be made and its
particular characteristics;

(c) a proposal for the wording of the health claim, including, as

the case may be, the specific conditions of use;

The applicant or members of the public may make comments
to the Commission within 30 days from such publication.

Article 17

Community authorisation

the Commission shall submit

1. Within two months after receiving the opinion of the
Authority,
to the Committee
referred to in Article 23(2) a draft decision on the lists of
permitted health claims, taking into account the opinion of the
Authority, any relevant provisions of Community law and other
legitimate factors relevant to the matter under consideration.
Where the draft decision is not in accordance with the opinion
of the Authority, the Commission shall provide an explanation
for the differences.

Any draft decision to amend the lists of permitted health

2.
claims shall include the particulars referred to in Article 16(4).

A final decision on the application shall be adopted in

3.
accordance with the procedure referred to in Article 25(2).

4.
The Commission shall without delay inform the applicant
of the decision taken and publish details of the decision in the
Official Journal of the European Union.

Health claims included in the lists provided for in Articles
5.
13 and 14 may be used,
in conformity with the conditions
applying to them, by any food business operator, if they are not
restricted for use
in accordance with the provisions of
Article 21.

The granting of authorisation shall not lessen the general
liability of any food business operator in

6.
civil and criminal
respect of the food concerned.

Article 18

Claims referred to in Article 13(5)

A food business operator intending to use a health claim
1.
not included in the list provided for in Article 13(3) may apply
for the inclusion of the claim in that list.

(d) where applicable, conditions or restrictions of use of the
food and/or an additional statement or warning that should
accompany the health claim on the label and in advertising.

5.
The Authority shall forward its opinion to the Commis-
sion, the Member States and the applicant, including a report
describing its assessment of the health claim and stating the

The application for this inclusion shall be submitted to the
2.
national competent authority of a Member State which shall
acknowledge receipt of
the application in writing within
14 days of its receipt. The acknowledgement shall state the date
of receipt of the application. The application shall include the
data provided for in Article 15(3) and the reasons for the
request.

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The valid application, in line with the guidance referred to
3.
in Article 15(5), and any information supplied by the applicant
shall be sent without delay to the Authority for a scientific
assessment as well as to the Commission and the Member States
for information. The Authority shall issue its opinion within a
the
time limit of
request. Such time limit may be extended by up to one month if
the Authority considers it necessary to seek supplementary
information from the applicant. In such a case the applicant
shall submit the requested information within 15 days from the
date of receipt of the Authority's request.

five months from the date of receipt of

CHAPTER V

GENERAL AND FINAL PROVISIONS

Article 20

Community Register

The Commission shall establish and maintain a Com-
1.
munity Register of nutrition and health claims made on food,
hereinafter referred to as ‘the Register’.

The procedure laid down in Article 16(3)(a) and (b), (5) and (6)
shall apply mutatis mutandis.

2.

The Register shall include the following:

4. Where the Authority,
following scientific assessment,
issues an opinion in favour of the inclusion of the claim in the
list provided for in Article 13(3), the Commission shall take a
decision on the application, taking into account the opinion of
the Authority, any relevant provisions of Community law and
other legitimate factors relevant to the matter under considera-
tion, after having consulted the Member States and within two
months of receiving the opinion of the Authority.

Where the Authority issues an opinion that does not support
the inclusion of the claim in that list, a decision on the applica-
tion shall be taken in accordance with the procedure referred to
in Article 25(2).

Article 19

(a) the nutrition claims and the conditions applying to them as

set out in the Annex;

(b) restrictions adopted in accordance with Article 4(5);

(c) the authorised health claims and the conditions applying to
them provided for in Articles 13(3) and (5), 14(1), 19(2),
21, 24(2) and 28(6) and the national measures referred to
in Article 23(3);

(d) a list of rejected health claims and the reasons for their

rejection.

Health claims authorised on the basis of proprietary data shall
be recorded in a separate Annex to the Register together with
the following information:

1) the date the Commission authorised the health claim and the
name of the original applicant that was granted authorisa-
tion;

2) the fact that the Commission authorised the health claim on

Modification, suspension and revocation of authorisations

the basis of proprietary data;

1.
The applicant/user of a claim included in one of the lists
provided for in Articles 13 and 14 may apply for a modification
of the relevant list. The procedures laid down in Articles 15 to
18 shall apply mutatis mutandis.

3) the fact that the health claim is restricted for use unless a
subsequent applicant obtains authorisation for the claim
without reference to the proprietary data of
the original
applicant.

3.

The Register shall be made available to the public.

On its own initiative or

2.
from a
Member State or from the Commission, the Authority shall
issue an opinion on whether a health claim included in the lists
provided for in Articles 13 and 14 still meets the conditions
laid down in this Regulation.

following a request

Article 21

Data protection

It shall forthwith transmit its opinion to the Commission, the
Member States and, where relevant, to the original applicant of
the claim in question. The Authority, in accordance with Article
38(1) of Regulation (EC) No 178/2002, shall make its opinion
public.

1.
The scientific data and other information in the applica-
tion required under Article 15(3) may not be used for the
benefit of a subsequent applicant for a period of five years from
the date of authorisation, unless the subsequent applicant has
agreed with the prior applicant that such data and information
may be used, where:

The applicant/user or a member of
the public may make
comments to the Commission within 30 days of such publica-
tion.

(a) the scientific data and other information has been desig-
nated as proprietary by the prior applicant at the time the
prior application was made; and

The Commission shall examine the opinion of the Authority
and any comments received as soon as possible. If appropriate,
the authorisation shall be modified, suspended or revoked in
accordance with the procedures laid down in Articles 17
and 18.

(b) the prior applicant had exclusive right of reference to the
proprietary data at the time the prior application was made;
and

(c) the health claim could not have been authorised without the
submission of the proprietary data by the prior applicant.

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Until the end of the five-year period specified in paragraph
2.
1, no subsequent applicant shall have the right to refer to data
designated as proprietary by a prior applicant unless and until
the Commission takes a decision on whether a claim could be
or could have been included in the list provided for
in
Article 14 or, where appropriate, Article 13 without the submis-
sion of data designated as proprietary by the prior applicant.

Article 22

National provisions

Without prejudice to the Treaty, in particular Articles 28 and 30
thereof, Member States may not restrict or forbid trade in or
advertising of foods which comply with this Regulation by the
application of non-harmonised national provisions governing
claims made on certain foods or on foods in general.

Article 23

Notification procedure

1.
If a Member State considers it necessary to adopt new
shall notify the Commission and the other
legislation,
Member States of the envisaged measures and give the reasons
justifying them.

it

The Commission shall consult the Standing Committee on
2.
the Food Chain and Animal Health instituted by Article 58(1) of
Regulation (EC) No 178/2002 (hereinafter referred to as ‘the
Committee’) if it considers such consultation to be useful or if a
Member State so requests, and shall give an opinion on the
envisaged measures.

3.
The Member State concerned may take the envisaged
measures six months after the notification referred to in para-
graph 1, provided that the Commission's opinion is not nega-
tive.

If the Commission's opinion is negative, it shall determine, in
accordance with the procedure referred to in Article 25(2) and
before the expiry of the period referred to in the first sub-
paragraph of this paragraph, whether the envisaged measures
may be implemented. The Commission may require certain
amendments to be made to the envisaged measures.

Article 24

Safeguard measures

1. Where a Member State has serious grounds for consid-
ering that a claim does not comply with this Regulation, or that
the scientific substantiation provided for in Article 6 is insuffi-
cient, that Member State may temporarily suspend the use of
that claim within its territory.

It shall inform the other Member States and the Commission
and give reasons for the suspension.

In accordance with the procedure referred to in Article 25
2.
(2), a decision shall be taken, where appropriate after obtaining
an opinion from the Authority.

The Commission may initiate this procedure on its own initia-
tive.

3.
The Member State referred to in paragraph 1 may main-
tain the suspension until the decision referred to in paragraph 2
has been notified to it.

Article 25

Committee procedure

1.

The Commission shall be assisted by the Committee.

2. Where reference is made to this paragraph, Articles 5 and
7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

3.

The Committee shall adopt its rules of procedure.

Article 26

Monitoring

To facilitate efficient monitoring of foods bearing nutrition or
health claims, Member States may require the manufacturer or
the person placing such foods on the market in their territory
to notify the competent authority of that placing on the market
by forwarding to it a model of the label used for the product.

Article 27

Evaluation

By 19 January 2013 at the latest, the Commission shall submit
to the European Parliament and to the Council a report on the
application of this Regulation, in particular on the evolution of
the market in foods in respect of which nutrition or health
claims are made and on the consumers' understanding of
claims, together with a proposal for amendments if necessary.
The report shall also include an evaluation of the impact of this
impact on
Regulation on dietary choices and the potential
obesity and non-communicable diseases.

Article 28

Transitional measures

Foods placed on the market or labelled prior to the date
1.
of application of this Regulation which do not comply with this
Regulation may be marketed until their expiry date, but not
later than 31 July 2009 With regard to the provisions in Article
4(1),
twenty-four months
following adoption of the relevant nutrient profiles and their
conditions of use.

foods may be marketed until

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Products bearing trade marks or brand names existing
2.
before 1 January 2005 which do not comply with this Regu-
lation may continue to be marketed until 19 January 2022 after
which time the provisions of this Regulation shall apply.

Health claims other than those referred to in Articles 13
6.
(1)(a) and 14, which have been used in compliance with
national provisions before the date of entry into force of this
Regulation, shall be subject to the following:

Nutrition claims which have been used in a Member State
3.
before 1 January 2006 in compliance with national provisions
applicable to them and which are not included in the Annex,
may continue to be used until 19 January 2010 under the
responsibility of food business operators and without prejudice
referred to in
to the adoption of
Article 24.

safeguard measures as

4.
Nutrition claims in the form of pictorial, graphic or
symbolic representation, complying with the general principles
of this Regulation, which are not included in the Annex and are
used according to specific conditions and criteria elaborated by
national provisions or rules, shall be subject to the following:

(a) Member States shall communicate to the Commission, by
31 January 2008 at the latest, such nutrition claims and the
national provisions or rules applicable, accompanied by
scientific data in support of such provisions or rules;

(b) the Commission shall,

in accordance with the procedure
referred to in Article 25(2), adopt a Decision concerning the
use of such claims.

Nutrition claims not authorised under
this procedure may
continue to be used for twelve months following the adoption
of the Decision.

5.
Health claims as referred to in Article 13(1)(a) may be
made from the date of entry into force of this Regulation until
the adoption of the list referred to in Article 13(3), under the
responsibility of
they
comply with this Regulation and with existing national provi-
sions applicable to them, and without prejudice to the adoption
of safeguard measures as referred to in Article 24.

food business operators provided that

(a) health claims which have been the subject of evaluation and
authorisation in a Member State shall be authorised as
follows:

(i) Member States shall communicate to the Commission,
by 31 January 2008 at the latest, such claims accompa-
nied by a report evaluating the scientific data in support
of the claim;

(ii) after consulting the Authority, the Commission shall, in
accordance with the procedure referred to in Article 25
(2), adopt a Decision concerning the health claims
authorised in this way.

Health claims not authorised under this procedure may
continue to be used for six months following the adoption
of the Decision;

(b) health claims which have not been the subject of evaluation
and authorisation in a Member State: such claims may
continue to be used provided an application is made
pursuant to this Regulation before 19 January 2008; health
claims not authorised under this procedure may continue to
be used for six months after a decision is taken pursuant to
Article 17(3).

Article 29

Entry into force

This Regulation shall enter into force on the twentieth day
following that of its publication in the Official Journal of the Euro-
pean Union.

It shall apply from 1 July 2007.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 December 2006.

For the European Parliament

The President

J. BORRELL FONTELLES

For the Council

The President

J. KORKEAOJA

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ANNEX

Nutrition claims and conditions applying to them

LOW ENERGY

A claim that a food is low in energy, and any claim likely to have the same meaning for the consumer, may only be made
where the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 ml for
liquids. For table-top sweeteners the limit of 4 kcal (17 kJ)/portion, with equivalent sweetening properties to 6 g of
sucrose (approximately 1 teaspoon of sucrose), applies.

ENERGY-REDUCED

A claim that a food is energy-reduced, and any claim likely to have the same meaning for the consumer, may only be
made where the energy value is reduced by at least 30 %, with an indication of the characteristic(s) which make(s) the
food reduced in its total energy value.

ENERGY-FREE

A claim that a food is energy-free, and any claim likely to have the same meaning for the consumer, may only be made
where the product does not contain more than 4 kcal (17 kJ)/100 ml. For table-top sweeteners the limit of 0,4 kcal (1,7
kJ)/portion, with equivalent sweetening properties to 6 g of sucrose (approximately 1 teaspoon of sucrose), applies.

LOW FAT

A claim that a food is low in fat, and any claim likely to have the same meaning for the consumer, may only be made
where the product contains no more than 3 g of fat per 100 g for solids or 1,5 g of fat per 100 ml for liquids (1,8 g of
fat per 100 ml for semi-skimmed milk).

FAT-FREE

A claim that a food is fat-free, and any claim likely to have the same meaning for the consumer, may only be made where
the product contains no more than 0,5 g of fat per 100 g or 100 ml. However, claims expressed as ‘X % fat-free’ shall be
prohibited.

LOW SATURATED FAT

A claim that a food is low in saturated fat, and any claim likely to have the same meaning for the consumer, may only be
made if the sum of saturated fatty acids and trans-fatty acids in the product does not exceed 1,5 g per 100 g for solids or
0,75 g/100 ml for liquids and in either case the sum of saturated fatty acids and trans-fatty acids must not provide more
than 10 % of energy.

SATURATED FAT-FREE

A claim that a food does not contain saturated fat, and any claim likely to have the same meaning for the consumer, may
only be made where the sum of saturated fat and trans-fatty acids does not exceed 0,1 g of saturated fat per 100 g or
100 ml.

LOW SUGARS

A claim that a food is low in sugars, and any claim likely to have the same meaning for the consumer, may only be made
where the product contains no more than 5 g of sugars per 100 g for solids or 2,5 g of sugars per 100 ml for liquids.

SUGARS-FREE

A claim that a food is sugars-free, and any claim likely to have the same meaning for the consumer, may only be made
where the product contains no more than 0,5 g of sugars per 100 g or 100 ml.

WITH NO ADDED SUGARS

A claim stating that sugars have not been added to a food, and any claim likely to have the same meaning for the
consumer, may only be made where the product does not contain any added mono- or disaccharides or any other food
used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear
on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’.

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L 12/17

LOW SODIUM/SALT

A claim that a food is low in sodium/salt, and any claim likely to have the same meaning for the consumer, may only be
made where the product contains no more than 0,12 g of sodium, or the equivalent value for salt, per 100 g or per
100 ml. For waters, other than natural mineral waters falling within the scope of Directive 80/777/EEC, this value should
not exceed 2 mg of sodium per 100 ml.

VERY LOW SODIUM/SALT

A claim that a food is very low in sodium/salt, and any claim likely to have the same meaning for the consumer, may
only be made where the product contains no more than 0,04 g of sodium, or the equivalent value for salt, per 100 g or
per 100 ml. This claim shall not be used for natural mineral waters and other waters.

SODIUM-FREE or SALT-FREE

A claim that a food is sodium-free or salt-free, and any claim likely to have the same meaning for the consumer, may only
be made where the product contains no more than 0,005 g of sodium, or the equivalent value for salt, per 100 g.

SOURCE OF FIBRE

A claim that a food is a source of fibre, and any claim likely to have the same meaning for the consumer, may only be
made where the product contains at least 3 g of fibre per 100 g or at least 1,5 g of fibre per 100 kcal.

HIGH FIBRE

A claim that a food is high in fibre, and any claim likely to have the same meaning for the consumer, may only be made
where the product contains at least 6 g of fibre per 100 g or at least 3 g of fibre per 100 (kcal.

SOURCE OF PROTEIN

A claim that a food is a source of protein, and any claim likely to have the same meaning for the consumer, may only be
made where at least 12 % of the energy value of the food is provided by protein.

HIGH PROTEIN

A claim that a food is high in protein, and any claim likely to have the same meaning for the consumer, may only be
made where at least 20 % of the energy value of the food is provided by protein.

SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]

A claim that a food is a source of vitamins and/or minerals, and any claim likely to have the same meaning for the
consumer, may only be made where the product contains at least a significant amount as defined in the Annex to Direc-
tive 90/496/EEC or an amount provided for by derogations granted according to Article 6 of Regulation (EC) No
1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and
minerals and of certain other substances to foods (1).

HIGH [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]

A claim that a food is high in vitamins and/or minerals, and any claim likely to have the same meaning for the consumer,
may only be made where the product contains at least twice the value of ‘source of [NAME OF VITAMIN/S] and/or
[NAME OF MINERAL/S]’.

CONTAINS [NAME OF THE NUTRIENT OR OTHER SUBSTANCE]

A claim that a food contains a nutrient or another substance, for which specific conditions are not laid down in this Regu-
lation, or any claim likely to have the same meaning for the consumer, may only be made where the product complies
with all the applicable provisions of this Regulation, and in particular Article 5. For vitamins and minerals the conditions
of the claim ‘source of’ shall apply.

(1) OJ L 404, 30.12.2006, p. 26.

L 12/18

EN

Official Journal of the European Union

18.1.2007

INCREASED [NAME OF THE NUTRIENT]

A claim stating that the content in one or more nutrients, other than vitamins and minerals, has been increased, and any
claim likely to have the same meaning for the consumer, may only be made where the product meets the conditions for
the claim ‘source of’ and the increase in content is at least 30 % compared to a similar product.

REDUCED [NAME OF THE NUTRIENT]

A claim stating that the content in one or more nutrients has been reduced, and any claim likely to have the same
meaning for the consumer, may only be made where the reduction in content is at least 30 % compared to a similar
product, except for micronutrients, where a 10 % difference in the reference values as set in Directive 90/496/EEC shall
be acceptable, and for sodium, or the equivalent value for salt, where a 25 % difference shall be acceptable.

LIGHT/LITE

A claim stating that a product is ‘light’ or ‘lite’, and any claim likely to have the same meaning for the consumer, shall
follow the same conditions as those set for the term ‘reduced’; the claim shall also be accompanied by an indication of the
characteristic(s) which make(s) the food ‘light’ or ‘lite’.

NATURALLY/NATURAL

Where a food naturally meets the condition(s) laid down in this Annex for the use of a nutritional claim, the term ‘natu-
rally/natural’ may be used as a prefix to the claim.