Common Position (EC) No 2/2006 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 the addition of vitamins and minerals and of certain other substances to foods
Date: 2005-12-08
Institutions: Council of the European Union
Subjects: consumer protection, food additive, food chemistry, foodstuffs legislation, inorganic chemical product, labelling, vitamin

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COMMON POSITION (EC) No 2/2006

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

(2006/C 80 E/02)

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

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

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)

There is a wide range of nutrients and other ingredients
including,
that might be used in food manufacturing,
but not limited to, vitamins, minerals including trace
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
harmonising national provisions relating to the addition
of vitamins 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
conditions of consumption of a balanced and varied diet
and/or would otherwise represent a potential risk to
consumers. In the absence of 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

(1) OJ C 112, 30.4.2004, p. 44.
(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).

Community provisions,
apply without prejudice to the provisions of the Treaty.

relevant national

rules may

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 volunta-
rily by food manufacturers or must be added as nutri-
tional substances as provided for by specific Community
legislation. 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 legisla-
tion. This Regulation should apply without prejudice to
the specific Community rules concerning the addition to
or use of vitamins and minerals to specific products or
groups of products or their addition for purposes other
than those covered by this Regulation.

detailed

on food

Given that
supplements
rules
containing vitamins and minerals have been adopted by
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 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 manu-
facturing, storage or handling procedures or to provide a
similar nutritional value to foods for which they are
intended as alternatives.

(3)

(4)

(5)

(6)

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

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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 popula-
tion 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 knowledge indicates that intakes of some nutri-
ents for maintaining 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
notified to the Commission. No claims about any nutri-
tional or health benefits of
the additions should be
made. Moreover, 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 effects and it
is therefore necessary to set
maximum safe levels for them when they are added to
foods, as the case may be. These levels must ensure that
the normal use of the products, under the instructions
for use provided by the manufacturer and in the context
of a diversified diet, will be safe for the consumer. There-
fore those levels 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 levels 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
potential intake from other foods. Due account should
also be taken of the population reference intakes of vita-
mins and minerals. Where it is necessary, for certain
vitamins and minerals, to establish restrictions regarding
the foods to which they can be added, 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 nutri-
tional value to foods for which those foods are intended
as alternatives.

provisions should also apply without prejudice to Regu-
lation (EC) No ../2006 of the European Parliament and
of the Council of …. 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 deroga-
tion 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. There-
fore it would be appropriate that the minimum amounts
of vitamins and minerals in foods to which vitamins and
minerals have been added should be the same as those
significant amounts that should be present for those
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
ingredients resulting from their
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 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 levels and any conditions of
use based on the application of
the principles and
criteria stipulated in this Regulation and the adoption of
minimum levels 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.

(18) General

and

labelling

provisions

definitions

are
the European
contained in Directive 2000/13/EC of
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 food-
stuffs (1). This Regulation should therefore be confined to
the necessary additional provisions. Those additional

(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).

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

(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
In
subsidiarity as set out in Article 5 of the Treaty.
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.

(2) Common position (EC) No 3/2006 (page … of this Official Journal).
(3) OJ L 276, 6.10.1990, p. 40. 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)

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),

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 (2).

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

This Regulation harmonises the provisions laid down by
1.
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
internal market, whilst
functioning of
providing a high level of consumer protection.

effective

the

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

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 requirements of such
products rendered necessary by the particular nutritional
requirements of the persons for whom they are intended;

(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

'Authority' means the
For the purposes of this Regulation,
European Food Safety Authority established by Regulation (EC)

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

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.

2.
Vitamins and minerals may be added to foods, whether
or not they are usually contained therein, in order to take into
account:

(a) a deficiency of one or more vitamins and/or minerals in the
population or specific population groups that can be
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 popu-
lation 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.

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

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

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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);

(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 vitamins 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.

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.

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

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). 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 the
following 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;

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.

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:

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

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

for by Regulation (EC) No .../2006 (*).

(1) OJ L 179, 14.7.1999, p. 1. Regulation as last amended by Commis-
sion Regulation (EC) No 1795/2003 (OJ L 262, 14.10.2003, p. 13).

(*) Regulation on nutrition and health claims from recital 18.

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6.
The addition of a vitamin or a mineral to a food shall
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 signifi-
cant 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

1.
The labelling, presentation and advertising of 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).

2.
The labelling, presentation and advertising of 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.

3.
Nutrition labelling of products to which vitamins and
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 Direc-
tive 90/496/EEC and of the total amounts present of the vita-
mins and minerals when added to the food.

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 …/
2006 (*).

This Article shall apply without prejudice to other provi-

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

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
referred to in Article 14(2),
the
substance or ingredient in Annex III. In particular:

if necessary,

to include,

(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

(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;

(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).

(*) Regulation on nutrition and health claims from recital 18.

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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4.
Food business operators, or any other interested parties
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.

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
appropriate.

the opinion of

6.
The Commission shall establish, 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;

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 … (*), Member States shall inform the Commission of
1.
existing national provisions on the mandatory addition of vita-
mins and minerals and of products covered by the derogation
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 proce-
dure laid down in Article 12.

Article 12

Notification procedure

(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;

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.

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

2.
The Commission shall consult the Committee referred to
in Article 14, if it considers such consultation to be useful or if
a Member State so requests, and shall give an opinion on the
envisaged measures.

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

set out in Article 4;

(*) Six months from the entry into force of this Regulation.

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3.
The Member State concerned may take the envisaged
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

that

a product

1. Where a Member State has serious grounds for consid-
endangers human health despite
ering
complying with this Regulation,
that Member State may
temporarily 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.

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

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 withdrawal of the product from the market may also be
required.

Article 16

Evaluation

By … (*), the Commission shall submit to the European Parlia-
ment and the Council a report on the effects of implementing
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 population
and changes in dietary habits, the addition of certain other
substances, accompanied by any proposals for amendment to
this Regulation which the Commission deems necessary. In this
context Member States shall provide the necessary relevant
information to the Commission by … (**). Rules for imple-
menting this Article shall be specified in accordance with the
procedure referred to in Article 14(2).

Article 14

Committee procedure

Article 17

Transitional measures

The Commission shall be assisted by the Standing
1.
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'.

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

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

1.
By way of derogation from Article 3(1) and until … (***),
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:

(a) the substance in question is used for addition to foods

marketed in the Community on … (****); and

(*) The first day of the sixth months following the date of entry into

force of this Regulation + six years.

(**) The first day of the sixth months following the date of entry into

force of this Regulation + five years.

(***) Seven years from the date of entry into force of this Regulation.
(****) The date of entry into force of this Regulation.

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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
… (*).

Until … (**), Member States may, in compliance with the
2.
rules of the Treaty, continue to apply existing national restric-
tions 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.

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 20th day
following its publication in the Official Journal of the European
Union.

It shall apply from … (***).

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

Foods placed on the market or labelled prior to … (***) which
do not comply with this Regulation may be marketed until
… (****).

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

(*) Three years from the date of entry into force of this Regulation.
(**) Seven years from the date of entry into force of this Regulation.

(***) The first day of the sixth months following the date of entry into

force of this Regulation.

(****) The last day of the 29th month following the date of entry into

force of this Regulation.

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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

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

pteroylmonoglutamic acid

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))

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

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. The Commission forwarded to Council on 14 November 2003 a proposal for a Regulation of the
European Parliament and of the Council on the addition of vitamins and minerals and of certain
other substances to foodstuffs. The proposal is based on Article 95 of the Treaty.

2. The European Parliament has adopted its opinion at first reading on 26 May 2005 (1).

The European Economic and Social Committee gave its opinion on 31 March 2004 (2).

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

the Treaty.

II. OBJECTIVE

The objective of the proposed Regulation is to harmonise the rules concerning the addition of vitamins
and minerals to foodstuffs. This is with a view to facilitating the free circulation of these products
within the Community as the existing relevant national rules on such addition vary widely and often
result in obstacles to intra-community trade.

Such harmonisation will also ensure a high level of consumer protection across the Community and
guarantee that products concerned do not present any risk for public health.

The proposed Regulation:

— lists the vitamins and the minerals which may be added to food (Annex I) and the forms in which

they may be added (Annex II),

— provides for certain restrictions regarding the foods to which vitamins and minerals may be added,
sets criteria for the establishment of maximum levels and provides for the setting of minimum
levels of vitamins and minerals to be found in the final product,

— sets out the rules on labelling, presentation and advertising of the products concerned,

— provides the basis for scrutinising and, where necessary, prohibiting the addition to foods of

certain substances other than vitamins and minerals.

— permits national measures on the mandatory addition of vitamins and minerals to foods provided

the opinion of the Commission on these measures is not negative.

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 limited number of modifications. These include:

— removing the definitions in Article 2 on the purposes of the addition of vitamins and minerals
to food in favour of explaining the circumstances in which vitamins and minerals may be added
to food in Article 3 (Requirements),

(1) Doc. 9200/05.
(2) OJ C 112, 30.4.2004, p. 44.

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— a more precise description of derogations applicable to Article 4 (outlining the cases where the

addition of vitamins and minerals may not take place) in relation to alcoholic beverages,

— streamlining the provisions applicable to substances other than vitamins and minerals (merging

Articles 10 and 11 of the original proposal),

— clarifying the procedures for notification of existing and new national provisions (new Article

11 and deletion of Article 9 of the original text).

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 46 amendments to the
proposal (Amendment 8 is linguistic and does not affect the English version).

The Council:

(a) introduced in the common position 20 amendments in full, in part or in principle, as follows:

recitals

Amendment 1 (to recital 10) and Amendment 2 (on recital 12): have been taken up in part, with
the deletion of the last sentence of recital 8 and a modification in recital 10.

Amendment 4 (to recital 20a): taken up in principle and in part in recital 2 (second sentence)
and in Article 11( 2).

Amendment 5 (to recital 20b): taken in principle via a rewording of Article 6(6).

Articles

Amendment 13 (to Article 3(3)): taken up in part, as regards the opinion of the Authority, while
the original reference to implementing rules has been deleted (given that there is no longer a
reference to restoration, nutritional equivalence and substitute foods in Articles 2 and 3).

Amendment 16 (to Article 4(1) (new)): maintained in substance in Article 17(1)(b) and Article
9(2)(d).

Amendment 17 (to Article 4(2)): introduced in part in Article 17(2).

Amendments 49/rev and 54/rev (to Article 5(1)(b)): fully taken up in Article 4.

Amendment 25 (to Article 7(5)): taken up in part (as regards the suggested deletion) in Article
6(6). In this context, the Council also notes that the Commission has the intention to revise and
update the reference values included in the Annex to Directive 90/496/EEC on nutrition label-
ling of foodstuffs.

Amendment 31 (to Article 9(2)(2)): the purpose of the Amendment is taken up in Article 9(2)(d)
(see also Article 11).

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Amendment 34 (to Article 10), Amendment 55 (on Article 10a (new)) and Amendment 35 (to
Article 11): have been taken up in Article 8. The suggested new Article 10a(3) can be found in
Article 11(2)(b).

Amendment 38 (to Article 12(2)(fa) and (fb) (new)): the intent of the amendment was partly
taken into consideration in Article 9(2)(d)).

Amendment 39 (to Article 13): the concern underlying the Amendment was partly taken up in
Article 11(2)(b) (as regards the introduction of new provisions).

Amendment 41 (to Article 16(1)): the principle is taken into account in Article 3(3), while the
Council does not consider that the Authority should be involved automatically whenever the
Committee procedure is invoked.

Amendment 44 (to Annex I) Amendment 45 (to Annex II) and Amendment 46 (to Annex II) are
fully integrated in the Annexes (with a rewording for Amendment 45 and a change of place-
ment for Amendment 46);

(b) did not include 26 amendments in the common position.

With respect to Amendments 3, 6, 9, 10, 14, 15, 19, 20, 21, 23, 24, 26, 27, 29, 30, 32, 36,
37,40 and 43, the Council followed the position expressed by the Commission.

As regards Amendments 21, 26 and 30, however, the Council notes the intention of the Commission
to:

— consider, in the framework of its reflection on the revision of Directive 90/496/EEC on nutrition

labelling of foodstuffs, the following elements in relation to vitamins and minerals:

— revising/updating reference values included in the Annex to Directive 90/496/EEC and the

levels that may be considered as significant amounts,

— establishing tolerance levels for acceptable variation from the declared value of added vita-

mins and minerals on the nutrition label,

— reflect any modification to the compulsory elements of nutritional labelling that may be adapted
in the future revision of nutrition labelling Directive, in Article 7(3) of the Regulation on the
addition of vitamins and minerals and of certain other substances to foods,

— present as soon as possible and in any case within two years following the adoption of the
Regulation a proposal for the establishment of maximum/ minimum amounts of vitamins and
minerals and any conditions for their addition to food as referred to in Article 6(2).

As regards Amendment 36, introducing a new Article 11a on labelling, presentation and advertising
of other substances, it should be noted that labelling rules can be considered by the Commission in
the context of Article 8(6), on the adoption of implementing rules to apply Article 8.

In relation to Amendments 11, 12, 22, 28,40 and 42, accepted in part by the Commission but not
included in the common position:

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Amendment 11 (to Article 3(2), introductory part): it can be pointed out that the principle of the
amendment, on the need for adding vitamins and minerals in a form that is bio-available to the
human body, is already outlined in the first sentence of recital 11.

Amendment 12 (to Article 3a (new)): and Amendment 28 (to Article 8(2)) the substance of these
amendments is maintained in Article 7 (2) as it is the labelling (including ingredient listing), presen-
tation and advertising which could mislead or deceive the consumer.

Amendment 22 (to Article 7(2)(b)): food supplements are considered implicitly covered by the para-
graph in question according to which 'other dietary sources' should be taken into account while
fixing the maximum amounts and the conditions for the addition of vitamins and minerals to food.

Amendment 40 (to Article 14(3)) can be found, in part and implicitly, in Article 12(3) second indent,
given that the consultation of the Committee becomes obligatory whenever the Commission's
opinion on the envisaged measure is negative.

Amendment 42 (to Article 17): the Council considers that, for the monitoring tasks carried out by
competent authorities, the obligation to notify the Commission of any placing on the market of
food products containing vitamins and minerals would not be compatible with the principles of
subsidiarity and proportionality.

3. Other innovations introduced by the Council

Other innovations introduced in the common position include:

— the grouping of all the applicable transitional measures in a new Article 17, with the deletion of

Article 4 of the original proposal,

— a revision of Articles 6 (on conditions on the addition of vitamins and minerals) and 7 (on label-

ling, presentation and advertising) following the deletion of the definitions in Article 2,

— a modification of Article 15 on monitoring, so that when a notification of placing on the
market is required, information on the withdrawal of the product from the market can also be
required,

— a reference to implementation rules for the application of Article 16,

— the deletion of sodium chloride from Annex II and with a corresponding modification of

Rrecital 11 explaining this change.

IV. CONCLUSION

The Council considers that its common position, which incorporates the amendments mentioned in
Sections III.2(a), takes good account of the opinion of the European Parliament in first reading and
represents a balanced solution to ensure that the objectives of the Regulation will be achieved.