HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 182/8
EN
Official Journal of the European Union
12.7.2011
COMMISSION REGULATION (EU) No 666/2011
of 11 July 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,
Synbio on maintenance and improvement of intestinal
well-being (Question No EFSA-Q-2009-00889) ( 2 ). The
claim proposed by the applicant was worded as
follows: ‘Synbio persists in the intestinal tract and
Having regard to the Treaty on the Functioning of the European
favours the natural regularity contributing to maintain
Union,
and improve human intestinal well-being’.
Having regard to Regulation (EC) No 1924/2006 of the
(6) On
27
September
2010,
the
Commission
and
the
European Parliament and of the Council of 20 December
Member States received the scientific opinion from the
2006 on nutrition and health claims made on foods ( 1 ), and
Authority, which concluded that on the basis of the data
in particular Article 18(5) thereof,
presented, a cause and effect relationship had not been
established between the consumption of Synbio and the
claimed effect. Accordingly, as the claim does not comply
with the requirements of Regulation (EC) No 1924/2006,
Whereas:
it should not be authorised.
(1) Pursuant
to
Regulation
(EC)
No
1924/2006
health
claims (7) Following
an
application
from
MILTE
ITALIA
SpA,
made on foods are prohibited unless they are authorised
submitted pursuant to Article 13(5) of Regulation (EC)
by the Commission in accordance with that Regulation
No 1924/2006, the Authority was required to deliver an
and included in a list of permitted claims.
opinion on a health claim related to the effects of
Silymarin BIO-C on increase in production of breast
milk (Question No EFSA-Q-2009-00957) ( 3 ). The claim
proposed by the applicant was worded, inter alia, as
follows: ‘Suggested for improving the physiological
(2) Regulation
(EC)
No
1924/2006
also
provides
that
appli
production of breast milk during breast feeding’.
cations for authorisations of health claims may be
submitted by food business operators to the national
competent authority of a Member State. The national
competent authority is to forward valid applications to
the European Food Safety Authority (EFSA), hereinafter
(8) On
28
September
2010,
the
Commission
and
the
referred to as ‘the Authority’.
Member States received the scientific opinion from the
Authority, which concluded that on the basis of the data
presented, a cause and effect relationship had not been
established between the consumption of Silymarin
BIO-C and the claimed effect. Accordingly, as the
(3)
Following receipt of an application the Authority is to
claim does not comply with the requirements of
inform without delay the other Member States and the
Regulation (EC) No 1924/2006, it should not be auth
Commission thereof and to deliver an opinion on the
orised.
health claim concerned.
(9) All
the
health
claims
subject
to
this
Regulation
are
health
(4)
The Commission is to decide on the authorisation of
claims as referred to in point (a) of Article 13(1) of
health claims taking into account the opinion delivered
Regulation (EC) No 1924/2006 and may benefit from
by the Authority.
the transition period laid down in Article 28(5) of that
Regulation. As the Authority concluded that cause and
effect relationships have not been established between
the foods and the respective claimed effects, the two
(5) Following
an
application
from
Synbiotec
S.r.l.,
submitted
claims do not comply with Regulation (EC) No
pursuant to Article 13(5) of Regulation (EC) No
1924/2006, and therefore they may not benefit from
1924/2006, the Authority was required to deliver an
the transition period provided for in that Article.
opinion on a health claim related to the effects of
( 2 ) The EFSA Journal 2010; 8(9):1773.
( 1 ) OJ L 404, 30.12.2006, p. 9.
( 3 ) The EFSA Journal 2010; 8(9):1774.

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EN
12.7.2011 Official
Journal
of
the
European
Union L
182/9
(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
into force of this Regulation, products bearing the health
Article 1
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
Article 16(6) of Regulation (EC) No 1924/2006 have
2. However,
products
bearing
these
health
claims
placed
on
been considered when setting the measures provided
the market or labelled prior to the date of entry into force of
for in this Regulation.
this Regulation may remain on the market for a maximum
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, 11 July 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX
REJECTED HEALTH CLAIMS
Application – Relevant provisions of Regulation Nutrient, substance,
(EC) No 1924/2006
food or food category
Claim
EFSA opinion
reference
Article 13(5) health claim based on newly Synbio Synbio
persists
in
the
intestinal
Q-2009-00889
developed scientific evidence and/or
tract and favours the natural
including a request for the protection of
regularity contributing to
proprietary data
maintain and improve human
intestinal well-being
Article 13(5) health claim based on newly Silymarin BIO-C Suggested for improving the Q-2009-00957
developed scientific evidence and/or
physiological production of
including a request for the protection of
breast milk during breast feeding
proprietary data

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