Regulations: (Non-Legislative Acts)
12.3.
2015
EN
Official Journal of the European Union
L 67/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) 2015/402
of 11 March 2015
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,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006
on nutrition and health claims made on foods (1), and in particular Article 18(5) thereof,
Whereas:
(1)
Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are
authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.
(2)
Regulation (EC) No 1924/2006 also provides that applications 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
referred to as the Authority, for a scientific assessment, as well as to the Commission and the Member States for
information.
(3)
The Authority is to deliver an opinion on the health claim concerned.
(4)
The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by
the Authority.
(5)
Following an application from ICP Ltd, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006,
the Authority was required to deliver an opinion on a health claim related to the effects of Padina pavonica-extract
in Dictyolone and increase in bone mineral density (Question No EFSA-Q-2013-00249) (2). The claim proposed
by the applicant was worded as follows: improves bone density through calcitrophic effects and through the
physiological restoration of proteinous bone, particular in bone loss brought about by the aging process on
normal healthy persons.
(6)
On 10 January 2014, the Commission and the 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 Padina pavonica-extract in Dictyolone and the claimed effect. Accordingly, as the
claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
(7)
Following an application from Omikron Italia S.r.l., submitted pursuant to Article 13(5) of Regulation (EC)
No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the effects of
cytidine 5-diphosphocholine (CDP-choline or citicoline) and maintenance of normal vision (Question No EFSAQ-2013-00757) (3). The claim proposed by the applicant was worded as follows: CDP-choline in oral solution as
source of choline contributes to the maintenance of normal function of the ophthalmic nervous structures.
(1) OJ L 404, 30.12.2006, p. 9.
(2) EFSA Journal 2014;12(1):3518.
(3) EFSA Journal 2014;12(2):3575.
L 67/2
EN
Official Journal of the European Union
12.3.2015
(8)
On 21 February 2014, the Commission and the 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 cytidine 5-diphosphocholine and the claimed effect. Accordingly, as the
claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
(9)
Following an application from Hassia Mineralquellen GmbH & Co KG, submitted pursuant to Article 13(5) of
Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to the
effects of Rosbacher drive and increased attention (Question No EFSA-Q-2013-00444) (1). The claim proposed
by the applicant was, inter alia, worded as follows: helps/supports/maintains concentration.
(10)
On 24 February 2014, the Commission and the 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 Rosbacher drive and the claimed effect. Accordingly, as the claim does
not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.
(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 been considered when setting the measures provided for in
this Regulation.
(12)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The health claims listed in the Annex to this Regulation shall not be included in the Union list of permitted claims as
provided for in Article 13(3) of Regulation (EC) No 1924/2006.
Article 2
This Regulation shall enter into force on the twentieth day following that of 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 March 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) EFSA Journal 2014;12(2):3576.
12.3.2015
EN
Official Journal of the European Union
L 67/3
ANNEX
Rejected health claims
Application Relevant provisions
of Regulation (EC) No 1924/2006
Nutrient, substance, food
or food category
Claim
EFSA opinion reference
Article 13(5) health claim based Padina pavonica-extract
on newly developed scientific evi in Dictyolone
dence and/or including a request
for the protection of proprietary
data
Improves bone density through
calcitrophic effects and through
the physiological restoration of
proteinous bone, particular in
bone loss brought about by the
aging process on normal healthy
persons
Q-2013-00249
Article 13(5) health claim based Cytidine 5-diphospho
on newly developed scientific evi choline (CDP-choline or
dence and/or including a request citicoline)
for the protection of proprietary
data
CDP-choline in oral solution as
source of choline contributes to
the maintenance of normal
function of the ophthalmic ner
vous structures
Q-2013-00757
Article 13(5) health claim based Rosbacher drive
on newly developed scientific evi
dence and/or including a request
for the protection of proprietary
data
Helps/supports/maintains
centration
Q-2013-00444
con
