Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
Date: 2008-01-15
Institutions: Council of the European Union, European Parliament
Subjects: consumer protection, foodstuffs legislation, mineral compound, vitamin

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REGULATION (EC) No 108/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 15 January 2008

amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain
other substances to foods

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

Having regard to the Treaty establishing the European Commu-
nity, 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:

the Council (3) provides

(1) Regulation (EC) No 1925/2006 of the European Parliament
and of
the regulatory
procedure established by Council Decision 1999/468/EC
of 28 June 1999 laying down the procedures for the
conferred on the
exercise of
Commission (4)
the adoption of
implementing measures concerning that Regulation.

implementing powers

is to be applied for

that

(2) Decision 1999/468/EC has been amended by Decision
2006/512/EC, which introduced the regulatory procedure
with scrutiny for the adoption of measures of general scope
and designed to amend non-essential elements of a basic
instrument adopted in accordance with the procedure
referred to in Article 251 of the Treaty, inter alia, by deleting
some of those elements or by supplementing the instru-
ment with new non-essential elements.

(3)

The Commission should be empowered to adopt modifica-
tions to Annexes I and II to Regulation (EC) No 1925/2006;
to establish additional foods to which particular vitamins or
minerals may not be added; to take decisions to establish
and/or amend the lists of authorised, prohibited or
restricted other substances; to define the conditions under
which vitamins and minerals may be used, such as purity
criteria, maximum amounts, minimum amounts and other
restrictions or prohibitions on the addition of vitamins and
minerals to food; and to establish derogations from certain
provisions of that Regulation. Since those measures are of
general scope and are designed to amend non-essential
elements of that Regulation, inter alia, by supplementing it
with new non-essential elements, they must be adopted in

(1) OJ C 325, 30.12.2006, p. 40.
(2) Opinion of

published in the Official
17 December 2007.

the European Parliament of 7 June 2007 (not yet
Journal) and Council Decision of

(3) OJ L 404, 30.12.2006, p. 26.
(4) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/

512/EC (OJ L 200, 22.7.2006, p. 11).

(4) When, on imperative grounds of urgency, the normal time-
limits for the regulatory procedure with scrutiny cannot be
complied with, the Commission should be able to use the
urgency procedure provided for in Article 5a(6) of Decision
1999/468/EC for
the deletion of certain vitamins or
minerals listed in the annexes and for the inclusion and
amendment of certain other substances in Annex III to
Regulation (EC) No 1925/2006.

(5) Regulation (EC) No 1925/2006 should therefore be

amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1925/2006 is hereby amended as follows:

1.

Article 3(3) shall be replaced by the following:

‘3. Modifications to the lists referred to in paragraph 1 of
this Article shall be adopted in accordance with the
regulatory procedure with scrutiny referred to in Arti-
cle 14(3), taking account of the opinion of the Authority.

On imperative grounds of urgency, the Commission may
use the urgency procedure referred to in Article 14(4) in
order to remove a vitamin or a mineral from the lists
referred to in paragraph 1 of this Article.

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

2.

in Article 4, the second paragraph shall be replaced by the
following:

‘Measures determining the additional foods or categories of
foods to which particular vitamins and minerals may not be
added and designed to amend non-essential elements of
this Regulation may be adopted in accordance with the
regulatory procedure with scrutiny referred to in Arti-
cle 14(3) in the light of scientific evidence and taking into
account their nutritional value.’;

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3.

Article 5(1) shall be replaced by the following:

the regulatory procedure with scrutiny referred to in
Article 14(3) of this Regulation.’;

‘1. Measures determining the purity criteria for vitamin
formulations and mineral substances listed in Annex II and
designed to amend non-essential elements of this Regula-
tion by supplementing it shall be adopted in accordance
with the regulatory procedure with scrutiny referred to in
Article 14(3), except where they apply pursuant
to
paragraph 2 of this Article.’;

4.

Article 6 shall be amended as follows:

(a)

paragraph 1 shall be replaced by the following:

‘1. When a vitamin or a mineral is added to foods,
the total amount of the vitamin or mineral present, for
whatever purpose, in the food as sold shall not exceed
maximum amounts. Measures setting that amount
and designed to amend non-essential elements of this
Regulation by supplementing it shall be adopted in
regulatory procedure with
accordance with the
scrutiny referred to in Article 14(3). The Commission
may, to this end, submit a draft of measures 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 manufac-
turer's instructions.’;

(b)

paragraph 2 shall be replaced by the following:

‘2. Any conditions restricting or prohibiting the
addition of a specific vitamin or mineral to a food or a
foods and designed to amend non-
category of
inter alia, by
essential elements of this Regulation,
supplementing it, shall be adopted in accordance with
the regulatory procedure with scrutiny referred to in
Article 14(3).’;

(c)

paragraph 6 shall be replaced by the following:

5.

Article 7(1) shall be replaced by the following:

‘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 and designed to amend non-essential
elements of this Regulation by supplementing it may be
adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 14(3).’;

6.

Article 8 shall be amended as follows:

(a)

paragraph 2 shall be replaced by the following:

‘2. On its own initiative or on the basis of
information provided by Member States, the Commis-
sion may take a decision designed to amend non-
essential elements of this Regulation, following in
each case an assessment of available information by
the Authority,
in accordance with the regulatory
procedure with scrutiny referred to in Article 14(3), to
include, if necessary, the substance or ingredient in
Annex III. In particular:

(a)

if a harmful effect on health has been identified,
the substance and/or the ingredient containing
the substance shall:

(i)

(ii)

be placed in Annex III, Part A, and its
addition to foods or
in the
manufacture of foods shall be prohibited;
or

its use

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

its use

‘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. Measures
the minimum
amounts, including any lower amounts, by derogation
from the significant amounts mentioned above, for
specific foods or categories of foods and designed to
amend non-essential elements of this Regulation by
supplementing it shall be adopted in accordance with

determining

(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.

On imperative grounds of urgency, the Commission
may use the urgency procedure referred to in
Article 14(4) in order to include the substance or
the ingredient in Annex III, Part A or B.’;

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(b)

paragraph 5 shall be replaced by the following:

established by Article 58(1) of Regulation (EC) No 178/
2002.

‘5. Within four years from the date a substance has
been listed in Annex III, Part C, a decision designed to
amend non-essential elements of this Regulation shall
be taken in accordance with the regulatory procedure
with scrutiny referred to in Article 14(3) and taking
into account the opinion of the Authority on any files
submitted for evaluation as mentioned in paragraph 4
to generally allow the use of a
of
substance listed in Annex III, Part C, or to list it in
Annex III, Part A or B, as appropriate.

this Article,

On imperative grounds of urgency, the Commission
may use the urgency procedure referred to in
Article 14(4) in order to include the substance or
the ingredient in Annex III, Part A or B.’;

7.

Article 14 shall be replaced by the following:

‘Article 14

Committee procedure

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

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

3. Where reference is made to this paragraph, Article 5a
(1) to (4), and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a
(1), (2) and (6), and Article 7 of Decision 1999/468/EC
shall apply, having regard to the provisions of Article 8
thereof.’

Article 2

1. The Commission shall be assisted by the Standing
Committee on the Food Chain and Animal Health

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

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

Done at Strasbourg, 15 January 2008.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

J.LENARČIČ