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4.5.2012 Official
Journal
of
the
European
Union L
119/9
COMMISSION REGULATION (EU) No 378/2012
of 3 May 2012
refusing to authorise certain health claims made on foods and referring to the reduction of disease
risk and to children's development and health
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(6) On the basis of the data presented, the Authority
concluded in its opinion received by the Commission
and the Member States on 13 April 2011 that a cause
Having regard to the Treaty on the Functioning of the European
and effect relationship had not been established between
Union,
the consumption of ProteQuine and increasing
suppressed concentrations of ScIgA and reducing the
risk of common cold and influenza. Accordingly, as
Having regard to Regulation (EC) No 1924/2006 of the
the claim does not comply with the requirements of
European Parliament and of the Council of 20 December
Regulation (EC) No 1924/2006, it should not be auth
2006 on nutrition and health claims made on foods ( 1 ), and
orised.
in particular Article 17(3) thereof,
(7) Following
an
application
from
SVUS
Pharma
a.s,
Whereas:
submitted pursuant to Article 14(1)(a) of Regulation
(EC) No 1924/2006, the Authority was required to
deliver an opinion on a health claim related to the
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims
made on foods are prohibited unless they are authorised
effects of ProteQuine, a mixture of free amino acids,
by the Commission in accordance with that Regulation
oligopeptides and nucleotides, and bovine lactoferrin on
and included in a list of permitted claims.
increase of suppressed concentrations of secretory

immunoglobulin A (ScIgA) and reduction of the risk of
common cold with sore throat (Question No EFSA-Q-
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
2008-398) ( 3 ). The claim proposed by the applicant was
cations for authorisations of health claims may be
worded as follows: "ProteQuine in combination with
submitted by food business operators to the national
bovine lactoferrin elevates/maintains the level of ScIgA
competent authority of a Member State. The national
on mucous membranes. Decreased or insufficient level
competent authority is to forward valid applications to
of ScIgA is a risk factor in the development of
the European Food Safety Authority (EFSA), hereinafter
common cold with sore throat and combination of
referred to as 'the Authority'.
ProteQuine with bovine lactoferrin reduces the risk of
the development of sore throat".
(3)
Following receipt of an application the Authority is to
inform without delay the other Member States and the
(8) On the basis of the data presented, the Authority
Commission thereof, and to deliver an opinion on the
concluded in its opinion received by the Commission
health claim concerned.
and the Member States on 13 April 2011 that a cause
and effect relationship had not been established between
the consumption of ProteQuine and bovine lactoferrin
(4)
The Commission is to decide on the authorisation of
and increasing suppressed concentrations of ScIgA and
health claims taking into account the opinion delivered
reduction of the risk of common cold with sore throat.
by the Authority.
Accordingly, as the claim does not comply with the
requirements of Regulation (EC) No 1924/2006, it
should not be authorised.
(5) Following
an
application
from
SVUS
Pharma
a.s,
submitted pursuant to Article 14(1)(a) of Regulation
(EC) No 1924/2006, the Authority was required to
(9) Following
an
application
from
CSL
-
Centro
Sperimentale
deliver an opinion on a health claim related to the
del Latte S.p.A., submitted pursuant to Article 14(1)(b) of
effects of ProteQuine, a mixture of free amino acids,
Regulation (EC) No 1924/2006, the Authority was
oligopeptides and nucleotides on increase of suppressed
required to deliver an opinion on a health claim related
concentrations of secretory immunoglobulin A (ScIgA)
to the effects of a combination of Lactobacillus delbrueckii
and reduction of the risk of influenza and common
subsp. bulgaricus strain AY/CSL (LMG P-17224) and
cold (Question No EFSA-Q-2008-397) ( 2 ). The claim
Streptococcus thermophilus strain 9Y/CSL (LMG
proposed by the applicant was worded as follows: "Prote
P-17225) on beneficial modulation of intestinal
Quine elevates/maintains the level of ScIgA on mucous
microflora (Question No EFSA-Q-2008-273) ( 4 ). The
membranes. Decreased or insufficient level of ScIgA is a
claim proposed by the applicant was worded as
risk factor in the development of common cold or
follows: "Maintaining the gut health by normalizing the
influenza".
intestinal flora".
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 3 ) The EFSA Journal 2011; 9(4):2129.
( 2 ) The EFSA Journal 2011; 9(4):2128.
( 4 ) The EFSA Journal 2011; 9(7):2288.

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L 119/10
EN
Official Journal of the European Union
4.5.2012
(10) On the basis of the data presented, the Authority
and Streptococcus thermophilus strain 9Y/CSL (LMG
concluded in its opinion received by the Commission
P-17225) was not made before 19 January 2008, the
and the Member States on 20 July 2011 that a cause
requirement provided for in Article 28(6)(b) is not
and effect relationship had not been established between
fulfilled, and the transition period laid down in that
the consumption of the combination of L. delbrueckii
Article is not applicable.
subsp. bulgaricus strain AY/CSL (LMG P-17224) and S.
thermophilus strain 9Y/CSL (LMG P-17225) and a
(15) However,
in
order
to
ensure
that
this
Regulation
is
fully
beneficial physiological effect related to the claimed
complied with, both food business operators and the
effect. Accordingly, as the claim does not comply with
national competent authorities should take the
the requirements of Regulation (EC) No 1924/2006, it
necessary actions to ensure that, at the latest six
should not be authorised.
months following the entry into force of this Regulation,
the health claims listed in its Annex that have been
(11) Following
an
application
from
the
European
Dietetic
submitted pursuant to Article 14(1)(b) of Regulation
Food Industry Association (IDACE), submitted pursuant
(EC) No 1924/2006 are no longer used.
to Article 14(1)(b) of Regulation (EC) No 1924/2006, the
Authority was required to deliver an opinion on a health
(16) The
comments
from
the
applicants
and
the
members
of
claim related to the effects of beta-palmitate on increased
the public received by the Commission pursuant to
calcium absorption (Question No EFSA-Q-2008-172) ( 1 ).
Article 16(6) of Regulation (EC) No 1924/2006 have
The claim proposed by the applicant was worded, inter
been considered when setting the measures provided
alia, as follows: "Beta palmitate enrichment contributes to
for in this Regulation.
increase calcium absorption".
(17) The
measures
provided
for
in
this
Regulation
are
in
(12) On the basis of the data presented, the Authority
accordance with the opinion of the Standing
concluded in its opinion received by the Commission
Committee on the Food Chain and Animal Health and
and the Member States on 28 July 2011 that the
neither the European Parliament nor the Council have
evidence provided was insufficient to establish a cause
opposed them,
and effect relationship between the consumption of
beta-palmitate and the claimed effect. Accordingly, as
HAS ADOPTED THIS REGULATION:
the claim does not comply with the requirements of
Article 1
Regulation (EC) No 1924/2006, it should not be auth
orised.
1. The
health
claims
listed
in
the
Annex
to
this
Regulation
shall not be included in the Union list of permitted claims as
(13) In
accordance
with
Article 28(6) of Regulation
(EC)
No 1924/2006, health claims referred to in its Article
provided for in Article 14(1) of Regulation (EC) No 1924/2006.
14(1)(b) and not authorised by a decision pursuant to
2. However,
health
claims
as
referred
to
in
Article
14(1)(b)
of
Article 17(3) of Regulation (EC) No 1924/2006 may
Regulation (EC) No 1924/2006 and referred to in paragraph 1
continue to be used for six months after the adoption
used prior to the entry into force of this Regulation, may
of this Regulation, provided an application was made
continue to be used for a maximum period of six months
before 19 January 2008. Accordingly, the transition
after the entry into force of this Regulation.
period laid down in that Article is applicable to the
health claim relevant to beta-palmitate listed in the
Article 2
Annex of this Regulation.
This Regulation shall enter into force on the twentieth day
(14) As
the
health
claim
application
relevant
to Lactobacillus
following that of its publication in the Official Journal of the
delbrueckii subsp. bulgaricus strain AY/CSL (LMG P-17224)
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
( 1 ) The EFSA Journal 2011; 9(7):2289.

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4.5.2012 Off
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 14(1)(a) health claim referring to a ProteQuine
ProteQuine elevates/maintains the level of ScIgA
Q-2008-397
reduction of a disease risk
on mucous membranes. Decreased or insufficient
level of ScIgA is a risk factor in the development
of common cold or influenza
Article 14(1)(a) health claim referring to a ProteQuine in combination with bovine lacto ProteQuine in combination with bovine lacto
Q-2008-398
reduction of a disease risk
ferrin
ferrin elevates/maintains the level of ScIgA on
mucous membranes. Decreased or insufficient
level of ScIgA is a risk factor in the development
of common cold with sore throat and
combination of ProteQuine with bovine lacto
icial
ferrin reduces the risk of the development of sore
throat
Jour
nal
Article 14(1)(b) health claim referring to children's Lactobacillus delbrueckii subsp. bulgaricus strain Maintaining the gut health by normalizing the
Q-2008-273
development and health
AY/CSL (LMG P-17224) and Streptococcus thermo intestinal flora
of
philus strain 9Y/CSL (LMG P-17225)
the
European
Article 14(1)(b) health claim referring to children's Beta palmitate Beta
palmitate
enrichment
contributes
to
increase
Q-2008-172
development and health
calcium absorption
Union
L
119/11

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Document Outline

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