II 
(Non-legislative acts)  
REGULATIONS  
COMMISSION REGULATION (EU) No 382/2010  
of 5 May 2010  
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 food 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 appli ­
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 
referred to as the Authority.  
(3) Following receipt of an application the Authority is to 
inform without delay the other Member States and the 
Commission and to deliver an opinion on a 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 The Natural Push-Up 
Company, submitted on 28 November 2008 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 Natural Push-Up® Tablets 
and Natural Push-Up® Capsules on female breast 
enhancement (Question No EFSA-Q-2008-784) (  2 ). The 
claim proposed by the applicant was worded as 
follows: ‘NPU Tablets imitate female breasts enhancement 
process by 8-PN (8-Prenylnaringenin)’.  
(6) On 5 June 2009, 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 Natural Push-Up® Tablets and 
Natural Push-Up® Capsules 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 Clasado Ltd., submitted on 
29 December 2008 pursuant to Article 13(5) of Regu ­
lation (EC) No 1924/2006, the Authority was required to 
deliver an opinion on a health claim related to the effects 
of Bimuno  BT (BGOS) Prebiotic on maintaining a healthy 
gastro-intestinal function (Question No EFSA-Q-2009- 
00231) (  3 ). The claim proposed by the applicant was 
worded as follows: ‘Helps maintain a healthy gastro- 
intestinal (GI) function’.  
(8) On 7 July 2009, 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 Bimuno  BT (BGOS) Prebiotic 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.EN 6.5.2010 Official Journal of the European Union L 113/1  
( 1 ) OJ L 404, 30.12.2006, p. 9.  ( 2 ) The EFSA Journal  (2009) 1100, 1-9.  
( 3 ) The EFSA Journal  (2009) 1107, 1-10.(9) Following an application from Clasado Ltd., submitted on 
15 July 2008 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 Bimuno  BT (BGOS) Prebiotic on support of the 
immune system (Question No EFSA-Q-2009-00230) (  1 ). 
The claim proposed by the applicant was worded as 
follows: ‘Supports your natural defences’.  
(10) On 7 July 2009, 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 Bimuno  BT (BGOS) Prebiotic 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) Following an application from Sunstar Suisse S.A., 
submitted on 4 February 2009 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 Gum Periobalance  TM 
tablets and chewing gum on oral health (Question No 
EFSA-Q-2009-00373) (  2 ). The claim proposed by the 
applicant was worded as follows: ‘Gum Periobalance  TM , 
combined with a correct oral hygiene, helps re-balancing 
the oral microflora and improving oral health’.  
(12) On 20 July 2009, 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 Gum Periobalance  TM tablets 
and chewing gum and the claimed effect. Accordingly, as 
the claim does not comply with the requirements of 
Regulation (EC) No 1924/2006, it should not be auth ­
orised.  
(13) 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.  
(14) Health claims referred to in Article 13(1)(a) of Regulation 
(EC) No 1924/2006 are subject to the transition 
measures laid down in Article 28(5) of that Regulation 
only if they comply with the conditions therein 
mentioned, among which that they have to comply 
with the Regulation. As for the four claims subject to 
the present Regulation, the Authority concluded that a 
cause and effect relationship had not been established 
between the consumption of the foods and the claimed 
effects and thus they do not comply with the Regulation 
(EC) No 1924/2006, they could not benefit from the 
transition period foreseen in Article 28(5) of that Regu ­
lation. A transition period of six months is provided for 
to enable food business operators to adapt to the 
requirements laid down in this Regulation.  
(15) The measures provided for in this Regulation are in 
accordance with the opinion of the Standing 
Committee on the Food Chain and Animal Health and 
neither the European Parliament nor the Council have 
opposed them,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Health claims set out in the Annex to this Regulation shall not 
be included in the Community list of permitted claims as 
provided for in Article 13(3) of Regulation (EC) No 1924/2006.  
However, they may continue to be used for six months after the 
entry into force of this Regulation.  
Article 2  
This Regulation shall enter into force on the 20th day following 
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, 5 May 2010.  
For the Commission  
The President  
José Manuel BARROSOEN L 113/2 Official Journal of the European Union 6.5.2010  
( 1 ) The EFSA Journal  (2009) 1106, 1-8.  
( 2 ) The EFSA Journal  (2009) 1178, 1-8.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 on newly developed 
scientific evidence and/or 
including a request for the 
protection of proprietary data  Natural Push-Up® Tablets and 
Natural Push-Up® Capsules  NPU Tablets imitate female 
breasts enhancement process 
by 8-PN (8-Prenylnaringenin)  Q-2008-784  
Article 13(5) health claim 
based on newly developed 
scientific evidence and/or 
including a request for the 
protection of proprietary data  Bimuno  BT (BGOS) Prebiotic  Helps maintain a healthy 
gastro-intestinal (GI) function  Q-2009-00231  
Article 13(5) health claim 
based on newly developed 
scientific evidence and/or 
including a request for the 
protection of proprietary data  Bimuno  BT (BGOS) Prebiotic  Supports your natural defences  Q-2009-00230  
Article 13(5) health claim 
based on newly developed 
scientific evidence and/or 
including a request for the 
protection of proprietary data  Gum Periobalance  TM tablets 
and chewing gum  Gum Periobalance  TM , combined 
with a correct oral hygiene, 
helps re-balancing the oral 
microflora and improving oral 
health  Q-2009-00373EN 6.5.2010 Official Journal of the European Union L 113/3