HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 119/12
EN
Official Journal of the European Union
4.5.2012
COMMISSION REGULATION (EU) No 379/2012
of 3 May 2012
refusing to authorise certain health claims made on foods, other than those referring to the
reduction of disease risk and to children’s development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
a cause and effect relationship had not been established
between the consumption of Lactobacillus rhamnosus GG
and the claimed effect. Accordingly, as the claim does
Having regard to the Treaty on the Functioning of the European
not comply with the requirements of Regulation (EC)
Union,
No 1924/2006, it should not be authorised.
Having regard to Regulation (EC) No 1924/2006 of the
European Parliament and of the Council of 20 December
(7) Following
an
application
from
Gelita
AG,
submitted
2006 on nutrition and health claims made on foods ( 1 ), and
pursuant to Article 13(5) of Regulation (EC) No
in particular Article 18(5) thereof,
1924/2006, the Authority was required to deliver an
opinion on a health claim related to the effects of
collagen hydrolysate on maintenance of joints
Whereas:
(Question No EFSA-Q-2011-00201)
( 3 ). The claim
proposed by the applicant was worded as follows: ‘Char
acteristic collagen peptide mixture (collagen hydrolysate)
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
having a beneficial physiological effect on the main
made on foods are prohibited unless they are authorised
tenance of joint health in physically active people’.
by the Commission in accordance with that Regulation
and included in a list of permitted claims.
(8)
On 20 July 2011, the Commission and the Member
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
States received the scientific opinion from the Authority,
cations for authorisations of health claims may be
which concluded that on the basis of the data presented,
submitted by food business operators to the national
a cause and effect relationship had not been established
competent authority of a Member State. The national
between the consumption of collagen hydrolysate and
competent authority is to forward valid applications to
the claimed effect. Accordingly, as the claim does not
the European Food Safety Authority (EFSA), hereinafter
comply with the requirements of Regulation (EC) No
referred to as ‘the Authority’.
1924/2006, it should not be authorised.
(3)
Following receipt of an application the Authority is to
inform without delay the other Member States and the
(9) The
health
claims
subject
to
this
Regulation
are
health
claims as referred to in point (a) of Article 13(1) of
Commission thereof and to deliver an opinion on the
Regulation (EC) No 1924/2006 and may benefit from
health claim concerned.
the transitional period laid down in Article 28(5) of
that Regulation. As the Authority concluded that cause
(4)
The Commission is to decide on the authorisation of
and effect relationships have not been established
health claims taking into account the opinion delivered
between the foods and the claimed effects, the claims
by the Authority.
do not comply with Regulation (EC) No 1924/2006,
and therefore they may not benefit from the transitional
period provided for in that Article.
(5) Following
an
application
from
Valio
Ltd,
submitted
pursuant to Article 13(5) of Regulation (EC) No
1924/2006, the Authority was required to deliver an
(10) In
order
to
ensure
that
this
Regulation
is
fully
complied
opinion on a health claim related to the effects of Lacto
with, both food business operators and the national
bacillus rhamnosus GG (LGG) on maintenance of defence
competent authorities should take the necessary actions
against pathogenic gastrointestinal micro-organisms
to ensure that, at the latest six months following the
(Question No EFSA-Q-2010-01028)
( 2 ). The claim
entry into force of this Regulation, the health claims
proposed by the applicant was worded as follows: ‘Lac
listed in its Annex are no longer used.
tobacillus GG helps to maintain defence against intestinal
pathogens’.
(11) The
comments
from
the
applicants
and
the
members
of
(6) On
1
June
2010,
the
Commission
and
the
Member
the public received by the Commission pursuant to
States received the scientific opinion from the Authority,
Article 16(6) of Regulation (EC) No 1924/2006 have
which concluded that on the basis of the data presented,
been considered when setting the measures provided
for in this Regulation.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 2 ) The EFSA Journal 2011; 9(6):2167.
( 3 ) The EFSA Journal 2011; 9(7):2291.

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EN
4.5.2012 Official
Journal
of
the
European
Union L
119/13
(12) The
measures
provided
for
in
this
Regulation
are
in
2. However,
the
health
claims
referred
to
in
paragraph
1
accordance with the opinion of the Standing
used prior to the entry into force of this Regulation may
Committee on the Food Chain and Animal Health and
continue to be used for a maximum period of six months
neither the European Parliament nor the Council have
after the entry into force of this Regulation.
opposed them,
HAS ADOPTED THIS REGULATION:
Article 1
Article 2
1. The
health
claims
listed
in
the
Annex
to
this
Regulation This Regulation shall enter into force on the twentieth day
shall not be included in the Union list of permitted claims as
following that of its publication in the Official Journal of the
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 May 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX
Rejected health claims
Application — Relevant provisions Nutrient, substance, food
of Regulation (EC) No 1924/2006
or food category
Claim
EFSA opinion
reference
Article 13(5) health claim Lactobacillus
Lactobacillus GG helps to maintain defence Q-2010-01028
based on newly developed rhamnosus GG (LGG)
against intestinal pathogens
scientific evidence and/or
including a request for the
protection of proprietary data
Article 13(5) health claim Collagen hydrolysate Characteristic collagen peptide mixture Q-2011-00201
based on newly developed
(collagen hydrolysate) having a beneficial
scientific evidence and/or
physiological effect on the maintenance
including a request for the
of joint health in physically active people
protection of proprietary data

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Document Outline

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