HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 299/4
EN
Official Journal of the European Union
17.11.2011
COMMISSION REGULATION (EU) No 1171/2011
of 16 November 2011
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,
fermented milk product helps maintain the upper
respiratory tract defences by helping to support
immune functions’.
Having regard to the Treaty on the Functioning of the European
Union,
(6) On
18
October
2010,
the
Commission
and
the
Member
States received the scientific opinion from the Authority,
which concluded that on the basis of the data presented,
Having regard to Regulation (EC) No 1924/2006 of the
a cause and effect relationship had not been established
European Parliament and of the Council of 20 December
between the consumption of Lactobacillus casei strain
2006 on nutrition and health claims made on foods ( 1 ), and
Shirota and the claimed effect. Accordingly, as the
in particular Article 18(5) thereof,
claim does not comply with the requirements of
Regulation (EC) No 1924/2006, it should not be
authorised.
Whereas:
(7) Following
an
application
from
Piimandusühistu
E-Piim
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
(Dairy Cooperative E-Piim), submitted pursuant to
made on foods are prohibited unless they are authorised
Article 13(5) of Regulation (EC) No 1924/2006, the
by the Commission in accordance with that Regulation
Authority was required to deliver an opinion on a
and included in a list of permitted claims.
health claim related to the effects of Lactobacillus
plantarum TENSIA TM in the semi-hard Edam-type ‘heart
cheese’ of Harmony TM and maintenance of normal blood
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
pressure (Question No EFSA-Q-2010-00950) ( 3 ). The
cations for authorisations of health claims may be
claim proposed by the applicant was worded as
submitted by food business operators to the national
follows: ‘Regular consumption (at least three weeks) of
competent authority of a Member State. The national
50 g/day Südamejuust (“heart cheese”) of Harmony TM
competent authority is to forward valid applications to
brand comprising probiotic Lactobacillus plantarum
the European Food Safety Authority (EFSA), hereinafter
TENSIA TM helps to maintain the cardio-vascular
referred to as ‘the Authority’.
system/heart health through reduction of blood pressure/
symbol of heart’.
(3)
Following receipt of an application the Authority is to
(8)
On 14 February 2011, the Commission and the Member
inform without delay the other Member States and the
States received the scientific opinion from the Authority,
Commission thereof and to deliver an opinion on the
which concluded that on the basis of the data presented,
health claim concerned.
a cause and effect relationship had not been established
between the consumption of Lactobacillus plantarum
TENSIA TM in the semi-hard Edam-type ‘heart cheese’ of
(4)
The Commission is to decide on the authorisation of
Harmony TM and the claimed effect. Accordingly, as the
health claims taking into account the opinion delivered
claim does not comply with the requirements of
by the Authority.
Regulation (EC) No 1924/2006, it should not be
authorised.
(5) Following
an
application
from
Yakult
Europe
BV,
submitted pursuant to Article 13(5) of Regulation (EC)
(9) The
health
claims
subject
to
this
Regulation
are
health
No 1924/2006, the Authority was required to deliver an
claim as referred to in point (a) of Article 13(1) of
opinion on a health claim related to the effects of live
Regulation (EC) No 1924/2006 and may benefit from
Lactobacillus casei strain Shirota and maintenance of the
the transitional period laid down in Article 28(5) of
upper respiratory tract defence against pathogens by
that Regulation. As the Authority concluded that cause
maintaining immune defences (Question No EFSA-Q-
and effect relationships have not been established
2010-00137) ( 2 ). The claim proposed by the applicant
between the foods and the claimed effects, the claims
was worded, inter alia, as follows: ‘Daily consumption
do not comply with Regulation (EC) No 1924/2006,
of live Lactobacillus casei strain Shirota as present in a
and therefore they may not benefit from the transitional
period provided for in that Article.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 2 ) The EFSA Journal 2010; 8(10):1860.
( 3 ) The EFSA Journal 2011; 9(2):1981.

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EN
17.11.2011 Official
Journal
of
the
European
Union
L
299/5
(10) In
order
to
ensure
that
this
Regulation
is
fully
complied
HAS ADOPTED THIS REGULATION:
with, both food business operators and the national
competent authorities should take the necessary actions
to ensure that, at the latest 6 months following the entry
Article 1
into force of this Regulation, products bearing the health
claims listed in its Annex are no longer present on the
1. The
health
claims
listed
in
the
Annex
to
this
Regulation
market.
shall not be included in the Union list of permitted claims as

provided for in Article 13(3) of Regulation (EC) No 1924/2006.
(11) The
comments
from
the
applicants
and
the
members
of
the public received by the Commission pursuant to
2. However,
products
bearing
these
health
claims
placed
on
Article 16(6) of Regulation (EC) No 1924/2006 have
the market or labelled prior to the date of entry into force of
been considered when setting the measures provided
this Regulation may remain on the market for a maximum
for in this Regulation.
period of 6 months after that date.
(12) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Article 2
Committee on the Food Chain and Animal Health and
neither the European Parliament nor the Council have
This Regulation shall enter into force on the 20th day following
opposed them,
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 Brussels, 16 November 2011.
For the Commission
The President
José Manuel BARROSO

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L 299/6
ANNEX
Rejected health claims
Application – Relevant provisions of Regulation
(EC) No 1924/2006
Nutrient, substance, food or food category Claim EFSA
opinion
reference
EN
Article 13(5) health claim based on newly developed Live Lactobacillus casei strain Shirota Daily
consumption
of
live Lactobacillus casei strain Shirota as present in a
Q-2010-00137

scientific evidence and/or including a request for the
fermented milk product helps maintain the upper respiratory tract defences
protection of proprietary data
by helping to support immune functions
Article 13(5) health claim based on newly developed Lactobacillus plantarum TENSIATM
Regular consumption (at least three weeks) of 50 g/day Südamejuust (‘heart
Q-2010-00950
scientific evidence and/or including a request for the
cheese’) of HarmonyTM brand comprising probiotic Lactobacillus plantarum
protection of proprietary data
TENSIATM helps to maintain the cardio-vascular system/heart health through
reduction of blood pressure/symbol of heart
Off
icial
Jour
nal
of
the
European
Union
17.11.2011

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