Regulation (EC) No 107/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1924/2006 on nutrition and health claims made on foods as regards the implementing powers conferred on the Commission
Date: 2008-01-15
Institutions: Council of the European Union, European Parliament
Subjects: European Commission, foodstuff, health policy, labelling, nutrition, power of implementation

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Official Journal of the European Union

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REGULATION (EC) No 107/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 15 January 2008

amending Regulation (EC) No 1924/2006 on nutrition and health claims made on foods as regards the
implementing powers conferred on the Commission

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

prevent other applicants from applying for authorisation to
use the same claim.

Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

(5) Regulation (EC) No 1924/2006 should therefore be

amended accordingly,

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

HAVE ADOPTED THIS REGULATION:

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

Article 1

Whereas:

Regulation (EC) No 1924/2006 is hereby amended as follows:

the Council (3) provides

(1) Regulation (EC) No 1924/2006 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
instrument with new non-essential elements.

(3)

The Commission should be empowered to adopt Commu-
nity measures concerning the labelling, presentation and
advertising of certain foods; to establish derogations from
certain provisions of Regulation (EC) No 1924/2006; to
establish and update nutrient profiles and the conditions
and exemptions under which they can be used; to establish
and/or amend lists of nutrition and health claims; and to
amend the list of foods in respect of which the making of
claims is restricted or prohibited. 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
accordance with the regulatory procedure with scrutiny
provided for in Article 5a of Decision 1999/468/EC.

(4) When data protection provisions apply, the authorisation
restricted to use by an individual operator should not

(1) OJ C 325, 30.12.2006, p. 37.
(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. 9. Corrected by OJ L 12, 18.1.2007, p. 3.
(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).

1.

Article 1 shall be amended as follows:

(a)

in paragraph 2, the second subparagraph shall be
replaced by the following:

‘In the case of non-prepackaged foodstuffs (including
fresh products such as fruit, vegetables or bread) put
up for sale to the final consumer or to mass caterers
and foodstuffs packed at the point of sale at the
request of the purchaser or pre-packaged with a view
to immediate sale, Article 7 and Article 10(2)(a) and
(b) shall not apply. National provisions may apply
until the eventual adoption of Community measures
this
designed to amend non-essential elements of
Regulation,
in
alia, by supplementing it,
accordance with the
regulatory procedure with
scrutiny referred to in Article 25(3).’;

inter

(b)

paragraph 4 shall be replaced by the following:

For generic descriptors (denominations) which
‘4.
have traditionally been used to indicate a particularity
of a class of foods or beverages which could imply an
effect on human health, a derogation from paragraph 3
this
designed to amend non-essential elements of
Regulation by supplementing it may be adopted in
accordance with the
regulatory procedure with
scrutiny referred to in Article 25(3), on application
by the food business operators concerned. The
application shall be sent to the national competent
authority of a Member State which will forward it to
the Commission without delay. The Commission shall
adopt and make public the rules for food business
operators according to which such applications shall
be made, so as to ensure that the application is dealt
with transparently and within a reasonable time.’;

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2.

in Article 3, second paragraph, point (d) shall be replaced
by the following:

4.

Article 8(2) shall be replaced by the following:

‘(d)

state, suggest or imply that a balanced and varied diet
cannot provide appropriate quantities of nutrients in
general. Derogations in the case of nutrients for which
sufficient quantities cannot be provided by a balanced
and varied diet,
including the conditions for their
application, and designed to amend non-essential
elements of this Regulation by supplementing it may
be
regulatory
procedure with scrutiny referred to in Article 25(3),
taking into account the special conditions present in
Member States;’

adopted in accordance with the

3.

Article 4 shall be amended as follows:

(a)

paragraph 1 shall be amended as follows:

(i)

the first subparagraph shall be replaced by the
following:

‘1. By 19 January 2009, the Commission shall
including
establish specific nutrient profiles,
exemptions, which food or certain categories of
food must comply with in order
to bear
nutrition or health claims and the conditions
for the use of nutrition or health claims for foods
to the
or categories of
nutrient profiles. Such measures, designed to
amend non-essential elements of this Regulation
by supplementing it,
shall be adopted in
accordance with the regulatory procedure with
scrutiny referred to in Article 25(3).’;

foods with respect

(ii)

the sixth subparagraph shall be replaced by the
following:

‘Nutrient profiles and their conditions of use
designed to amend non-essential elements of this
Regulation by supplementing it shall be updated
to take into account relevant scientific develop-
ments in accordance with the regulatory proced-
ure with scrutiny referred to in Article 25(3) and
in
after
particular food business operators and consumer
groups.’;

interested parties,

consultation of

(b)

paragraph 5 shall be replaced by the following:

‘5. Measures determining the foods or categories of
foods other than those referred to in paragraph 3 for
which nutrition or health claims are to be restricted or
prohibited and designed to amend non-essential
this Regulation may be adopted in
elements of
accordance with the
regulatory procedure with
scrutiny referred to in Article 25(3) and in the light
of scientific evidence.’;

‘2. Amendments to the Annex shall be adopted in
accordance with the regulatory procedure with scrutiny
referred to in Article 25(3) and, where appropriate, after
consulting the Authority. Where appropriate, the Commis-
in particular food
sion shall
business operators and consumer groups,
in order to
evaluate the perception and understanding of the claims in
question.’;

involve interested parties,

5.

Article 13 shall be amended as follows:

(a)

paragraph 3 shall be replaced by the following:

‘3. After consulting the Authority, the Commission
in accordance with the regulatory
shall adopt,
procedure with scrutiny referred to in Article 25(3),
a Community list, designed to amend non-essential
elements of this Regulation by supplementing it, of
permitted claims as referred to in paragraph 1 and all
necessary conditions for the use of these claims by
31 January 2010 at the latest.’;

(b)

paragraph 4 shall be replaced by the following:

‘4. Any changes to the list referred to in paragraph 3,
based on generally accepted scientific evidence and
this
designed to amend non-essential elements of
Regulation by supplementing it, shall be adopted in
accordance with the
regulatory procedure with
scrutiny referred to in Article 25(3), after consulting
the Authority, on the Commission's own initiative or
following a request by a Member State.’;

6.

Article 17(3) shall be replaced by the following:

‘3. A final decision on the application, designed to amend
non essential elements of this Regulation by supplementing
it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 25(3).

However, where at the applicant's request for the protection
of proprietary data, the Commission proposes to restrict
the use of the claim in favour of the applicant:

(a)

(b)

a decision on the authorisation of the claim shall be
taken in accordance with the regulatory procedure
the
referred to in Article 25(2).
authorisation, if granted, shall expire after five years;

In such case,

before the expiry of the five-year period, if the claim
still meets the conditions laid down in this Regulation,
the Commission shall submit a draft of measures
designed to amend non-essential elements of
this
Regulation by supplementing it for authorisation of
the claim without restriction for use which shall be
regulatory
decided on in accordance with the
procedure with scrutiny referred to in Article 25(3).’;

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7.

in Article 18(4), the second subparagraph shall be replaced
by the following:

‘5. Where the Authority issues an opinion that does not
support the inclusion of the claim in the list referred to in
paragraph 4, a decision on the application designed to
amend non-essential elements of
this Regulation by
supplementing it shall be taken in accordance with the
regulatory procedure with scrutiny referred to in Arti-
cle 25(3).

However, where at the applicant's request for the protection
of proprietary data the Commission proposes to restrict the
use of the claim in favour of the applicant:

(a)

(b)

a decision on the authorisation of the claim shall be
taken in accordance with the regulatory procedure
referred to in Article 25(2).
the
authorisation, if granted, shall expire after five years;

In such case,

before the expiry of the five-year period, if the claim
still meets the conditions laid down in this Regulation,
the Commission shall submit a draft of measures
designed to amend non-essential elements of
this
Regulation by supplementing it for authorisation of
the claim without restriction of use which shall be
decided on in accordance with the
regulatory
procedure with scrutiny referred to in Article 25(3).’;

8.

in Article 20(2), second subparagraph, points 2 and 3 shall
be replaced by the following:

‘2.

3.

the fact that the Commission authorised the health
claim on the basis of proprietary data and restricted
use;

in the cases referred to in Article 17(3), second
subparagraph, and Article 18(5), second subpara-
graph, the fact that the health claim is authorised for a
limited duration.’;

9.

Article 25 shall be replaced by the following:

‘Article 25

Committee procedure

1. The Commission shall be assisted by the Committee.

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

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

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

10. Article 28 shall be amended as follows:

(a)

in the first subparagraph of paragraph 4, point (b)
shall be replaced by the following:

‘(b)

the Commission shall, in accordance with the
regulatory procedure with scrutiny referred to in
Article 25(3), adopt a decision concerning the
use of such claims and designed to amend non-
essential elements of this Regulation.’;

(b)

in paragraph 6(a), point (ii) shall be replaced by the
following:

‘(ii)

after consulting the Authority, the Commission
shall, in accordance with the regulatory proced-
ure with scrutiny referred to in Article 25(3),
adopt a decision concerning the health claims
authorised in this way and designed to amend
non-essential elements of
this Regulation by
supplementing it.’

Article 2

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