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
Date: 2006-12-20
Institutions: Council of the European Union, European Parliament
Subjects: consumer protection, food safety, food supplement, human nutrition, inorganic chemical product, vitamin

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REGULATION (EC) No 1925/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the addition of vitamins and minerals and of certain other substances to foods

of 20 December 2006

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

Community provisions, relevant national rules may apply
without prejudice to the provisions of the Treaty.

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)

limited to,

There is a wide range of nutrients and other ingredients
that might be used in food manufacturing, including, but
not
including trace
vitamins, minerals
elements, amino acids, essential fatty acids, fibre, various
plants and herbal extracts. Their addition to foods is
regulated in Member States by differing national rules
that impede the free movement of these products, create
unequal conditions of competition and thus have a direct
impact on the functioning of the internal market. It is
therefore necessary to adopt Community rules harmo-
nising national provisions relating to the addition of vita-
mins and minerals and of certain other substances to
foods.

This Regulation aims to regulate the addition of vitamins
and minerals to foods and the use of certain other
substances or ingredients containing substances other
than vitamins or minerals that are added to foods or
used in the manufacture of foods under conditions that
result in the ingestion of amounts greatly exceeding those
reasonably expected to be ingested under normal condi-
tions of consumption of a balanced and varied diet and/
or would otherwise represent a potential risk to consu-
mers.
specific Community rules
regarding prohibition or restriction of use of substances
or ingredients containing substances other than vitamins
or minerals under this Regulation or under other specific

In the absence of

(1) OJ C 112, 30.4.2004, p. 44.
(2) Opinion of the European Parliament of 26 May 2005 (OJ C 117 E,
18.5.2006, p. 206), Council Common Position of 8 December 2005
(OJ C 80 E, 4.4.2006, p. 27) and Position of the European Parliament of
Journal).
16 May 2006 (not yet published in the Official
Council Decision of 12 October 2006.

(3)

(4)

(5)

(6)

Some Member States require the mandatory addition of
some vitamins and minerals to certain ordinary foods,
for
reasons dictated by public health considerations.
These reasons may be pertinent at national or even
regional level, but would not currently justify harmonisa-
tion of the mandatory addition of nutrients across the
Community. However, if and when this became appro-
priate, such provisions could be adopted at Community
level. Meanwhile, it would be useful for information on
such national measures to be compiled.

Vitamins and minerals may be added to foods voluntarily
by food manufacturers or must be added as nutritional
substances as provided for by specific Community legisla-
tion. They may also be added for technological purposes
as additives, colourings, flavourings or other such uses
including authorised oenological practices and processes
provided for by relevant Community legislation. This
Regulation should apply without prejudice to the specific
Community rules concerning the addition of vitamins
and minerals to or their use in specific products or
groups of products or their addition for purposes other
than those covered by this Regulation.

Given that detailed rules on food supplements containing
vitamins and minerals have been adopted by Direc-
tive 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 supple-
ments (3), provisions of this Regulation regarding vita-
mins and minerals should not apply to food supple-
ments.

Vitamins and minerals are added to foods by manufac-
turers for a number of purposes including to restore their
content where this has been reduced during manufac-
turing, storage or handling procedures or to provide a
similar nutritional value to foods for which they are
intended as alternatives.

(3) 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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(7)

(8)

(9)

An adequate and varied diet can, under normal circum-
stances, provide all necessary nutrients for normal devel-
opment and maintenance of a healthy life in quantities
such as those established and recommended by generally
acceptable scientific data. However, surveys show that
this ideal situation is being achieved neither for all vita-
mins and minerals nor by all groups of the population
across the Community. Foods to which vitamins and
minerals have been added appear to make an appreciable
contribution to the intake of these nutrients and as such
may be considered to make a positive contribution to
overall intakes.

(11)

In order to keep up with scientific and technological
developments,
it is important to revise the above lists
promptly, when necessary. Such revisions would be
implementing measures of a technical nature and their
adoption should be entrusted to the Commission in
order to simplify and expedite the procedure.

in the

socio-economic

Some nutrient deficiencies, although not very frequent,
can be demonstrated to exist at present in the Com-
munity. Changes
situation
prevailing in the Community and the life styles of
different groups of the population have led to different
nutritional requirements and to changing dietary habits.
This in turn has led to changes in the energy and nutrient
requirements of various groups of the population and to
intakes of certain vitamins and minerals for these groups
that would be below those recommended in different
Member States. In addition, progress in scientific knowl-
edge indicates that intakes of some nutrients for main-
taining optimal health and well-being could be higher
than those currently recommended.

Only vitamins and minerals normally found in and
consumed as part of the diet and considered essential
nutrients
should be allowed to be added to foods
although this does not mean that their addition thereto is
necessary. Controversy as to the identity of these essential
nutrients that could potentially arise should be avoided.
It is therefore appropriate to establish a positive list of
these vitamins and minerals.

(12)

Foods to which vitamins and minerals are added are in
most cases promoted by manufacturers and may be
perceived by consumers as products having a nutritional,
physiological or other health advantage over similar or
other products without such nutrients added. This may
induce consumer choices that may be otherwise undesir-
able. To counter this potential undesirable effect,
it is
considered appropriate to impose some restrictions on
the products to which vitamins and minerals can be
added,
in addition to those that would result naturally
from technological considerations or become necessary
for safety reasons when maximum limits of vitamins and
minerals in such products are set. The content in the
product of certain substances, such as alcohol, would, in
this context, be an appropriate criterion for not allowing
vitamins and minerals to be added to it. Any derogation
from banning the addition of vitamins and minerals to
alcoholic beverages should be limited to protecting tradi-
tional wine recipes, with the relevant products being noti-
fied to the Commission. No claims about any nutritional
or health benefits of the additions should be made. More-
over, in order to avoid any confusion for the consumer
as to the natural nutritional value of fresh foods, the
addition of vitamins and minerals thereto should not be
allowed.

(13)

This Regulation is not intended to cover the use of vita-
mins and minerals in trace quantities as authenticity
markers used with the objective of combating fraud.

(10)

The chemical substances used as sources of vitamins and
minerals which may be added to foods should be safe
and also be bio-available i.e. available to be used by the
body. For this reason a positive list of these substances
should also be established. Such substances that have
been approved by the Scientific Committee on Food in
an Opinion expressed on 12 May 1999, on the basis of
the above criteria of safety and bio-availability, and can
be used in the manufacture of foods intended for infants
and young children, other foods for particular nutritional
uses or food supplements should appear in this positive
list. Although sodium chloride (common salt) does not
appear among the substances in this list, it may continue
to be used as an ingredient in the preparation of food.

(14)

Excessive intakes of vitamins and minerals may result in
adverse health effects and it is therefore necessary to set
maximum amounts for them when they are added to
foods, as the case may be. These amounts must ensure
that the normal use of the products, under the instruc-
tions for use provided by the manufacturer and in the
context of a diversified diet, will be safe for the consumer.
Therefore those amounts should be total maximum safe
levels for the vitamins and minerals present in the food
naturally and/or added to the food for whatever purpose,
including for technological uses.

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(15)

(16)

For that reason those maximum amounts and any other
conditions
restricting their addition to foods, where
necessary, should be adopted taking into account their
upper safe levels established by scientific risk assessment
based on generally acceptable scientific data and their
intake from other foods. Due account should
potential
also be taken of the population reference intakes of vita-
mins and minerals. Where it is necessary, for certain vita-
mins and minerals, to establish restrictions regarding the
foods to which they can be added (e.g. the addition of
iodine to salt), priority should be given to the purposes
of restoring their content where this has been reduced
during manufacturing, storage or handling procedures
and of providing a similar nutritional value to foods for
which those foods are intended as alternatives.

20 December 2006 on nutrition and health claims made
on foods (2).

(19) Given the nutritional importance of products to which
vitamins and minerals have been added and their poten-
tial impact on dietary habits and overall nutrient intakes,
the consumer should be able to evaluate the global nutri-
tional quality of those products. Therefore, by derogation
from Article 2 of Council Directive 90/496/EEC of
24 September 1990 on nutrition labelling for food-
stuffs (3), nutrition labelling should be compulsory.

Vitamins and minerals added to foods should result in a
minimum amount being present in the food. Otherwise
the presence of too small and insignificant amounts in
these fortified foods would not offer any benefit
to
consumers and would be misleading. The same principle
underlies the requirement that these nutrients should be
present in a significant amount in the food in order to be
allowed to be declared in nutrition labelling. Therefore it
would be appropriate that the minimum amounts of vita-
mins and minerals in foods to which those vitamins and
minerals have been added should be the same as those
for those
significant amounts that should be present
nutrients to be declared in nutrition labelling unless
otherwise provided for by appropriate derogations.

(20) A normal and varied diet contains many ingredients,
which in turn contain many substances. The intake of
these substances or
resulting from their
ingredients
normal and traditional use in current diets would not
cause concern and does not need to be regulated. Some
substances other than vitamins and minerals or ingredi-
ents containing them are added to foods as extracts or
concentrates and may result in intakes that are signifi-
cantly higher than those that could be ingested through
eating an adequate and varied diet. The safety of such
practices is in some cases seriously contested and the
benefits are unclear; therefore they should be regulated. It
is appropriate, in such cases, that food business operators,
responsible for the safety of the foods they place on the
market, assume the burden of proof in relation to their
safety.

(17)

The adoption of maximum amounts and any conditions
of use based on the application of the principles and
criteria stipulated in this Regulation and the adoption of
minimum amounts would be implementing measures of
a technical nature and their adoption should be entrusted
to the Commission in order to simplify and expedite the
procedure.

(21) Given the particular nature of foods to which vitamins
to those
and minerals are added, means additional
usually available to monitoring bodies should be available
in order
those
products.

to facilitate efficient monitoring of

(18) General labelling provisions and definitions are contained
in Directive 2000/13/EC of the European Parliament and
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 (1). This Regu-
lation should therefore be confined to the necessary addi-
tional provisions. Those additional provisions should also
apply without prejudice to Regulation (EC) No 1924/
2006 of the European Parliament and of the Council of

(22)

Since the objective of this Regulation, namely to ensure
the effective functioning of the internal market as regards
the addition of vitamins and minerals and certain other
substances to foods 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 prin-
ciple of proportionality, as set out in that Article, this
Regulation does not go beyond what
is necessary in
order to achieve that objective.

(1) 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).

(2) See page 9 of this Official Journal.
(3) 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).

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(23)

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),

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 (2);

(2) ‘other substance’ means a substance other than a vitamin or
a mineral that has a nutritional or physiological effect.

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.
This Regulation harmonises the provisions laid down by
law, regulation or administrative action in Member States which
relate to the addition of vitamins and minerals and of certain
other substances to foods, with the purpose of ensuring the
effective functioning of the internal market, whilst providing a
high level of consumer protection.

CHAPTER II

ADDITION OF VITAMINS AND MINERALS

Article 3

Requirements for the addition of vitamins and minerals

1.
Only vitamins and/or minerals listed in Annex I, in the
forms listed in Annex II, may be added to foods, subject to the
rules laid down in this Regulation.

The provisions of this Regulation regarding vitamins and
2.
minerals shall not apply to food supplements covered by Direc-
tive 2002/46/EC.

2.
Vitamins and minerals in a form that is bio-available to
the human body may be added to foods, whether or not they
are usually contained therein, in order to take into account, in
particular:

This Regulation shall apply without prejudice to specific

3.
provisions laid down in Community legislation concerning:

(a) foods for particular nutritional uses and, in the absence of
specific provisions, compositional
such
products rendered necessary by the particular nutritional
requirements of the persons for whom they are intended;

requirements of

(b) novel foods and novel food ingredients;

(c) genetically modified food;

(d) food additives and flavourings;

(e) authorised oenological practices and processes.

Article 2

Definitions

(a) a deficiency of one or more vitamins and/or minerals in the
population or
that can be
specific population groups
demonstrated by clinical or sub-clinical evidence of defi-
ciency or indicated by estimated low levels of
intake of
nutrients; or

(b) the potential to improve the nutritional status of the popula-
tion or specific population groups and/or correct possible
deficiencies in dietary intakes of vitamins or minerals due to
changes in dietary habits; or

(c) evolving generally acceptable scientific knowledge on the
role of vitamins and minerals in nutrition and consequent
effects on health.

3. Modifications to the lists referred to in paragraph 1 of this
Article shall be adopted in accordance with the procedure
referred to in Article 14(2), taking account of the opinion of the
Authority.

For the purposes of this Regulation:

(1) ‘Authority’ means the European Food Safety Authority estab-
lished by Regulation (EC) No 178/2002 of the European

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

Prior to making these modifications,
the Commission shall
carry out consultations with interested parties, in particular food
business operators and consumer groups.

(2) 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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Article 4

Article 6

Restrictions on the addition of vitamins and minerals

Vitamins and minerals may not be added to:

(a) unprocessed foodstuffs, including, but not limited to, fruit,

vegetables, meat, poultry and fish;

(b) beverages containing more than 1,2 % by volume of
alcohol, except and by way of derogation from Article 3(2),
to products:

(i) referred to in Article 44(6) and (13) of Council Regu-
lation (EC) No 1493/1999 of 17 May 1999 on the
common organisation of the market in wine (1); and

(ii) which were marketed prior to the adoption of

this

Regulation; and

(iii) which have been notified to the Commission by a

Member State in accordance with Article 11,

and provided that no nutrition or health claim is made.

Additional foods or categories of foods to which particular vita-
mins and minerals may not be added may be determined in
accordance with the procedure referred to in Article 14(2) in
the light of scientific evidence and taking into account their
nutritional value.

Article 5

Purity criteria

1.
The purity criteria for vitamin formulations and mineral
substances listed in Annex II shall be adopted in accordance
with the procedure referred to in Article 14(2), except where
they apply pursuant to paragraph 2 of this Article.

Conditions for the addition of vitamins and minerals

1. When a vitamin or a mineral is added to foods, the total
amount of
for whatever
the vitamin or mineral present,
purpose,
in the food as sold shall not exceed maximum
amounts that shall be set in accordance with the procedure
referred to in Article 14(2). The Commission may, to this end,
submit proposals for the maximum amounts by 19 January
2009 For concentrated and dehydrated products, the maximum
amounts set shall be those present in the foods when prepared
for consumption according to the manufacturer's instructions.

2.
Any conditions restricting or prohibiting the addition of a
specific vitamin or mineral to a food or a category of foods
shall be adopted in accordance with the procedure referred to in
Article 14(2).

3.
The maximum amounts referred to in paragraph 1 and
the conditions referred to in paragraph 2 shall be set taking into
account:

(a) upper safe levels of vitamins and minerals established by
scientific risk assessment based on generally acceptable
scientific data,
the
varying degrees of sensitivity of different groups of consu-
mers; and

taking into account, as appropriate,

(b) intakes of vitamins and minerals from other dietary sources.

4. When the maximum amounts referred to in paragraph 1
and the conditions referred to in paragraph 2 are set, due
account shall also be taken of reference intakes of vitamins and
minerals for the population.

2.
Purity criteria for vitamin formulations and mineral
substances listed in Annex II, specified by Community legisla-
tion for their use in the manufacture of foodstuffs for purposes
other than those covered by this Regulation, shall apply.

5. When the maximum amounts referred to in paragraph 1
and the conditions referred to in paragraph 2 are set for vita-
mins and minerals whose reference intakes for the population
are close to the upper safe levels, the following shall also be
taken into account, as necessary:

3.
For those vitamin formulations and mineral substances
listed in Annex II for which purity criteria are not specified by
are
and until
Community legislation,
adopted, generally acceptable purity criteria recommended by
international bodies shall be applicable and national
rules
setting stricter purity criteria may be maintained.

such specifications

(a) the contribution of individual products to the overall diet of
the population in general or of sub-groups of the popula-
tion;

(1) OJ L 179, 14.7.1999, p. 1. Regulation as last amended by Regulation

(EC) No 2165/2005 (OJ L 345, 28.12.2005, p. 1).

(b) the nutrient profile of the product established as provided

for by Regulation (EC) No 1924/2006.

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The addition of a vitamin or a mineral to a food shall
6.
result in the presence of that vitamin or mineral in the food in
at least a significant amount where this is defined according to
the Annex to Directive 90/496/EEC. The minimum amounts,
including any lower amounts, by derogation from the significant
amounts mentioned above, for specific foods or categories of
foods shall be adopted in accordance with the procedure
referred to in Article 14(2).

CHAPTER III

ADDITION OF CERTAIN OTHER SUBSTANCES

Article 8

Article 7

Substances prohibited, restricted or under Community
scrutiny

Labelling, presentation and advertising

The labelling, presentation and advertising of

1.
foods to
which vitamins and minerals have been added shall not include
any mention stating or implying that a balanced and varied diet
cannot provide appropriate quantities of nutrients. Where
appropriate, a derogation concerning a specific nutrient may be
adopted in accordance with the procedure referred to in
Article 14(2).

The labelling, presentation and advertising of

2.
foods to
which vitamins and minerals have been added shall not mislead
or deceive the consumer as to the nutritional merit of a food
that may result from the addition of these nutrients.

The procedure provided for

1.
in this Article shall be
followed where a substance other than vitamins or minerals, or
an ingredient containing a substance other than vitamins or
minerals, is added to foods or used in the manufacture of foods
under conditions that would result in the ingestion of amounts
of this substance greatly exceeding those reasonably expected to
be ingested under normal conditions of consumption of a
balanced and varied diet and/or would otherwise represent a
potential risk to consumers.

On its own initiative or on the basis of

2.
information
provided by Member States, the Commission may take a deci-
sion, following in each case an assessment of available informa-
tion by the Authority and in accordance with the procedure
the
referred to in Article 14(2),
substance or ingredient in Annex III. In particular:

if necessary,

to include,

Nutrition labelling of products to which vitamins and
3.
minerals have been added and which are covered by this Regu-
lation shall be compulsory. The information to be provided shall
consist of that specified in Article 4(1), Group 2 of Directive 90/
496/EEC and of the total amounts present of the vitamins and
minerals when added to the food.

(a) if a harmful effect on health has been identified,

the
substance and/or the ingredient containing the substance
shall:

(i) be placed in Annex III, Part A, and its addition to foods
or its use in the manufacture of foods shall be prohib-
ited; or

4.
The labelling of products to which vitamins and minerals
have been added may bear a statement indicating such addition
under the conditions laid down in Regulation (EC) No 1924/
2006.

(ii) be placed in Annex III, Part B, and its addition to foods
or its use in the manufacture of foods shall only be
allowed under the conditions specified therein;

This Article shall apply without prejudice to other provi-

5.
sions of food law applicable to specified categories of foods.

(b) if the possibility of harmful effects on health is identified
but scientific uncertainty persists, the substance shall be
placed in Annex III, Part C.

Rules for implementing this Article may be specified in

6.
accordance with the procedure referred to in Article 14(2).

3.
Community provisions applicable to specified foods may
provide for restrictions or prohibitions on the use of certain
substances in addition to those laid down in this Regulation.

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Food business operators, or any other interested parties,
4.
may at any time submit for evaluation to the Authority a file
containing the scientific data demonstrating the safety of a
substance listed in Annex III, Part C, under the conditions of its
use in a food or in a category of foods and explaining the
purpose of that use. The Authority shall inform without delay
the Member States and the Commission of the submission and
shall make the file available to them.

(f) the substances for which dossiers have been submitted as

provided for in Article 17(1)(b);

(g) information about the substances referred to in Annex III

and the reasons for their inclusion therein;

(h) information about the substances listed in Annex III, Part C,
whose use is generally allowed as referred to in Article 8(5).

3.

The Register shall be made available to the public.

5. Within four years from the date a substance has been
listed in Annex III, Part C, a decision shall be taken, in accord-
ance with the procedure referred to in Article 14(2) and taking
into account
the Authority on any files
submitted for evaluation as mentioned in paragraph 4 of this
Article,
to generally allow the use of a substance listed in
Annex III, Part C, or to list it in Annex III, Part A or B, as appro-
priate.

the opinion of

The Commission shall establish,

6.
in accordance with the
procedure referred to in Article 14(2), implementing rules for
the application of this Article, including rules concerning the
submission referred to in paragraph 4 of this Article.

CHAPTER IV

GENERAL AND FINAL PROVISIONS

Article 9

Community Register

1.
The Commission shall establish and maintain a Com-
munity Register on the addition of vitamins and minerals and
of certain other substances to foods, hereinafter referred to as
‘the Register’.

2.

The Register shall include the following:

(a) the vitamins and minerals which may be added to foods as

listed in Annex I;

(b) the vitamin formulations and mineral substances which may

be added to foods as listed in Annex II;

(c) the maximum and minimum amounts of vitamins and
minerals which may be added to foods and any associated
conditions set in accordance with Article 6;

(d) the information regarding national provisions on the
mandatory addition of vitamins and minerals referred to in
Article 11;

(e) any restrictions on the addition of vitamins and minerals as

set out in Article 4;

Article 10

Free movement of goods

Without prejudice to the Treaty, in particular Articles 28 and 30
thereof, Member States may not restrict or forbid trade in foods
which comply with this Regulation and Community acts
adopted for its implementation by the application of non-
harmonised national provisions governing the addition of vita-
mins and minerals to foods.

Article 11

National provisions

By 19 July 2007, Member States shall inform the Commis-
1.
sion of existing national provisions on the mandatory addition
of vitamins and minerals and of products covered by the dero-
gation provided for in Article 4(b).

If a Member State, in the absence of Community provi-

2.
sions, considers it necessary to adopt new legislation:

(a) on the mandatory addition of vitamins and minerals to

specified foods or categories of foods; or

(b) on the prohibition or restriction on the use of certain other

substances in the manufacture of specified foods,

it shall notify the Commission in accordance with the procedure
laid down in Article 12.

Article 12

Notification procedure

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

it

2.
The Commission shall consult the Committee referred to
in Article 14(1), 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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The Member State concerned may take the envisaged
3.
measures only six months after the notification referred to in
paragraph 1, and provided that the Commission's opinion is not
negative.

If the Commission's opinion is negative, it shall determine, in
accordance with the procedure referred to in Article 14(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 13

Safeguard measures

1. Where a Member State has serious grounds for consid-
ering that a product endangers human health despite complying
that Member State may temporarily
with this Regulation,
suspend or restrict application of the provisions in question
within its territory.

It shall immediately inform the other Member States and the
Commission thereof and give reasons for its decision.

In accordance with the procedure referred to in Article 14
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 or restriction until the decision referred to
in paragraph 2 has been notified to it.

Article 14

Committee procedure

1.
The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health established
by Article 58(1) of Regulation (EC) No 178/2002, hereinafter
referred to as ‘the Committee’.

3.

The Committee shall adopt its Rules of Procedure.

Article 15

Monitoring

To facilitate efficient monitoring of foods to which vitamins and
minerals have been added, and of foods containing substances
listed in Annex III, Parts B and C, 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 providing a model of the label
used for the product. In such cases, information on the with-
drawal of the product from the market may also be required.

Article 16

Evaluation

By 1 July 2013, the Commission shall submit to the European
Parliament and the Council a report on the effects of imple-
menting this Regulation, in particular concerning the evolution
of the market in foods to which vitamins and minerals have
been added, their consumption, nutrient intakes for the popula-
tion and changes in dietary habits, and the addition of certain
other substances, accompanied by any proposals for amendment
of this Regulation which the Commission deems necessary. In
this context Member States shall provide the necessary relevant
information to the Commission by 1 July 2012. Rules for
implementing this Article shall be specified in accordance with
the procedure referred to in Article 14(2).

Article 17

Transitional measures

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.

1.
By way of derogation from Article 3(1) and until 19
January 2014, Member States may allow in their territory the
use of vitamins and minerals not listed in Annex I, or in forms
not listed in Annex II, provided that:

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

(a) the substance in question is used for addition to foods
marketed in the Community on 19 January 2007; and

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(b) the Authority has not given an unfavourable opinion in
respect of the use of that substance, or its use in that form,
in the manufacture of
food, on the basis of a dossier
supporting use of the substance in question to be submitted
to the Commission by the Member State not later than 19
January 2010.

2.
Until 19 January 2014, Member States may, in compliance
with the rules of the Treaty, continue to apply existing national
restrictions or bans on trade in foods to which vitamins and
minerals not included in the list in Annex I or in the forms not
listed in Annex II are added.

3. Member States may, in compliance with the rules of the
Treaty, continue to apply existing national provisions on
maximum and minimum amounts of vitamins and minerals
listed in Annex I added to foods and on the conditions applic-

able to this addition until the adoption of corresponding Com-
munity measures in accordance with Article 6 or under other
specific Community provisions.

Article 18

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.

Foods placed on the market or labelled prior to 1 July 2007
which do not comply with this Regulation may be marketed
until their expiry date, but not later than 31 December 2009.

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 I

VITAMINS AND MINERALS WHICH MAY BE ADDED TO FOODS

1. Vitamins

Vitamin A

Vitamin D

Vitamin E

Vitamin K

Vitamin B1

Vitamin B2

Niacin

Pantothenic acid

Vitamin B6

Folic acid

Vitamin B12

Biotin

Vitamin C

2. Minerals

Calcium

Magnesium

Iron

Copper

Iodine

Zinc

Manganese

Sodium

Potassium

Selenium

Chromium

Molybdenum

Fluoride

Chloride

Phosphorus

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VITAMIN FORMULATIONS AND MINERAL SUBSTANCES WHICH MAY BE ADDED TO FOODS

ANNEX II

1. Vitamin formulations

VITAMIN A

retinol

retinyl acetate

retinyl palmitate

beta-carotene

VITAMIN D

cholecalciferol

ergocalciferol

VITAMIN E

D-alpha-tocopherol

DL-alpha-tocopherol

D-alpha-tocopheryl acetate

DL-alpha-tocopheryl acetate

D-alpha-tocopheryl acid succinate

VITAMIN K

phylloquinone (phytomenadione)

VITAMIN B1

thiamin hydrochloride

thiamin mononitrate

VITAMIN B2

riboflavin

riboflavin 5'-phosphate, sodium

NIACIN

nicotinic acid

nicotinamide

PANTOTHENIC ACID

D-pantothenate, calcium

D-pantothenate, sodium

dexpanthenol

VITAMIN B6

pyridoxine hydrochloride

pyridoxine 5'-phosphate

pyridoxine dipalmitate

FOLIC ACID

pteroylmonoglutamic acid

VITAMIN B12

cyanocobalamin

hydroxocobalamin

BIOTIN

D-biotin

VITAMIN C

L-ascorbic acid

sodium-L-ascorbate

calcium-L-ascorbate

potassium-L-ascorbate

L-ascorbyl 6-palmitate

2. Mineral substances

calcium carbonate

calcium chloride

calcium salts of citric acid

calcium gluconate

calcium glycerophosphate

calcium lactate

calcium salts of orthophosphoric acid

calcium hydroxide

calcium oxide

calcium sulphate

magnesium acetate

magnesium carbonate

magnesium chloride

magnesium salts of citric acid

magnesium gluconate

magnesium glycerophosphate

magnesium salts of orthophosphoric acid

magnesium lactate

magnesium hydroxide

magnesium oxide

magnesium sulphate

ferrous carbonate

ferrous citrate

ferric ammonium citrate

ferrous gluconate

ferrous fumarate

ferric sodium diphosphate

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ferrous lactate

ferrous sulphate

ferric diphosphate (ferric pyrophosphate)

ferric saccharate

elemental
reduced)

iron (carbonyl + electrolytic + hydrogen

cupric carbonate

cupric citrate

cupric gluconate

cupric sulphate

copper lysine complex

sodium iodide

sodium iodate

potassium iodide

potassium iodate

zinc acetate

zinc chloride

zinc citrate

zinc gluconate

zinc lactate

zinc oxide

zinc carbonate

zinc sulphate

manganese carbonate

manganese chloride

manganese citrate

manganese gluconate

manganese sulphate

sodium bicarbonate

sodium carbonate

sodium citrate

sodium gluconate

sodium lactate

sodium hydroxide

sodium salts of orthophosphoric acid

sodium selenate

sodium hydrogen selenite

sodium selenite

sodium fluoride

potassium fluoride

potassium bicarbonate

potassium carbonate

potassium chloride

potassium citrate

potassium gluconate

potassium glycerophosphate

potassium lactate

potassium hydroxide

potassium salts of orthophosphoric acid

chromium (III) chloride and its hexahydrate

chromium (III) sulphate and its hexahydrate

ammonium molybdate (molybdenum (VI))

manganese glycerophosphate

sodium molybdate (molybdenum (VI))

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SUBSTANCES WHOSE USE IN FOODS IS PROHIBITED, RESTRICTED OR UNDER COMMUNITY SCRUTINY

ANNEX III

Part A — Prohibited substances

Part B — Restricted substances

Part C — Substances under Community scrutiny