Common Position (EC) No 3/2006 of  8 December 2005  adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Regulation of the European Parliament and of the Council on nutrition and health claims made on foods
Date: 2005-12-08
Institutions: Council of the European Union
Subjects: advertising, agri-foodstuffs, consumer information, consumer protection, foodstuff, labelling

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COMMON POSITION (EC) No 3/2006

adopted by the Council on 8 December 2005

with a view to adopting Regulation (EC) No …/2006 of the European Parliament and of the
Council of …on nutrition and health claims made on foods

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

(4)

(2006/C 80 E/03)

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

Having regard to the proposal from the Commission,

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

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 the Community bear nutrition and health claims. In
order to ensure a high level of protection for consumers
and to facilitate their choice, products put on the market
must be safe and adequately labelled.

Differences between national provisions relating to such
claims may impede the free movement of foods and
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
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.

(1) OJ C 110, 30.4.2004, p. 18.
(2) Opinion of the European Parliament of 26 May 2005, Council
common position of 8 December 2005 and position of the Euro-
pean Parliament of ... (not yet published in the Official Journal).
(3) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Direc-

tive 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
and bodies, or non-commercial
health authorities
communications and information in the press and in
scientific publications. This Regulation should also apply
to trade marks and other brand names which may be
construed as nutrition or health claims.

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).

level

international

At
the Codex Alimentarius has
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 (5) should be adapted to the provisions of this
Regulation as soon as possible. In the meantime, Regu-
lation (EC) No 2991/94 applies for the products it
covers.

(5)

(6)

(7)

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

Act of Accession.

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

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(8)

(9)

There is a wide range of nutrients and other substances
limited to, vitamins, minerals
including, but not
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 established in order to ensure a high level of
consumer protection, 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.

(11)

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. 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 the relevant measures should be
entrusted to the Commission, taking into account the
advice of the European Food Safety Authority.

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
it is appropriate to impose certain
undesirable effect,
restrictions as regards the products bearing claims. In
factors such as the presence of certain
this context,
substances,
the
product or the nutrient profile of the product, are appro-
priate 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.

for example the alcohol content of

(12)

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 (1) presented in a
liquid form and containing more than 1,2 % by volume
of alcohol are not considered as beverages under this
Regulation.

(13)

There is a wide variety of claims currently used in the
foods in some Member
labelling and advertising of
States relating to substances that have not been shown
to be beneficial or for which at present there is not suffi-
cient 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.

(10)

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
would be intended for the sole purpose of governing the
circumstances in which claims may be made. They
should be based on generally accepted scientific data
relative to the relationship between diet and health.
However, profiles should also allow for product innova-
the variability of
tion and should take into account
dietary habits and traditions, and the fact that individual
products may have an important role in the context of
an overall diet.

(14)

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 producing the claimed nutritional or physiolo-
gical effect should be provided by a quantity of the food
that can reasonably be expected to be consumed.

(1) OJ L 183, 12.7.2002, p. 51.

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(15)

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
84/450/EEC of
of Council Directive
enactment
10 September 1984 concerning misleading
and
comparative advertising (1), the Court of Justice of the
European Communities has found it necessary in adjudi-
cating on advertising cases to examine the effect on a
notional, typical consumer. In line with the principle of
proportionality, and to enable the effective application
of the protective measures contained in it, this Regu-
lation 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 provision to prevent
the exploitation of
consumers whose characteristics make them particularly
vulnerable to misleading claims. Where a claim is speci-
fically 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.

(16)

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.

advertising, nutrition labelling

Directive, where a nutrition claim appears on labelling,
in presentation or in advertising, with the exclusion of
generic
should be
compulsory. Where a nutrition claim is made for sugars,
saturates, 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 advertising.

(20) 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 aforementioned list should be subject to
the same conditions of use indicated therein. For
example, claims related to the addition of vitamins and
‘added …’, or
minerals such as ‘with …’,
‘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 …’,

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

(21)

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

Conditions for claims such as ‘lactose-free’ or ‘gluten-
free’, addressed to a group of consumers with specific
disorders, 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 Directive 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.

(19) 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

(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).

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

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

(22) 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.

(3) OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regu-
lation (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)

(24)

and behavioural

There are many factors, other than dietary ones, that can
influence psychological
functions.
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
appropriate, 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.

(25) Health claims other than those referring to the reduction
of disease risk, based on generally accepted scientific
data, should undergo a different type of assessment and
authorisation. It is therefore necessary to adopt a Com-
munity list of such permitted claims after consulting the
European Food Safety Authority.

(26)

the list

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

(29)

(30)

(31)

the European Food Safety Authority and in the subse-
quent authorisation procedure.

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
the agri-food industry, it is appropriate to protect the
investment made by innovators in gathering the infor-
mation and data supporting an application pursuant to
this Regulation. This protection should however be
limited in time in order to avoid the unnecessary repeti-
tion of studies and trials.

(32) Given the particular nature of

foods bearing claims,
additional means to those usually available to moni-
toring bodies should be available in order to facilitate
efficient monitoring of those products.

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

(27) A varied and balanced diet is a prerequisite for good
health and single products have a relative importance in
the context of the total diet. Furthermore, diet is one of
the many factors influencing the onset of certain human
diseases. Other factors such as age, genetic predisposi-
tion, the level of physical activity, the consumption 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.

(34)

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.

(28)

In order to ensure that health claims are truthful, clear,
reliable and useful
to the consumer in choosing a
healthy diet, the wording and the presentation of health
claims should be taken into account in the opinion of

(35)

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 (2),

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

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

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HAVE ADOPTED THIS REGULATION:

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

quality of water intended for human consumption (2).

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

Article 2

Definitions

1.

For the purposes of this Regulation:

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 effective 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, including foods which are placed on the
market unpacked or supplied in bulk.

It 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
nutrition or health claim in that
labelling, presentation or
advertising which complies with the provisions of this Regu-
lation.

This Regulation shall apply without prejudice to the

4.
following Community provisions:

(a) Directive 89/398/EEC and Directives adopted on the basis

thereof;

(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 (1);

(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 Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of
food law, establishing the European Food Safety Authority
and laying down procedures in matters of food safety (3),
shall apply;

(b) the definition of

‘food supplement’ set out

in Direc-

tive 2002/46/EC shall apply;

(c) the definitions of ‘nutrition labelling’,
‘fat’,

‘carbohy-
drate’,
‘poly-
unsaturates’ and ‘fibre’ set out in Directive 90/496/EEC
shall apply;

‘mono-unsaturates’,

‘saturates’,

‘protein’,

‘sugars’,

(d) the definition of

‘labelling’ set out in Article 1(3)(a) of

Directive 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
in
including pictorial, graphic or symbolic representation,
any form, which states, suggests or implies that a food has
particular characteristics;

2.

‘nutrient’ means protein, carbohydrate, fat, 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;

3.

‘other substance’ means a substance other than a nutrient
that has a nutritional or physiological effect;

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

(EC) No 1882/2003.

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

(3) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

(EC) No 1882/2003.

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

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4.

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

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

(a) the energy (calorific value) it

(i) provides,

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

(iii) does not provide; and/or

(b) the nutrients or other substances it

(i) contains,

(ii) contains in reduced or increased proportions, or

(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
sufficient 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 24(2), taking into account the special condi-
tions present in Member States;

(e) refer to changes in bodily functions which could give rise
fear in the consumer, either textually or

to or exploit
through pictorial, graphic or symbolic representations.

(iii) does not contain;

Article 4

5.

6.

‘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;

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

7.

‘Authority’ means the European Food Safety Authority
established 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,
presentation 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:

Conditions for the use of nutrition and health claims

1.
By … (*), the Commission shall, in accordance with the
procedure referred to in Article 24(2), establish specific nutrient
profiles and the conditions, including exemptions, which shall
be respected for the use of nutrition and health claims on foods
and/or categories of foods.

These nutrient profiles established for food and/or certain cate-
gories of food, and the conditions for the use of nutrition or
health claims with respect to the nutrient profiles, shall be laid
down 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
foods) in the diet of the population in general or, as appro-
priate, of certain risk groups including children;

(c) the overall nutritional composition of the food and the
presence of nutrients that have been scientifically recog-
nised as having an effect on health.

(a) be false, ambiguous or misleading;

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

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

adequacy of other foods;

(*) Twenty four months after the date of entry into force of this Regu-

lation.

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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;

Article 5

General conditions

(ii) the choice and balance of nutrients to be taken into

account;

The use of nutrition and health claims shall only be

1.
permitted if the following conditions are fulfilled:

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

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

(v) 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.

Nutrient profiles and their conditions of use shall be updated to
take into account relevant scientific developments in accord-
ance with the procedure referred to in Article 24(2).

2.
By way of derogation from paragraph 1, nutrition claims
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.

Beverages containing more than 1,2 % by volume of

3.
alcohol shall not bear:

(a) health claims;

(b) nutrition claims, other than those which refer to a reduc-

tion in the alcohol or energy content.

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

(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 data;

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

made:

(i) is contained in the final product in a significant quan-
tity 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 data; 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
data;

(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
the
to be consumed provides a significant quantity of
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 data;

(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.

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 24(2) and in the light of
scientific evidence.

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

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Article 6

Scientific substantiation for claims

2.
Amendments to the Annex shall be adopted in accord-
ance with the procedure referred to in Article 24(2) and, where
appropriate, after consulting the Authority.

Nutrition and health claims shall be based on and

1.
substantiated by generally accepted scientific data.

A food business operator making a nutrition or health

2.
claim shall justify the use of the claim.

3.
The competent authorities of 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.

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 to be provided shall consist of
information in
Group 2 as defined in Article 4(1) of Directive 90/496/EEC.

In addition and as the case may be, the amount(s) of 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 of the nutrition information and be
expressed in accordance with Article 6 of Directive 90/496/
EEC.

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

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.

2.
Health claims shall only be permitted if the following
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

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.

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

present a health risk if consumed to excess.

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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 24(2) and, if necessary, in consultation
with interested parties,
in particular food business operators
and consumer groups.

(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 included in the list provided for in paragraph 3 may
be made without undergoing the authorisation procedure laid
down in Articles 15 to 18, if they are:

(i) based on generally accepted scientific data; and

Article 11

(ii) well understood by the average consumer.

National medical associations and health-related charities

In the absence of specific Community rules concerning recom-
mendations of or endorsements by national medical associa-
tions 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.

2. Member States shall provide the Commission with lists of
claims as referred to in paragraph 1 by … (*) at the latest
accompanied by the conditions applying to them and by refer-
ences to the relevant scientific justification.

After consulting the Authority,

3.
the Commission shall
adopt, in accordance with the procedure referred to in Article
24(2), a Community list of permitted claims as referred to in
paragraph 1, and all necessary conditions for the use of these
claims by … (**) at the latest.

4.
Any changes to the list referred to in paragraph 3, based
on generally accepted scientific data, shall be adopted in
accordance with the procedure referred to in Article 24(2),
after consulting the Authority, on the Commission's own initia-
tive or following a request by a Member State.

Any additions of claims to the list referred to in para-
5.
graph 3 based on newly developed scientific data and/or which
include a request for the protection of proprietary data shall be
adopted following the procedure laid down in Articles 15 to
18.

Article 14

Reduction of disease risk claims

Article 13

Health claims other than those referring to the reduction
of disease risk

1.

Health claims describing or referring to:

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

opment and the functions of the body, or

1.
Notwithstanding Article 2(1)(b) of Directive 2000/13/EC,
reduction of disease risk claims may be made where they have
been authorised in accordance with the procedure laid down in
Articles 15 to 18 of this Regulation for inclusion in a Com-
munity list of such permitted claims together with all the neces-
sary conditions for the use of these claims.

(*) Last day of the month of entry into force of this Regulation, plus

one year.

(**) Last day of the month of entry into force of this Regulation, plus

three years.

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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
labelling exists, the presentation or advertising shall also bear a
statement indicating that the disease to which the claim is refer-
ring 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:

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

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

health claim;

(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;

(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 24(2)
implementing rules for the application of this
Article, including rules concerning the preparation and presen-
tation of the application.

Before … (*),

5.
shall publish detailed
guidance to assist applicants in the preparation and the presen-
tation of the application.

the Authority

(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;

Article 16

(ii) inform without delay the Authority; and

Opinion of the Authority

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

available

tion supplied by the applicant
Authority;

(b) the Authority shall:

(i) inform without delay the other Member States and the
the application and shall make the
information

Commission of
application
any
supplied by the applicant available to them;

supplementary

and

(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;

1.
In giving its opinion, the Authority shall endeavour to
respect a time limit of six months from the date of receipt of a
valid application. Such time limit shall be extended whenever
the Authority seeks supplementary information from the appli-
cant as provided for in paragraph 2.

The Authority or a national competent authority through
2.
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:

(a) verify that the proposed wording of the health claim is

substantiated by scientific data;

(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;

(b) consider whether the wording of the health claim complies

with the criteria laid down in this Regulation;

(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
which is available to demonstrate that the health claim
complies with the criteria provided for in this Regulation;

(c) give advice on whether the proposed wording of the health
to the average

claim is understandable and meaningful
consumer.

(*) First day of the sixth month following the date of entry into force

of this Regulation.

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

A final decision on the application shall be adopted in

3.
accordance with the procedure referred to in Article 24(2).

(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) the recommended wording of the proposed health claim,
including, as the case may be, the specific conditions of
use;

4.
The Commission shall, without delay, inform the appli-
cant 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.
in conformity with the conditions
13 and 14 may be used,
applying to them, by any food business operator, if they are
not restricted for use in accordance with the provisions of
Article 20.

(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.

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.

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
reasons for its opinion and the information on which its
opinion was based.

Article 18

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

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

Modification, suspension and revocation of authorisations

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

The applicant/user of a claim included in one of the lists
1.
provided for in Articles 13 and 14 may apply for a modifica-
tion of the relevant list. The procedure laid down in Articles 15
to 17 shall apply, mutatis mutandis.

Article 17

Community authorisation

the Commission shall submit

1. Within three months after receiving the opinion of the
to the Committee
Authority,
referred to in Article 22(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 considera-
tion. Where the draft Decision is not in accordance with the
opinion of the Authority, the Commission shall provide an
explanation for the differences.

On its own initiative or following a request

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.

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.

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

Any draft decision to amend the lists of permitted health

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

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 procedure laid down in Article 17.

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CHAPTER V

has agreed with the prior applicant that such data and informa-
tion may be used, where:

GENERAL AND FINAL PROVISIONS

Article 19

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’.

2.

The Register shall include the following:

(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), 14(1), 18(2), 20, 23(2)
and 27(6) and the national measures referred to in Article
22(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 authori-
sation;

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

the basis of proprietary data;

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.

Article 20

Data protection

(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

(b) the prior applicant had exclusive right of reference to the
the time the prior application was

proprietary data at
made; and

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

2.
Until the end of the seven-year period specified in para-
graph 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
submission of data designated as proprietary by the prior appli-
cant.

Article 21

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 22

Notification procedure

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

The scientific data and other information in the applica-
1.
tion required under Article 15(2) may not be used for the
benefit of a subsequent applicant for a period of seven years
from the date of authorisation, unless the subsequent applicant

The Commission shall consult the Standing Committee
2.
on 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.

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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.

Article 25

Monitoring

If the Commission's opinion is negative, it shall determine, in
accordance with the procedure referred to in Article 24(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 measure.

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 23

Safeguard measures

Article 26

Evaluation

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
insufficient, 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.

2.
In accordance with the procedure referred to in Article
24(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.

By … (*) at the latest, the Commission shall submit to the Euro-
pean 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.

Article 27

Transitional measures

1.
Foods placed on the market or labelled prior to the date
of application of this Regulation which do not comply with
this Regulation may be marketed until their expiry date, but
not later than … (**). With regard to the provisions in Article
4(1), foods may be marketed until12 months following adop-
tion of the relevant nutrient profiles and their conditions of
use.

Article 24

Committee procedure

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

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 three months.

3.

The Committee shall adopt its rules of procedure.

3.
Nutrition claims which have been used in a Member State
before 1 January 2005 in compliance with national provisions
applicable to them and which are not included in the Annex,
may continue to be used until … (****) under the responsibility
of food business operators and without prejudice to the adop-
tion of safeguard measures as referred to in Article 23.

(*) Last day of the fifth month following the date of entry into force of

this Regulation, plus six years.

(**) Last day of the 18th month following the date of entry into force

of this Regulation.

(***) Date of entry into force of this Regulation, plus 10 years.
(****) Two years after the date of entry into force of this Regulation.

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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
to the
rules,
following:

shall be subject

(a) Member States shall communicate to the Commission, by
… (*) 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 24(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 food business operators provided that 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 23.

other

claims

Health

6.
in
Article 13(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:

referred

those

than

to

(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 … (*) at the latest, such claims accompanied by a
report evaluating the scientific data in support of the
claim;

(ii) after consulting the Authority, the Commission shall, in
accordance with
in
Article 24(2), adopt a Decision concerning the health
claims authorised in this way.

procedure

referred

the

to

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 … (**), 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 28

Entry into force

This Regulation shall enter
into force on the 20th day
following its publication in the Official Journal of the European
Union.

It shall apply from … (***).

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

Done at…, ….

For the European Parliament

The President

For the Council

The President

(*) Last day of the month of entry into force of this Regulation, plus

one year.

(**) Twelve months after the date of entry into force of this Regulation.
(***) First day of the sixth months following the date of entry into

force of this Regulation.

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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 one 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 one 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 100ml 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 per100 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 SUGAR

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

SUGAR-FREE

A claim that a food is sugar-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 sugar per 100 g or 100 ml.

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WITH NO ADDED SUGAR

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’.

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 7 of Regulation (EC) No …/
2006 of the European Parliament and of the Council of … on the addition of vitamins and minerals and of certain other
substances to foods (1).

(1) OJ L …

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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
Regulation, 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.

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 Council Directive
90/496/EEC shall be acceptable and for sodium, or the equivalent value for salt, where a 25 % difference shall be accep-
table.

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.

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. The Commission forwarded to Council on 17 July 2003 a proposal for a Regulation of the Euro-
pean Parliament and of the Council on nutrition and health claims made on foods (1). The proposal
is based on Article 95 of the Treaty.

2. The European Parliament adopted its first reading opinion on 26 May 2005 (2).

The European Economic and Social Committee gave its opinion on 29 February 2004 (3).

3. On 8 December 2005, the Council adopted its common position in accordance with Article 251 of

the Treaty.

II. OBJECTIVES

The proposed Regulation covers nutrition and health claims used in the labelling, presentation and
advertising of foods and aims at setting conditions for the use of such claims.

The main objectives of this proposal are:

— to improve the free movement of goods within the internal market, ensuring fair competition in

the area of foods and increasing legal security for economic operators,

— to achieve a high level of consumer protection by ensuring that appropriate information is received

and that the claims are duly assessed,

— to promote and protect innovation in the area of foods.

III. ANALYSIS OF THE COMMON POSITION

1. General remarks

The Council's common position conforms to the objectives of the Commission proposal while
introducing a certain number of modifications among which:

1. The nutrient profiles ( recitals 9, 10 and 11, Article 4(1))

The Council maintained the concept of nutrient profiles as an important element to ensure the
efficient application of the Regulation in relation to nutrition and health claims. The original
proposal was considerably developed to focus more closely on the purpose and the scope of the
nutrient profiles, and the procedure to be followed to elaborate them. Adequate safeguards were
introduced to accommodate concerns regarding their scientific objectivity, the preservation of
different dietary habits and national traditions, and the involvement of stakeholders in the
process.

2. Health claims (Articles 10, 11, 12 and13)

The original Commission proposal envisaged the prohibition of several categories of health
claims. The Council maintained the ban of some of these claims (Article 12), and, for others,
stipulated that they could be used under certain conditions (referred to in Article 10(3) and in
Article 13(1) (b) and (c).

(1) Doc. COM/2003/ 0424 final – COD 2003/0165.
(2) Doc. 9200/05.
(3) OJ C 112, 30.4.2004, p. 44.

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Article 13 of the common position provides that a list of certain health claims (which do not
refer to disease reduction) will be adopted by the Commission within three years from the adop-
tion of the Regulation, based on suggestions by the Member States. The scope of this Article has
been widened and now includes claims referring to psychological and behavioural functions
(paragraph 1 (b)) and slimming and weight control (paragraph 1(c)). Moreover, an authorisation
procedure may be used for adding health claims to the list which are based on newly developed
scientific data and/or include a request for the protection of proprietary data.

As regards recommendations of or endorsements by national medical associations and health-
related charities, a new Article 11 is envisaged, according to which national legislation may
continue to apply in compliance with the provisions of the Treaty until such time as Community
rules are adopted.

3. The scope of nutrition claims (recital 5, Article 2(4), Article 27(4))

While the original proposal did not foresee the use of symbols/signposting as nutrition claims,
the Council has examined this question in detail, being confronted with growing demands
regarding the use of both positive and negative signposting on the nutritional status of a food
(to be placed, for example, on supermarket shelves). As a result, the common position clarifies
that the proposed Regulation only applies to beneficial claims, while claims referring to a non-
beneficial effect of the food will not be covered. In this respect, it is stated that Member States
intending to introduce national schemes relating to non-beneficial claims should notify these
schemes to the Commission and to Member States in accordance with Directive 98/34/EC
(recital 5).

Furthermore, in order to take account of certain nutrition claims in pictorial, graphic or symbolic
form used in several Member States, a transitional arrangement has been introduced in Article
27(4), which provides that national rules and criteria for the use of logos and symbols shall be
authorised, if complying with the general principles of the Regulation.

The Commission has accepted the common position agreed by the Council.

2. European Parliament amendments

In its Plenary vote on 26 May 2005, the European Parliament adopted 75 amendments to the
proposal (Amendments 22 and 23 are linguistic and do not affect the English version).

The Council:

(a) introduced in the common position 35 amendments in full, in part or in principle, as follows:

Recitals

Amendment 1 (recital 1(new)) and Amendment 10 (recital 19): are partly taken up in recital 10,
last sentence, focusing on nutrient profiles and the conditions for their use. The recital specifi-
cally refers to the variability of dietary habits and traditions, and to the fact that individual
products may have an important role in the context of an overall diet.

Amendment 2 (recital 3a (new)): is accepted in part in recital 4, where it is clarified that the
Regulation should not apply to claims made in non-commercial communications such as
dietary guidelines or advice issued by public health authorities and bodies, or non-commercial
communication and information in the press and scientific publications.

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Amendment 4 (recital 7): is accepted in substance and in part in recital 11. In particular, it is
specified that the advice of the European Food Safety Authority will be taken into account by
the Commission, when drawing up the nutrient profiles and the related applicable measures.

Amendment 6 (recital 13) and Amendment 7 (recital 15): have been slightly reformulated and
inserted in recitals 20 and 23 respectively.

Amendment 8 (recital 16): the common position integrates part of this amendment, in substance,
in recital 24 and in Article 13. In practice, it is considered that while the reference to the rate or
amount of weight loss should be prohibited, as envisaged in the original proposal, the claims
making reference to slimming, weight-control, or to the reduction of the available energy from
the diet could be made if based on generally accepted scientific data and if well understood by
the average consumer.

Amendment 9 (recital 17): is acceptable in part and has been integrated in recital 25.

Amendment 12 (recital 22): is inserted, with a slight reformulation, in recital 30.

Amendment 14 (recital 26): is acceptable in its first part, introduced in recital 33.

Articles

Amendment 16 (Article 1(2)): taken up in part in Article 1(2) while the proposed exemption of
products sold in bulk and of fruits and vegetables from the scope of the Regulation can not be
supported by the Council.

Amendment 17 (Article 1(3a) new): partly taken up in Article 1(4).

Amendments 20 and 21 (Article 2(1)): fully taken up in Article 2.

Amendments 26 and 27 (Article 3(2)(a) and (c)): fully taken up in Article 3.

Amendment 28 (Article 3(2)(da) new)): first part is reflected in Article 3 second indent point (c),
while the second part is covered in substance by the following point (d).

Amendment 30 (Article 5(1)(a)): first part is now integrated in Article 5(1)(a).

Amendments 31, 32 and 33 (Article 5(1)(b), (c) and (d)): fully taken up as suggested.

Amendment 36 (Article 7): the first part of this Amendment has been inserted in recital 10. The
reference to food supplements and Directive 2002/46/EC (which requires, among others, that
the amounts of nutrients or other substances declared shall be those per portion of the product
as recommended for daily consumption on the labelling) can be found in Article 7 third para-
graph.

Amendments 41 and 91 (Article 11, title): are fully incorporated as proposed.

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Amendment 42 (Article 11(1)): this amendment has been taken up, partly and in principle, in the
common position. In practice, some of the health claims originally proposed for a restriction
under Article 11 (notably in paragraph 1(a), (b), part of (c), and part of (d) of the original
proposal) have been removed from that Article and are now referred to either in Article 10(3)
where they can be used under specific conditions), in Article 11 (where national rules may
apply in absence of relevant Community rules) or in Article 13(1)(b) and (c) where they are
eligible for inclusion in the list of health claims if they are based on generally accepted scientific
data and well understood by the average consumer.

Amendments 43 and 93 (Article 11(2): these amendments are agreed in substance and can be
found in Article 10(4).

Amendment 44 (Article 12(1)): taken up in part, as regards the deletion of the term ‘normal’ in
Article 13(1) and with respect to the need to properly substantiate the claim in Article 13(2)
where the need to refer to the relevant scientific justification is now referred to.

Amendment 45 (Article 12(2)first indent): taken up in part and in principle in Article 13(5),
whereby it is possible to include health claims into the approved list following an application
for authorisation by interested parties.

Amendment 50 (Article 14(2)(b): fully incorporated in Article 15(3)(b).

Amendment 51 (Article 14(2)(e)): agreed in part, notably as regards the deletion of the obligation
to provide a proposed wording in all Community languages. As regards illustrative measures for
SMEs, it is pointed out that implementing rules for the application of Article 15, including
those concerning the preparation and the presentation of the application are envisaged in para-
graph 4 of that Article. In addition, Article 15(5) foresees that detailed guidelines to assist appli-
cants will be issued by the Authority before the date of application of the Regulation.

Amendment 57 (Article 15(1)): partly taken up as regards the time limit envisaged for the
Authority to give its opinion, which has been extended to six months.

Amendment 61 (Article 15(4)(c)): agreed in principle, the reference to all Community languages
has been deleted, as envisaged by the Amendment.

Amendment 62 (Article 15(4a new): agreed in part and in principle. Article 16(6) of the
common position specifically envisages that the applicant may make comments to the Commis-
sion on the opinion of the Authority within 30 days of its publication. Article 17(1) provides
that the opinion of the Authority and other legitimate factors relevant to the matter will be
taken into account by the Commission in its draft decision.

Amendment 72 (Article 26): concerning transitional measures for products already on the market
and for health claims already in use, has been largely taken up in substance. A new Article 27 is
now entirely dedicated to the transitional measures applicable,
including the case of foods
already placed on the market, products bearing trade marks or brand names existing before 1
January 2005, and existing nutrition claims and health claims;

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(b) did not include 38 amendments in the common position.

With respect to Amendments 3, 5, 11, 85, 24, 25, 29, 34, 35, 39,40, 46, 47, 48, 49, 53, 55,
56, 58, 60, 63, 64, 65, 66, 68, 69, 96, 70, the Council followed the position expressed by the
Commission.

As regards Amendment 85 (Article 1(1a new)), exempting trade marks from the scope of the
Regulation, it can be pointed out that a 10-year transitional period is envisaged in Article 27(2)
for existing products bearing trade marks or brand names which do not comply with the Regu-
lation.

In relation to Amendments 13, 15, 18, 37, 38, 52, 54, 59, 67 and 71, accepted in part or in
principle by the Commission but not included in the common position, the following considera-
tions can be made:

Amendment 13

The Council notes that the text of the common position already provides for the consultation of
stakeholders in the process of implementing the proposed Regulation (as in Article 4(1) fifth
subparagraph or in Article 10(4)) and takes in due consideration the needs of the European
food industry. The promotion of innovation, for example, is underlined among others in recitals
10 and 31 and in Article 13(5) (on health claims other than those referring to the reduction of
disease risk where data protection is required). Article 27(new) elaborates detailed transitional
measures for existing products and for nutrition and health claims already in use.

Amendment 15

The suggested recital is considered inappropriate because it does not correspond to any substan-
tial provision in the text of the proposed Regulation. The fact that information campaigns on
nutrition issues and healthy eating habits can play an important role to prevent obesity and
related diseases is not put in question by the Council.

Amendment 18

The Council considers that food supplements fall entirely within the scope of the proposed
Regulation and therefore does not support this Amendment. Specific labelling requirements in
the case of food supplements are referred to in Article 7 third indent.

Amendment 37

The obligatory involvement of consumer panels whenever the list of nutrition claims, in Annex
to the Regulation, is amended, is likely to entail an additional burden, in terms of timing and
costs, on the process of adapting the Annex. It is considered that Article 5(2) of the common
position, listing the general conditions applicable to all claims, is sufficiently clear in this respect
as it stipulates that ‘the use of nutrition and health claims shall only be permitted if the average
consumer can be expected to understand the beneficial effects as expressed in the claim’.

Amendment 38

The suggestion to allow comparative nutrition claims between foods of different categories was
not taken up in the common position because questions were raised as regards the possible
consequences on the clarity and scientific objectivity of information directed at consumers.

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Amendment 52

In the opinion of the Council, the proposed additional requirement for a sample of the proposed
food packaging on which the claim is to be made, at an early stage of the authorisation proce-
dure, would imply an additional cost for the applicant without commensurate benefit. It is also
noted that Article 25 provides that a model of the label used for the product may be requested
by the Member States to the manufacturer or the person responsible for the placing on the
market, for monitoring purposes.

Amendment 54

The Council considers that, in order to simplify the overall process of authorisation, several
requirements have already been streamlined (e.g.
language requirements). Moreover, Article
15(4) and (5) provides that, in relation to the preparation and presentation of the application,
the Commission and the Authority will respectively establish implementing rules and detailed
guidance to assist applicants.

Amendment 59

The Council preferred to maintain the original text of the proposal, with a slight modification,
because it is more accurate in describing the role and the competencies of the Authority in the
evaluation of the applications.

Amendment 67

The Council considers that the suggested period of three months for the Commission to
examine the opinion of the Authority would not add clarity to the text. It is noted that,
according to Article 18(2) of the common position, the opinion of the Authority should be
examined together with any comments received from the applicants or members of the public,
for which a period of 30 days following the opinion of the Authority isenvisaged. Moreover
Article 17(1) on the procedure to be used already establishes detailed deadlines in this respect.

Amendment 71

The Council considers that the suggested period of three years for the Commission to present a
report on the application of the proposed Regulation is not appropriate, given that several of its
basic aspects (such as the nutrient profiles or the list of permitted health claims) will not yet be
implemented at that moment in time.

As regards the second part of the Amendment, asking to examine, in particular, the problems
encountered in the application of Article 1(4a) (new) (Amendment 85) on the exemption of
products bearing trade marks, it is recalled that, according to Article 27 of the common posi-
tion, such products may continue to be marketed, even if not in compliance with the Regu-
lation, for a time period of 10 years. The current wording of Article 26 leaves open the possibi-
lity, for the Commission, to examine this question in its evaluation of the application of the
Regulation of the market evolution for the products concerned and of the consumer's under-
standing of claims.

3. Other innovations introduced by the Council

Other innovations introduced in the common position include:

— alcoholic beverages: the general prohibition in the use of claims in the case of alcoholic beverages,
with the exception of claims that refer to a reduction in alcohol or in energy content, has been
maintained in Article 4(3). In addition, it has been clarified in Article 4(4) that, in the absence of
specific Community rules regarding such claims used in beverages which normally contain
alcohol, relevant national rules may apply in compliance with the provisions of the Treaty;

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— commercial brand names or trade marks: the use of commercial brand names or trademarks which
could at the same time be considered as claims and fall under the scope of the proposed Regu-
lation because of their representation or wording, has been addressed in Article 1(3). This new
provision allows such brand-names or trademarks to be used without undergoing an authorisa-
tion procedure, provided that they are accompanied by a related nutrition or health claim in the
labelling, presentation or advertising, which complies with the provisions of this Regulation.

— In order to accommodate concerns regarding the application of the Regulation to existing trade
marks and brand names, a 10-year transitional period has been introduced for brand names or
trade marks in use before the 1 January 2005, after which they should comply with the Regu-
lation (Article 27(2)).

Annex

The conditions for the use of the nutrition claims contained in the Annex to the Regulation have
been modified to take into account, in particular, recent technical and scientific developments in
this field.